September 2025 Newsletter
September 2025 Newsletter – CCTRIS Trials and Triumph: Clinical Research Chronicles September 2025 Edition Welcome Message Dear Readers, Welcome to the September 2025 edition of Trials and Triumph: Clinical Research Chronicles. This month, we spotlight a theme at the cutting edge of science and public health: Artificial Intelligence in Clinical Research: Promise, Pitfalls, and Progress. Artificial Intelligence (AI) is no longer a futuristic concept, it is already being integrated into how we design, run, and analyse clinical studies. From improving patient recruitment to powering diagnostic tools, AI holds enormous promise. But as with any innovation, we must remain alert to its risks, ensuring that equity, transparency, and ethics remain at the heart of research. We also bring you highlights from the IVON-PP Trial Close-Out and the Steering Committee Meeting of the CAPREMAN project — two milestones that mark CCTRIS’ continued leadership in maternal and newborn health research. We hope you enjoy this edition! Dr Kehinde Okunade Phase I & II Clinical Trial Lead, CCTRIS-UNILAG Artificial Intelligence in Clinical Research: Promise, Pitfalls, and Progress Artificial Intelligence (AI) is no longer science fiction, it’s quietly reshaping the way we live, work, and even care for our health. Clinical research is no exception. Across the world, AI is stepping into trials and studies in powerful ways: The Promise of AI Smarter Recruitment: helping match eligible participants faster and more efficiently Real-Time Monitoring: devices powered by AI, such as intrapartum monitoring tools, are improving patient safety during labour. Data at Scale: machine learning is uncovering patterns in massive datasets that humans could easily miss. Faster Discovery: AI is accelerating the search for promising new medicines The Pitfalls and Challenges But with every breakthrough comes a reminder of the challenges: Bias: if AI is trained on non-diverse data, it can widen existing health gaps Trust: people need to be confident their data is used responsibly Oversight: regulation is still catching up with the speed of technology The Path Forward For African research institutions like CCTRIS, AI is not just a tool to adopt; it’s an opportunity to lead. When African populations are represented in datasets, when we build strong local data science capacity, and when ethics are placed at the centre, AI can drive equity rather than exclusion. “The future of clinical research is not about replacing researchers with machines. It’s about equipping researchers with smarter tools — while keeping humanity at the centre of science.” Events & Spotlight Three Years, 1,400 Women, One Goal: Reducing Post-Partum Anaemia. (Trial Closeout and Dissemination Ceremony) The trial titled “Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP)” was set out to tackle one of the critical maternal health challenges in Nigeria; postpartum anaemia. After three years of groundbreaking work, the IVON-PP Trial has reached its conclusion. The IVON-PP Trial enrolled 1,400 postpartum women across 20 sites in Lagos, Kwara, Kano, and Rivers States, aiming to generate evidence for safer and more effective ways of treating postpartum anaemia. Why does this matter? Anaemia is a major contributor to maternal health complications and a significant cause of morbidity and mortality globally, especially in low and middle-income countries. By providing high-quality, locally relevant evidence, the IVON-PP Trial brings us closer to solutions that can transform maternal care in Nigeria and beyond. The Close-out Ceremony and Dissemination Meeting, taking place in Abuja on 16 October 2025, will serve as a platform to: Highlight the Trial’s contributions to shaping maternal and newborn health policy Share the key findings from three years of research Engage policymakers on pathways for integrating the evidence into national guidelines. The close-out is more than a formality, it is the bridge between science and policy, ensuring that the lessons of the IVON-PP Trial move from data to impact, for women across Nigeria. Spotlight: Dr. Opeyemi Akinajo at Goalkeepers 2025 We are proud to celebrate Dr. Opeyemi Akinajo, one of our emerging research leaders, who attended the Gates Foundation’s Goalkeepers 2025 Event in New York. At this gathering of global changemakers, Dr. Akinajo shared insights on how CCTRIS and partners are leveraging Artificial Intelligence in maternal and newborn health including real-time monitoring during labour to improve outcomes for mothers and babies. Her voice at this global stage reflects the rising impact of young African scientists and affirms CCTRIS’ mission to shape health innovations that resonate locally and globally. Research Highlight SPEC-AI Trial – Smarter Screening for Maternal Health The SPEC-AI Trial is breaking new ground in Nigeria by bringing Artificial Intelligence (AI) into maternal health research. Phase I of the study has already shown the promise of using AI to detect risks such as preeclampsia and peripartum cardiomyopathy earlier than traditional methods. Building on these results, the Trial is now moving into Phase II, expanding its reach and refining the technology to make it even more reliable and adaptable for real-world use. What makes this work especially exciting is how advanced the AI tool is becoming. It’s not just flagging risk factors, it is also beginning to predict biological age from health patterns, giving researchers and clinicians a new window into maternal wellbeing. This could help identify women whose bodies are under more strain than their chronological age suggests, allowing for earlier interventions and more personalised care. The SPEC-AI Trial is proof that innovation doesn’t only come from outside Africa. Here in Nigeria, we are shaping how the next generation of AI-powered health tools can serve women and families where the need is greatest. Did You Know? 🤖 Did you know? In 2022, the U.S. FDA reported that nearly 60% of drug development programs used AI at some stage of design or analysis. Yet, fewer than 10% included significant data from African populations — highlighting why local leadership in AI research is critical to building tools that work for our communities. © 2025 CCTRIS – Centre for Clinical Trials Research & Implementation Science. All rights reserved. Unsubscribe | Privacy Policy | Contact Us
August 2025 Newsletter
August 2025 Newsletter – CCTRIS Trials & Triumphs: Clinical Research Chronicles August 2025 Edition Welcome Message Dear Readers, Welcome to the August 2025 edition of Trials and Triumph: Clinical Research Chronicles. Drawing from a recent happening, the feature topic in this month’s discusses how misinformation can foster public mistrust in clinical research explored in the topic: Navigating Misinformation and Building Trust in Clinical Research. The Research Highlight section features an article on the topic: Time of onset of pre-eclampsia as a determinant of risk of cardiovascular disease and renal impairment at six weeks post-partum: a cohort study in Lagos, Nigeria. We are also requesting a call to researchers across the African continent to share available guidelines on Anaemia in Pregnancy and Postpartum in Africa within their countries to help drive one of our ongoing research on maternal anaemia management – CAPREMAN. We hope you enjoy reading this. Professor Titilope Adeyemo Deputy Director – Clinical Trials CCTRIS-UNILAG Navigating Misinformation and Building Trust in Clinical Research In our hyper-connected world, information, both true and false, spreads at an unprecedented pace. Recently, a rumor went viral on social media claiming that the Namibian Government had denied a renowned global non-profit organisation permission to conduct a clinical trial for a new contraceptive. The story, despite being completely unfounded, was amplified by countless shares and even picked up by otherwise respectable