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.
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. This achievement adds yet another feather to her cap. Congratulations to you on your double-D Dr2 Babah, we are super proud of you! 🎉👏
Cheers to Our Director, Professor Bosede B. Afolabi, FAS!
We're excited to celebrate a fantastic milestone—our very own Director, Professor Bosede B. Afolabi, has been conferred with the prestigious title of Fellow of the Nigerian Academy of Science (FAS) on the 22nd May, 2025, the highest scientific honour in the country!
This well-deserved recognition highlights her outstanding contributions to health sciences, medical research, and academia in Nigeria.
Congratulations, Professor Afolabi, FAS! We're proud to have you leading the way! 🎉
Did You Know?
Placebos are traditionally thought to work only when patients believe they are receiving an active treatment—but fascinating research shows that even when people know they're taking a placebo, it can still produce real symptom relief. These so-called open-label placebos have been shown to reduce pain, improve sleep, and ease symptoms in conditions like irritable bowel syndrome (IBS), chronic pain, and depression.
Scientists believe that the act of taking a pill with a positive expectation, even when told it's inactive, can trigger psychological and physiological responses, including changes in brain activity and stress regulation. This emerging evidence is reshaping how we think about mind-body interactions and the power of patient belief, opening up new ethical and therapeutic possibilities for managing symptoms without active medication.