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.
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 University Teaching Hospital (LUTH) and the College of Medicine, University of Lagos (CMUL).
Professor Makwe, who serves as the Clinical Governance Lead on our pivotal maternal health trial, AZIN-V, brings to the role a wealth of expertise, academic excellence, and an unwavering commitment to improving clinical research standards in Nigeria. This milestone is a testament to his outstanding contributions to clinical care, education, and research.
We celebrate this achievement with you and look forward to your continued leadership and impact within CCTRIS and beyond.
Did You Know?
Cancer cells can sometimes enter a dormant state, remaining inactive in the body for years or even decades before reactivating. These dormant cells can evade the immune system and resist treatments that target actively dividing cells, contributing to cancer recurrence long after initial therapy. Understanding the mechanisms behind cancer cell dormancy is crucial for developing strategies to prevent relapse. Recent research has explored the cellular, angiogenic, and immunological aspects of dormancy, aiming to uncover therapeutic approaches to target these elusive cells.