platforms. This incident underscores a persistent and critical challenge in global health research: public mistrust fueled by misinformation. The Challenge of Misinformation Clinical trials operate within a fragile ecosystem where trust is paramount. This trust can be undermined not only by genuine ethical lapses but also by false claims amplified through online platforms. In today’s digital landscape, a single unverified social media post can shape public perception more powerfully than a meticulously crafted research report. For researchers and institutions, this presents a dual responsibility: to generate trustworthy scientific evidence and to proactively engage with the public in ways that are clear, open, and responsive. The Role of Social Media Social media is not the enemy; it is a tool. Used well, it can support transparency, connect researchers with communities, and quickly correct falsehoods. But when unverified claims go unchecked, the cost is confusion, mistrust, and in some cases, reluctance to participate in future beneficial studies. This makes it essential for the research community to invest in proactive communication, media partnerships, and capacity-building around science literacy. Safeguarding Public Confidence In an era where a single rumor can influence global perception, safeguarding public confidence is no longer optional, it is a central pillar of sustaining trust in science. The lesson is clear: scientific evidence must not only be generated but also actively defended in the public square where narratives are contested and shared. 🕵🏽♂️ How to Spot Health Misinformation Online 1 Check the source – Is it from a peer-reviewed journal, official health agency, or recognised institution? 2 Look for evidence – Reliable claims cite data, reports, or studies, not just opinions. 3 Beware of sensationalism – If it sounds too shocking, it may be misleading. 4 Cross-verify – Check if reputable outlets are reporting the same story. 5 Pause before sharing – One click can amplify misinformation to thousands. Trust in clinical research grows when we share facts, not rumours Research Highlight Time of onset of pre-eclampsia as a determinant of risk of cardiovascular disease and renal impairment at six weeks post-partum: a cohort study in Lagos, Nigeria Pre-eclampsia, a serious blood pressure condition that can occur during pregnancy, has long been known to pose immediate risks to both mother and baby. However, the health effects for the mother may not end at delivery. A recent study published in BMJ Open sheds new light on the cardiovascular and renal risks women face in the weeks following a pregnancy complicated by pre-eclampsia. Designed as prospective cohort study, 44 women diagnosed with pre-eclampsia were followed, with the women categorised based on when their pre-eclampsia started: “early-onset” (before 34 weeks of gestation) or “late-onset” (at or after 34 weeks). Follow-up was from diagnosis through delivery and up to six weeks postpartum. At the six-week mark, they assessed several key health markers, including blood pressure, glucose tolerance, cholesterol levels (lipid profile), and kidney function (serum creatinine). The study revealed several important findings. Most notably, a large majority of the women did not return to normal blood pressure by their six-week postpartum check-up. Key Findings: Persistent High Blood Pressure: A staggering 81.8% of the women still had either prehypertension (75.0%) or hypertension (6.8%) six weeks after delivery. Only a small fraction (18.2%) had become normotensive. Early-Onset vs. Late-Onset: While the severity of the disease was similar between the two groups during pregnancy, there was a key difference in their postpartum health. Women who had early-onset pre-eclampsia had significantly higher levels of serum triglycerides compared to those with late-onset pre-eclampsia. Kidney Function: On a positive note, none of the women in the study showed signs of impaired kidney function at the six-week follow-up. Why Does It Matter? This research underscores that the health risks associated with pre-eclampsia extend beyond pregnancy and delivery. The high prevalence of persistent hypertension at six weeks postpartum is a critical finding, suggesting that many women remain at an elevated risk for future cardiovascular disease. The authors highlight that the standard six-week postpartum check-up may not be sufficient for this high-risk group, highlighting a call for re-evaluation of postpartum care protocols, and suggesting a need for longer and more comprehensive follow-up to monitor and manage cardiovascular risk factors in women with a history of pre-eclampsia. This could lead to earlier interventions and ultimately help prevent long-term heart and vascular problems. Read the full paper here: https://bmjopen.bmj.com/content/15/7/e094397 Call for Guidelines on Anaemia in Pregnancy and Postpartum in Africa Maternal anaemia continues to be a significant public health challenge. The Comprehensive Approach to the Prevention and Management of Maternal Anaemia in Nigeria (CAPREMAN) project is a research-driven initiative designed to tackle this burden by identifying gaps in care
July 2025 Newsletter
July 2025 Newsletter – CCTRIS Trials & Triumphs: Clinical Research Chronicles July 2025 Edition Welcome Message Dear Readers, 2025 has moved so fast and we can’t believe that we are past the halfway mark of the year already! Welcome to the July 2025 edition of Trials and Triumph: Clinical Research Chronicles. In this month’s edition, we explore how behavioural economics can influence and impact health decisions at individual and population level with the topic: Nudging Better Health: How Behavioural Economics Is Shaping Public Health Research. This edition also shares insights from some interesting events that held during the month – with the Q3 2025 edition of the quarterly CCTRIS Academic Seminar and the dissemination meeting of the LVASA-SRS project. One of our very own also got elected as a Fellow of the prestigious Nigeria Academy of Medicine. We hope you enjoy reading this. Professor Mobolanle Balogun Deputy Director – Implementation Science CCTRIS-UNILAG Nudging Better Health: How Behavioural Economics Is Shaping Public Health Research Understanding Behavioural Economics in Health Traditional public health approaches often assume people make decisions logically and consistently. However, behavioural economics challenges this notion by acknowledging that human behaviour is frequently influenced by cognitive biases, emotions, habits, and social context. In health research, these insights are being used to better understand why people make certain health choices, and how subtle changes in their environment can influence those decisions for the better. The Power of the “Nudge” At the heart of behavioural economics is the concept of the nudge, small, cost-effective interventions that guide individuals toward healthier behaviours without restricting their freedom of choice. Examples include: Sending SMS reminders to improve clinic attendance Reframing messages about vaccines to emphasise social responsibility Automatically scheduling follow-up appointments These nudges have proven effective across various settings, from increasing childhood immunisation rates to encouraging better dietary choices for patients attending outpatient diabetic clinics. From Theory to Practice: Applications in Research Public health researchers are increasingly embedding behavioural economics into their study designs. Randomised controlled trials now test behavioural interventions alongside traditional medical approaches. In maternal health, for example, behavioural nudges are being explored to improve antenatal care attendance. In infectious disease programmes, simplified communication and social norm messaging are helping reduce stigma and increase treatment adherence. Advancing Health Systems in LMICs In low- and middle-income