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.