countries, behavioural economics offers unique value. Many health challenges such as low facility delivery rates, poor follow-up, or vaccine hesitancy are not purely logistical but behavioural. Interventions that are grounded in behavioural science are helping address these barriers in a culturally sensitive and sustainable manner. In a world where evidence-based policy is essential, behavioural economics ensures that those policies are not only scientifically sound but also behaviourally informed, increasing the likelihood of real-world impact. Events and Spotlight July Academic Seminar – From Protocol to Proof On 18 July 2025, the CCTRIS Academic Seminar held at the Old Great Hall, College of Medicine, University of Lagos, featured an engaging session led by Dr Ibraheem Abioye, a physician, epidemiologist, and biostatistician. His lecture, “From Protocol to Proof: How Clinical Trials Deliver Trustworthy Evidence,” explored the core principles behind designing and conducting reliable clinical research. Dr Abioye emphasised that trustworthy evidence starts with well-considered trial design, and that randomisation and blinding serve as critical tools for ensuring fairness and objectivity. He also highlighted the importance of data quality, proper handling of missing values, and the impact of analysis choices—especially how intention-to-treat analysis reflects real-world effectiveness. The session provided valuable takeaways for researchers, clinicians, and students, reinforcing the fundamentals of rigorous trial methodology. 📺 Watch the full seminar on our YouTube channel: https://youtu.be/CMwRzEdYwGw LVASA-SRS Dissemination Meeting – Bridging Data and Policy for Maternal Health The LVASA-SRS Dissemination Meeting was held from 7 to 8 July 2025 at The Providence Hotel, Ikeja GRA, Lagos. Organised by CCTRIS in collaboration with the Lagos State Government, the two-day event convened a diverse group of stakeholders from the research, policy, and implementation landscape under the theme: “Knowledge Translation and Policy Engagement – Driving Evidence-Based Action to End Preventable Maternal and Perinatal Death.” The meeting showcased the technical and operational progress of the Lagos Verbal and Social Autopsy – Sample Registration System (LVASA-SRS) Project, featuring in-depth presentations on community-based surveillance, the use of verbal and social autopsy tools, digital dashboards for real-time data visualisation, and grief-sensitive, ethically grounded data collection. The project has successfully covered all 20 Local Government Areas in Lagos State, reaching over 126,000 households to uncover the biological and social causes of maternal and perinatal deaths. Distinguished attendees included the Honourable Commissioner for Health, the Special Adviser to the Governor on Health, Permanent Secretaries of the Ministry of Health and the Lagos State Primary Health Care Board, and several Directors across key departments. Also in attendance were LVASA-SRS co-investigators from LASUTH/LASUCOM and LUTH/CMUL, the technical partner from the African Population and Health Research Center (APHRC), and the dedicated technical and administrative team from CCTRIS. More than a dissemination forum, the event was a dynamic platform for shaping policy and driving sustainability. Discussions focused on integrating project findings into state health policy, enhancing civil registration and vital statistics systems, reinforcing legal frameworks for maternal death notification, and exploring scale-up potential across Nigeria. With notable media coverage by Arise TV, the LVASA-SRS Dissemination Meeting stood out as a national model of how data systems—when people-centred and policy-driven, can directly contribute to saving lives. Spotlight: Professor Titilope Adeyemo Elected Fellow of the Nigeria Academy of Medicine We are proud to celebrate our very own Professor Titilope A. Adeyemo, Deputy Director of Clinical Trials at CCTRIS and Professor of Haematology at the College of Medicine, University of Lagos, on her recent election as a Fellow of the Nigeria Academy of Medicine—a prestigious honour reserved for individuals who have made enduring contributions to medical science and health advancement in Nigeria. Professor Adeyemo’s election is a testament to decades of dedicated service to patient care, teaching, and groundbreaking research in sickle cell disease, transfusion medicine, and other haematological disorders.
June 2025 Newsletter
June 2025 Newsletter – CCTRIS Trials & Triumphs: Clinical Research Chronicles June 2025 Edition Welcome Message Dear Readers, Welcome to the June 2025 edition of Trials and Triumph: Clinical Research Chronicles. We open this month’s edition discussing From Evidence to Action: Strengthening Research Dissemination and Impact as our feature topic, exploring the importance of moving research beyond the pages of academic journals and into policy and practice. In our Spotlight section, we celebrate a landmark visit from Mr. Bill Gates, Chair of the Gates Foundation, to CCTRIS and the College of Medicine, University of Lagos, an inspiring testament to the global relevance of the impactful work we’re doing with the Foundation’s support. We also highlight a trio of academic promotions within our team, including our Deputy Director for Implementation Science, who was recently elevated to the rank of Professor. I hope you enjoy reading this. Dr Mobolanle Balogun Deputy Director (Implementation Science) – CCTRIS College of Medicine, University of Lagos Feature Article From Evidence to Action: Strengthening Research Dissemination and Impact Producing robust and relevant research is only the beginning, as the true value of scientific evidence lies in its ability to inform policy, transform practice, and improve lives. In clinical and public health research, effective dissemination is essential for ensuring that findings reach the right audiences in formats they can understand and use. This includes not only researchers and clinicians, but also policymakers, programme implementers, donors, and communities who are directly affected by the issues under study. Yet, dissemination without impact is simply noise. To translate research into change, dissemination efforts must be strategic, targeted, and intentional. This means tailoring messages to each stakeholder group, using appropriate language, media, and channels, and timing communications to align with decision-making cycles. In resource-limited settings, where health challenges are often urgent, this becomes even more critical. Tools and Strategies for Impactful Dissemination Several tools and frameworks can help research teams maximise the impact of their work: Stakeholder Mapping: Identifying key actors who influence or are influenced by your research enables more focused communication efforts. This includes policymakers, healthcare providers, advocacy groups, media, and beneficiaries. Policy Briefs and Evidence Summaries: Clear, concise, and action-oriented documents can bridge the gap between academic findings and policy or programme decisions. They highlight what was studied, why it matters, and what should happen next. Knowledge Translation Plans: These outline how research findings will be shared, with whom, and through what mechanisms. Good plans account for both passive dissemination (e.g., academic publications) and active engagement (e.g., stakeholder dialogues, media briefings, or community feedback sessions). Monitoring Impact: Tools such as altmetrics, policy citations, and stakeholder feedback help assess how research is being used and whether it is influencing change. By integrating these approaches early in the research lifecycle and not just after publication, researchers can ensure that their work does not simply sit on shelves or in desk drawers but contributes meaningfully to evidence-informed decision-making and improved health outcomes. Events and Spotlight Celebrating Academic Promotions at CCTRIS We are proud to celebrate a remarkable academic milestone within our Centre. Dr. Mobolanle Balogun, Deputy Director for Implementation Science at CCTRIS, has been promoted to the rank of Professor of Public Health in the Department of Community Health and Primary Care, College of Medicine, University of Lagos. This well-deserved elevation reflects her outstanding contributions to public health research, teaching, and capacity-building. We also extend hearty congratulations to two of our senior researchers, Dr. Doyin Ogunyemi and Dr. Esther Oluwole, on their promotion to Associate Professor in Public Health. Their dedication to advancing knowledge, mentorship, and strengthening public health systems continues to make an impact both within and beyond the Centre. CCTRIS Welcomes Bill Gates to the College of Medicine, University of Lagos Wednesday, 4 June 2025 marked a momentous day for the Centre for Clinical Trials, Research, and Implementation Science (CCTRIS) and the College of Medicine, University of Lagos, as we had the distinguished honour of welcoming Mr. Bill Gates, Chair of the Gates Foundation, for a high-level visit. Mr. Gates’ visit was a powerful affirmation of the impactful research and partnerships being driven by CCTRIS, particularly through its extensive portfolio of projects supported by the Gates Foundation. During the visit, Mr. Gates engaged with our team to review the progress of ongoing initiatives, assess their real-world impact, and discuss strategic directions for future collaboration. A key highlight of the day was his hands-on interaction with one of our upcoming innovations—AI-powered intrapartum monitoring devices, a promising project poised to advance maternal health outcomes in Nigeria and beyond. This visit reflects the strength of the collaboration between CCTRIS and the Gates Foundation, a partnership grounded in shared goals to advance health equity and strengthen clinical research capacity in Africa. We extend our sincere appreciation to Mr. Gates and the entire Gates Foundation team for their continued support and commitment to science-driven progress. Later that evening, Lagos played host to the Goalkeepers “Africa in Motion” event—a first for the city. Themed “The Future of Progress: Africa in Motion,” the event showcased African innovation and leadership, bringing together global changemakers passionate about building a healthier, more equitable future. At CCTRIS, we remain deeply committed to this mission and are proud to be part of the transformative work supported by the Gates Foundation. Invitation to the CCTRIS Academic Seminar | July Edition Join us this July as we unpack how strong trial design, rigorous implementation, and thoughtful interpretation work together to generate credible, real-world evidence in clinical research. Topic: From Protocol to Proof: How Clinical Trials Deliver Trustworthy Evidence Keynote Speaker: Dr. Ibrahim Abioye (Associate Researcher, CCTRIS; Medical Director, Genentech Inc., USA; Faculty Lead, StatsClinic) 🗓 Date: Friday, 18 July 2025 🕘 Time: 9:00 AM (WAT) 📍 Venue: Old Great Hall, College of Medicine, University of Lagos (CMUL, UNILAG) Participation is free, but registration is required. 🔗 Register here Did You Know? The concept of precision public health is gaining traction as a way to improve how health interventions are designed and delivered. Borrowing
May 2025 Newsletter
Trials & Triumphs: Clinical Research Chronicles May 2025 Edition Welcome Message Dear Readers, Welcome to the May 2025 edition of Trials and Triumph: Clinical Research Chronicles. In this month’s edition, we continue the discussion around the debate on the relevance of the p-value in clinical research by exploring the topic: Reframing the P-Value Debate: A Call for Responsible Use, Not Rejection. In our Research Highlight: From E6(R2) to E6(R3): Key Terminology Changes and Structural Modifications, we explore the key changes and modifications to the ICH GCP guidelines as we prepare to transition from the E6(R2) to the E6(R3). We also celebrate two key members of our team who made significant career milestones during the month. I hope you enjoy reading this. Dr Mobolanle Balogun Deputy Director (Implementation Science) – CCTRIS College of Medicine, University of Lagos Feature Article Reframing the P-Value Debate: A Call for Responsible Use, Not Rejection In the April edition, we explored the difference between statistical significance and clinical significance, highlighting the importance of interpreting research findings through both lenses. Continuing that conversation, it’s important to acknowledge the growing debate around one of the most commonly used statistical tools in clinical research: the p-value. In recent years, the p-value—a foundational tool in statistical inference, has come under intense scrutiny. Critics argue that it oversimplifies research findings into binary categories of “significant” and “non-significant,” contributing to a replication crisis in science. Some journals have gone as far as banning the use of p-values altogether. However, emerging consensus among statisticians and clinical researchers calls not for the abandonment of p-values, but for their proper use and contextual interpretation. P-values are not inherently flawed. When applied correctly, they provide a consistent, objective measure of how likely it is to observe the data assuming a null hypothesis is true. Their misuse—such as p-hacking, selective reporting, or blind adherence to arbitrary thresholds like p < 0.05, is a reflection of broader research culture challenges, not a failure of the method itself. Rather than banning p-values, experts recommend pairing them with effect sizes, confidence intervals, and clear reporting standards, and viewing them as one component in a larger evidentiary framework that includes clinical significance, biological plausibility, and study design quality. Calls to eliminate p-values risk replacing one imperfect tool with others that are equally susceptible to misinterpretation or misuse. As the field moves forward, the priority should be on improving statistical literacy, promoting open science, and encouraging nuanced data interpretation. A well-reported p-value, embedded within a transparent and clinically informed research narrative, remains a powerful asset in advancing medical science. Research Highlight From E6(R2) to E6(R3): Key Terminology Changes and Structural Modifications The transition from ICH GCP E6(R2) to E6(R3) marks a significant evolution in clinical trial guidelines, reflecting advancements in technology, trial design, and a heightened focus on participant-centric approaches. Below is a detailed comparison of the two versions: 1. Terminology Updates E6(R3) introduces updated terminology to better align with contemporary clinical research practices: Trial Participants: Previously referred to as “subjects” in E6(R2), the term has been updated to “trial participants” to emphasize respect and person-centered language. Service Provider: The term “Contract Research Organization (CRO)” has been broadened to “service provider,” encompassing a wider range of entities involved in trial activities. Essential Records: Formerly “essential documents,” this term now includes both documents and data (with relevant metadata) crucial for evaluating trial conduct and data reliability. Source Documents and Data Source Records: E6(R3) provides a more comprehensive definition, encompassing original documents or data (including metadata) irrespective of media, such as electronic patient-reported outcomes and data from wearables. 2. Structural Changes E6(R3) reorganizes the guideline to enhance clarity and applicability: Introduction and GCP Principles: A new section outlining foundational principles applicable across various trial types and settings. Annex 1: Details responsibilities of Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), investigators, sponsors, and introduces a new Data Governance section. Appendices: Provides guidance on the Investigator’s Brochure, Protocol, and Essential Records. Glossary: Expanded to include updated definitions reflecting current practices. 3. Emphasis on Quality and Risk Management E6(R3) places greater emphasis on proactive quality management and risk-based approaches: Quality by Design: Encourages integrating quality considerations into trial design and conduct from the outset. Risk Proportionality: Advocates for trial processes and measures proportionate to the risks to participants and the importance of the data collected. Data Governance: Introduces comprehensive guidance on data integrity, traceability, and protection throughout the data lifecycle. 4. Flexibility and Modernization Recognizing the evolving landscape of clinical research, E6(R3) accommodates modern trial designs and technologies: Innovative Trial Designs: Acknowledges adaptive, platform, and decentralized trials, providing guidance for their implementation. Technological Integration: Supports the use of electronic informed consent, remote monitoring, and digital health technologies. Proportional Implementation: Allows for flexibility in applying GCP principles based on trial complexity and risk. Events and Spotlight CCTRIS Hosts First Academic Seminar of the Year CCTRIS held its first academic seminar series for the year on 26 May 2025, featuring an engaging and insightful discussion on conducting clinical trials and the epidemiological principles underpinning such trials within our context, excellently delivered by Dr Kehinde S. Okunade, our Phase I/II Clinical Trials Lead. The session explored critical aspects of trial design, implementation, and interpretation relevant to low-resource settings. The virtual interactive event recorded strong participation, with attendees joining from various institutions across Nigeria and the African continent. The robust engagement reflects growing interest in strengthening clinical research capacity in Nigeria. If you missed the live session, the full recording is available on our YouTube channel: https://youtu.be/tw3zaS-pnA0 Stay tuned for announcements on upcoming seminars in this series—we look forward to your continued participation. Dr Babah bags her PhD in Global Public Health We’re thrilled to celebrate Dr. Ochuwa Babah, who successfully defended her PhD thesis on 15 May 2025 and has officially earned a PhD in Global Public Health from the prestigious Karolinska Institute in Sweden! Dr. Babah wears many hats—she’s our Phase III Clinical Trial Lead at CCTRIS and an Associate Professor of Obstetrics and Gynaecology at CMUL/LUTH.
April 2025 Newsletter
April 2025 Newsletter – CCTRIS Trials & Triumphs: Clinical Research Chronicles April 2025 Edition Welcome Message Dear Readers, Welcome to the April edition of Trials and Triumph: Clinical Research Chronicles. This month, we feature a compelling article titled Beyond the P-Value: Why Both Statistical and Clinical Significance Matter in Clinical Research, which explores how nuanced interpretation of data can lead to more meaningful healthcare interventions. In our Research Highlight, we examine the recent UN report: Aid Cuts Threaten Fragile Progress in Ending Maternal Deaths, with a special focus on Sub-Saharan Africa. Drawing attention to Nigeria’s alarming maternal mortality indices, the piece underscores the urgent need for domestic resource mobilisation to sustain progress in maternal health. One of our members was also recently elevated to the rank of full Professor, and we celebrate the hard work behind this outstanding feat. Sincerely, Professor Bosede B. Afolabi Director, CCTRIS College of Medicine, University of Lagos Feature Article Beyond the P-Value: Why Both Statistical and Clinical Significance Matter in Clinical Research In clinical research, demonstrating that a treatment works often involves two important concepts: statistical significance and clinical significance. Although they are sometimes mistakenly used interchangeably, they answer very different questions, and understanding both is crucial for interpreting study results accurately. Statistical significance tells us whether the results observed in a study are likely due to chance or reflect a true effect. It is commonly measured using a p-value, with a p-value less than 0.05 traditionally considered statistically significant. A statistically significant result suggests that there is a less than 5% probability that the observed difference happened by random chance. However, achieving statistical significance does not automatically imply that the observed difference is large, important, or meaningful for patients’ lives. Particularly in large trials, even very small effects can reach statistical significance. Clinical significance, by contrast, focuses on the practical importance of a treatment effect, whether it leads to a meaningful improvement in patient outcomes, health status, or quality of life. For instance, a drug might statistically lower blood pressure by 2 mmHg, but such a small reduction may not translate into a real-world benefit like reduced stroke risk. In this way, clinical significance bridges research findings with patient care, emphasising the value and relevance of the intervention to real health improvements. Both forms of significance must be carefully weighed together. A treatment that is statistically significant but not clinically meaningful might not justify a change in clinical practice, especially when considering costs, side effects, or patient burden. On the other hand, a clinically meaningful effect that narrowly misses statistical significance, perhaps due to a small sample size, might still warrant further study, rather than being dismissed outright. Researchers and healthcare decision-makers must look beyond p-values alone, considering the magnitude of benefit, patient-centred outcomes, and the broader context when interpreting study results. In an era increasingly focused on evidence-based and value-based care, balancing statistical rigour with clinical relevance is essential to ensure that research findings translate to tangible improvements at individual and population level. Research Highlight Aid Cuts Threaten Fragile Progress in Ending Maternal Deaths A recent joint report by the World Health Organization (WHO), UNICEF, and UNFPA, released on April 7, 2025, warns that global reductions in foreign aid are jeopardizing two decades of progress in reducing maternal mortality. While maternal deaths declined by 40% between 2000 and 2023, the pace of improvement has slowed significantly since 2016. In 2023 alone, approximately 260,000 women died from pregnancy-related causes—roughly one every two minutes. Key Findings The report highlights that recent aid cuts, particularly by major donors like the United States and the United Kingdom, have led to: Closure of clinics in vulnerable regions Layoffs of healthcare workers Disruptions in the supply of essential medicines These setbacks are especially severe in conflict-affected regions, where maternal mortality rates are already alarmingly high. Sub-Saharan Africa’s Maternal Health Crisis Sub-Saharan Africa remains the epicenter of the global maternal health crisis, with an average maternal mortality rate of 545 deaths per 100,000 live births in 2020. Countries like South Sudan and Chad report rates exceeding 1,000 deaths per 100,000 live births, while Nigeria follows closely with 1,047 deaths per 100,000 live births. In Nigeria alone, approximately 82,000 women die annually from pregnancy-related complications, accounting for 29% of global maternal deaths. To achieve the Sustainable Development Goal of reducing maternal mortality to fewer than 70 deaths per 100,000 live births by 2030, the current annual reduction rate must increase tenfold. UN agencies are calling for urgent investments in healthcare infrastructure, including the training and deployment of midwives, nurses, and community health workers, to prevent further regression and save lives. Given the volatility of international aid, there is an urgent need for domestic resource mobilization to close the funding gaps in maternal health programs. By increasing national health budgets and prioritizing maternal health, countries can build resilient healthcare systems capable of withstanding external shocks. Investing in local healthcare infrastructure, training, and community engagement is essential to ensure that every woman has access to safe and quality maternal healthcare, regardless of global funding fluctuations. Read more on the report here: https://www.who.int/publications/i/item/9789240108462 Upcoming Event CCTRIS Academic Seminar: “Conducting Clinical Trials: Epidemiological Principles” CCTRIS warmly invites you to its first Academic Seminar of 2025 titled “Conducting Clinical Trials: Epidemiological Principles.” This virtual session, taking place via Zoom on 26th May 2025 at 1 PM, will be led by Dr. Kehinde Okunade, Associate Professor of Obstetrics and Gynaecology and Phase I and II Clinical Trial Lead at CCTRIS. The seminar will explore key epidemiological principles that inform the design, conduct, and ethical robustness of clinical trials, especially in diverse settings like Nigeria. Whether you’re a student, researcher, or health professional interested in strengthening your trial design knowledge, this session is for you. Attendance is free; however register to attend via this link: https://us02web.zoom.us/webinar/register/WN_CWaBSDS1TJOetjufkmks6A Spotlight CCTRIS Celebrates Professor Christian C. Makwe’s Promotion CCTRIS proudly congratulates Professor Christian C. Makwe on his well-deserved promotion to the rank of Professor of Obstetrics and Gynaecology at the Lagos
March 2025 Newsletter
March 2025 Newsletter – CCTRIS Trials & Triumphs: Clinical Research Chronicles March 2025 Edition Welcome Message Dear Readers, Welcome to the March edition of Trials and Triumph: Clinical Research Chronicles. This month, we feature an article on Patient Registries: Unlocking Long-Term Insights in Clinical Research, highlighting their role in providing valuable data that drives better clinical outcomes and personalized treatments. In our Research Highlight, we celebrate our recent publication in PLOS Global Public Health on “Unravelling the Conundrums of Social Autopsy for Maternal Mortality in Low- and Middle-Income Countries”. This study sheds light on the complexities of social autopsy in understanding maternal deaths, offering important insights to inform policies and improve maternal health in resource-limited settings. Professor Titilope Adeyemo Deputy Director, Clinical Trials – CCTRIS College of Medicine, University of Lagos Feature Article Patient Registries: Unlocking Long-Term Insights in Clinical Research Patient registries are powerful tools in long-term clinical research, providing a structured system for systematically collecting and analysing patient data over extended periods. These registries track disease progression, treatment outcomes, and long-term safety profiles, offering invaluable real-world evidence that shapes clinical practice and healthcare policies. Types of Patient Registries Patient registries can be broadly categorised into different types based on their purpose and scope: Disease or Condition-Specific Registries: Focus on patients with a particular disease, such as cancer, diabetes, or rare genetic disorders, to study long-term outcomes, treatment efficacy, and disease patterns. Product or Drug Registries: Designed for post-market surveillance, these registries monitor the safety and effectiveness of new drugs, vaccines, or medical devices over time. Health Services Registries: Evaluate the performance of healthcare systems, tracking metrics such as hospital readmission rates, surgical outcomes, and quality of care. Population-Based Registries: Capture health data across a defined population, providing insights into public health trends, risk factors, and disease burden at a community or national level. Patient Registries and Real-World Evidence Patient registries are a critical source of real-world evidence (RWE), which refers to data collected outside controlled clinical trials to reflect how treatments perform in everyday healthcare settings. The integration of registries with electronic health records (EHRs), wearable health technologies, and administrative health data enhances their ability to generate high-quality RWE. This is particularly valuable for assessing long-term safety, effectiveness, and healthcare utilisation patterns in diverse patient populations. With advancements in big data analytics and artificial intelligence, patient registries are evolving into dynamic research platforms that not only support evidence-based medicine but also drive precision healthcare and policy development. Their role in bridging clinical research and real-world practice ensures that medical advancements translate into meaningful improvements in patient care. Research Highlight Unravelling the conundrums of social autopsy for maternal mortality in low- and middle-income countries Understanding the underlying causes of maternal mortality in low- and middle-income countries (LMICs) requires more than clinical diagnoses—it necessitates exploring the social, cultural, and systemic factors contributing to these deaths. Social autopsy has emerged as a valuable tool in this regard, offering insights beyond traditional verbal autopsies by examining the broader social determinants of maternal mortality. However, as highlighted in a recent publication from the LVASA-SRS project, the implementation of social autopsies is fraught with methodological and ethical challenges that demand careful consideration. Key Findings Three key conundrums were identified in conducting social autopsies: Defining the scope and participants of social autopsies remains contentious, with some approaches involving large community dialogues that may inadvertently foster blame and stigma. The methodological debate on whether social autopsies should be predominantly qualitative or quantitative raises concerns about the efficiency and effectiveness of existing tools. The appropriate scale of implementation remains unclear, as social factors influencing maternal deaths vary by context, yet overly localized reporting may compromise anonymity. Recommendations To address these challenges, there is a need for: A standardized, globally recognized framework for social autopsy, akin to the WHO’s guidance on verbal autopsies Prioritizing qualitative methods for deeper insights Ensuring psychosocial support for participants Balancing the need for detailed community-level analysis with safeguarding anonymity Ultimately, while social autopsies hold immense potential for shaping maternal health policies and interventions, ethical and methodological refinements are crucial to maximizing their impact while preserving the dignity of the deceased and their families. Read the full paper here: https://doi.org/10.1371/journal.pgph.0004295 Did You Know? Trillions of bacteria in your gut play a critical role in how your body processes medications. Recent research has shown that gut microbes can activate, inactivate, or even modify drugs, leading to significant variations in treatment responses between individuals. For instance, certain bacterial species can break down medications before they reach their intended target, reducing drug effectiveness. In contrast, some microbes can enhance drug absorption or convert inactive compounds into their active forms. This explains why two people taking the same medication at the same dose may experience different effects or side effects. Scientists are now exploring ways to personalize drug therapy by analyzing a patient’s microbiome, paving the way for more precise and effective treatments in the future. © 2025 CCTRIS. All rights reserved.
February 2025 Newsletter
February 2025 Newsletter – CCTRIS Trials & Triumphs: Clinical Research Chronicles February 2025 Newsletter Welcome Message Welcome to the February 2025 Edition of Trials & Triumphs: Clinical Research Chronicles! We are excited to continue advancing clinical research in 2025. This month, our Feature Topic explores Open Trials and the need for transparency and rigour in Clinical Research. In the Research Highlight section, we will take you through the series of interesting activities from the IVON-IS Dissemination Meeting, the LVASA Scientific and Data Analysis Meeting, and the inaugural CAPREMAN Stakeholders Meeting. Thank you for your feedback from the other editions. There is no need to download anymore, just click the link below to access the full edition for this month on our website. We remain committed and dedicated to give you insights from the centre. Sincerely,The CCTRIS Team. Feature Topic Open-Label Trials: Balancing Transparency and Rigour in Clinical Research Clinical trials vary in design, with open-label trials being those where both researchers and participants know the treatment being administered. Unlike blinded trials, which conceal treatment allocation to minimise bias, open-label trials prioritise transparency and practicality in specific research settings. When Are Open-Label Trials Used? Open-label trials are commonly employed when blinding is impractical or unnecessary, such as in: Comparative effectiveness studies, assessing real-world treatment outcomes. Long-term safety studies, monitoring prolonged effects of a drug. Rare or life-threatening conditions, where ethical considerations require treatment transparency. Dose-titration studies, allowing clinicians to adjust doses based on patient response. Hybrid effectiveness-implementation trials, where researchers evaluate both clinical efficacy and real-world adoption. Open-label designs in hybrid trials help assess how well an intervention works in routine practice, making them valuable for studying feasibility, patient adherence, and provider uptake. Advantages and Challenges of Open-Label Trial Design Open-label trials offer practical benefits, such as better patient adherence and real-world applicability. However, they also pose challenges, including bias risk and the potential for placebo effects, which can influence perceived outcomes. Researchers address these issues using robust statistical methods and hybrid trial designs. Why Open-Label Trials Matter Despite limitations, open-label trials remain essential in clinical research, particularly when controlled trials are not feasible. They provide valuable insights into treatment effectiveness, safety, and patient compliance, ensuring that promising therapies reach those who need them most. Research Highlight Section Verbal and Social Autopsy: Uncovering the Real Causes of Maternal Mortality Understanding the true burden of maternal deaths and stillbirths requires more than just numbers—it demands an in-depth exploration of the circumstances surrounding these tragedies. The Lagos State Verbal and Social Autopsy Sample Registration System (LVASA-SRS), implemented by CCTRIS across all 20 LGAs, employs Verbal Autopsy (VA) and Social Autopsy (SA) methods to generate reliable maternal mortality estimates while identifying key social and health system factors contributing to these deaths. How Verbal and Social Autopsy Work Verbal Autopsy (VA): VA is a structured interview conducted with caregivers, family members, or community respondents of a deceased individual to determine the probable medical cause of death. Standardised questionnaires are used to collect detailed accounts of symptoms, illness progression, and healthcare-seeking behaviour before death. This method is particularly useful in settings where civil registration systems are incomplete or cause-of-death certification is lacking. Social Autopsy (SA): While VA focuses on the medical causes, SA investigates the social, cultural, and health system barriers that may have contributed to the death. This includes delays in recognising danger signs, accessing healthcare facilities, financial constraints, and systemic gaps in maternal care. Why VA and SA Matter for Maternal Health By implementing VA and SA within the LVASA-SRS, CCTRIS aims to bridge the data gap on maternal deaths in Lagos State. The first phase of the project retrospectively examines maternal deaths and stillbirths from the past year, while the second phase will prospectively track such deaths over 12 months starting in 2024. The insights gained will provide evidence-based recommendations to policymakers, ensuring that maternal health interventions are responsive, targeted, and effective in reducing preventable deaths. Events and Spotlights LVASA-SRS Scientific Workshop on Maternal Mortality in Lagos To effectively tackle maternal mortality in Lagos State, accurate data on maternal deaths and their causes is essential. The Lagos State Verbal and Social Autopsy Sample Registration System (LVASA-SRS) project is addressing this gap by generating reliable data to inform targeted interventions. From 19th to 22nd February, LVASA-SRS held a 4-day scientific workshop to review findings from the past year. Supported by APHRC and LSHTM, the meeting brought together experts from LUTH, LASUTH, LSMOH, MIST, PHCB, and MPDSR to analyse maternal mortality trends and shape evidence-based policies for improved maternal health outcomes in Lagos. IVON-IS Stakeholders’ Dissemination Workshop The IVON-IS (Implementation Research for Intravenous Iron Use in Pregnant and Postpartum Nigerian Women) project held its Stakeholders’ Dissemination Workshop on Monday, 24th February 2025. The event featured presentations, panel discussions, and interactive sessions where stakeholders shared insights on improving anaemia care for pregnant and postpartum women. The study, conducted across six healthcare facilities in Lagos, demonstrated significant improvements in anaemia screening rates and IV iron administration, highlighting the effectiveness of targeted interventions. A key outcome of the workshop was the commitment from policymakers, healthcare providers, and community leaders to implement the study’s recommendations and scale up anaemia care services. The findings underscore the need for sustainable healthcare solutions to reduce anaemia-related morbidity and mortality in Nigeria. As stakeholders push for wider adoption of IV iron therapy, the study sets the stage for strengthening maternal healthcare and ensuring that all women receive timely and effective anaemia treatment. Inaugural Stakeholder Engagement Meeting for the CAPREMAN Project The MRH Collective, in collaboration with CCTRIS, held its inaugural stakeholder engagement meeting on 27th February in Abuja. The meeting convened key stakeholders from Lagos, Kano, Kaduna, and the Federal Ministry of Health to present findings from the IVON-IS project and introduce the Comprehensive Approach to the Prevention and Management of Maternal Anaemia in Nigeria (CAPREMAN) project. CAPREMAN aims to develop and implement a comprehensive guideline for the prevention and management of maternal anaemia. This mixed-method study, to be conducted in Kano,
January 2025 Newsletter
January 2025 Newsletter – CCTRIS Trials & Triumphs: Clinical Research Chronicles January 2025 Newsletter Welcome Message Welcome to the January 2025 Edition of Trials & Triumphs: Clinical Research Chronicles! A new year brings fresh opportunities, and we are excited to continue advancing clinical research in 2025. This month, our Feature Topic explores Hybrid Trials and their role in bridging controlled research with real-world healthcare solutions. In the Research Highlight section, we explore the Impact of Intravenous vs Oral Iron on Maternal Postpartum Recovery, drawing on key findings from the IVON Trial. Looking ahead, we are gearing up for key engagements, including the IVON-IS Dissemination Meeting, the LVASA Scientific and Data Analysis Meeting, and the inaugural CAPREMAN Stakeholders Meeting. Here’s to another year of groundbreaking research and impact. Happy New Year from all of us at CCTRIS! Sincerely,Dr. Mobolanle BalogunDeputy Director (Implementation Science) – CCTRISCollege of Medicine, University of Lagos. Feature Topic Hybrid Trials: Redefining Clinical Research for Real-World Solutions In clinical research, traditional trial designs often operate within fixed boundaries, focusing on either interventional studies (randomised controlled trials) or observational studies. However, hybrid trials have emerged as a powerful approach that combines elements of both, allowing researchers to evaluate interventions while also observing their implementation in real-world settings. What Are Hybrid Trials? Hybrid trials are designed to address both clinical efficacy and implementation outcomes. They often study how an intervention works in a controlled environment while simultaneously assessing its feasibility, acceptability, or scalability in routine practice. For example, a hybrid trial might evaluate the clinical effectiveness of a new diabetes medication while observing how easily healthcare providers integrate it into their workflows. Types of Hybrid Trials There are three common types of hybrid trials: Hybrid Type 1 Trial: Focuses on clinical efficacy while exploring preliminary implementation outcomes (e.g., feasibility, patient adherence). Hybrid Type 2 Trial: Balances attention between clinical and implementation outcomes, addressing both equally. Hybrid Type 3 Trial: Prioritises implementation outcomes, with less focus on clinical efficacy, often assuming the intervention’s effectiveness has already been established. Why Are Hybrid Trials Important? Hybrid trials are particularly valuable in bridging the gap between research and practice, ensuring that interventions proven effective in controlled settings can be successfully implemented in real-world healthcare systems. This dual focus accelerates the translation of research into practice, reduces delays in adopting new therapies, and generates insights into barriers and facilitators for widespread implementation. As clinical research evolves, hybrid trials exemplify the importance of designing studies that not only answer “Does it work?” but also “Can it work in the real world?” Research Highlight Section Impact of Intravenous vs Oral Iron on Maternal Postpartum Recovery: Findings from the IVON Trial Anaemia in pregnancy is a major public health concern, affecting maternal and neonatal outcomes. While intravenous (IV) iron therapy has been shown to replenish iron stores more effectively than oral iron, its role in postpartum recovery—particularly in relation to maternal mental health, breastfeeding, and neonatal well-being—remains unclear. This analysis, an extract from the IVON trial examines how IV ferric carboxymaltose compares with oral ferrous sulphate in influencing key postpartum outcomes among anaemic pregnant women in Nigeria. This study is part of the IVON trial, a multicentre, open-label, randomised controlled trial conducted across 11 healthcare facilities in Lagos and Kano, Nigeria. A total of 1,056 anaemic pregnant women (Hb 0.99), and vaccination rates at six weeks were nearly identical (88% IV vs 89% oral; RR 0.98, 95% CI 0.85–1.12; p=0.72). Conclusion: While IV iron was superior in correcting iron deficiency anaemia during pregnancy, it did not significantly impact postpartum depression, breastfeeding rates, or neonatal outcomes compared to oral iron. These findings suggest that while IV iron offers haematological benefits, its influence on broader maternal and neonatal health outcomes requires further investigation. Upcoming Events Dissemination Meeting: IVON-IS Project We are excited to share the findings and lessons learned from the Implementation Research for Intravenous Iron Use in Pregnant and Postpartum Nigerian Women (IVON-IS) project. After three years of implementation, the project has successfully concluded, offering valuable insights into strengthening routine anaemia screening and integrating intravenous iron therapy into maternal healthcare. The dissemination meeting, scheduled for February 24th, will present key results and discuss the conditions necessary within the health system to ensure effective delivery of intravenous iron to pregnant and postpartum women with moderate to severe anaemia. LVASA Scientific and Data Analysis Meeting In February, we will convene for the LVASA Scientific and Data Analysis Meeting, where we will review findings from the 1,800 Enumeration Areas (EAs) completed, codify collected data, conduct InterVA analysis, and outline the next steps for manuscript development and dissemination. This meeting is scheduled from February 19th to 22nd 2025. Inaugural Stakeholder Meeting: CAPREMAN Project Together with the MRH Research Collective, we are launching the Comprehensive Approach to the Prevention and Management of Maternal Anaemia in Nigeria (CAPREMAN) project, aimed at developing and implementing a comprehensive guideline for maternal anaemia prevention and management. This meeting will provide an opportunity to learn from the IVON-IS experience, introduce the CAPREMAN initiative, and engage key stakeholders—including representatives from the Ministry of Health, Kano, and Kaduna—to drive policy and implementation strategies. This event is scheduled to hold Feb 27th 2025. Did You Know? Adaptive consent models in clinical research provide a more flexible and participant-centred approach to informed consent, allowing for ongoing engagement and adjustments as a study progresses. Unlike traditional one-time consent, adaptive models enable participants to update their preferences, receive new information as it becomes available, and make informed decisions at different stages of the trial. This approach is particularly useful in long-term studies, precision medicine trials, and research involving emerging technologies, ensuring ethical transparency while enhancing participant autonomy and retention. © 2025 CCTRIS. All rights reserved.