As technology and our understanding of patients continue to evolve, our approach to clinical trials must adapt too. As research professionals, we have a responsibility that goes beyond data collection.
This is why the International Council for Harmonisation (ICH) established the Good Clinical Practice (GCP) guidelines in 1996, and has now updated them with the latest ICH E6(R3), thereby creating a new global standard for ethical and scientific conduct in clinical research.
What is Good Clinical Practice (GCP)?
Good Clinical Practice (GCP) is a set of ethical and scientific quality standards that provide the framework for designing, conducting, recording, and reporting clinical trials.
It involves:
- Protecting Participants: The primary goal of GCP is to safeguard the rights and well-being of individuals participating in research. This means their interests must always take precedence over the interests of science and society.
- Ensuring Data Integrity: GCP also guarantees that the data collected from the trials is credible, accurate, and reliable. This is crucial for making informed decisions about the efficacy and safety of new medical products
The Evolution of GCP
E6 R3 introduces updates that reflect the significant changes in clinical research since the last revision. In a few years, we’ve seen the rise of digital tools, the growth of decentralized trials, and a stronger push for patient-centered approaches.
Rather than replacing everything we know, R3 builds on this progress and provides a clearer direction for how trials should be designed and conducted going forward.
- E6 R1 (1996) was the first harmonized set of GCP principles. It focused on ethics, participant rights, and safety, and set the foundation for how trials should be conducted.
- E6 R2 (2016): This version improved on R1 by adding risk-based monitoring and stronger data integrity measures. It also recognized the increasing importance of technology in clinical research.
- E6 R3 (2025) is the latest version. It is more flexible and focuses on the trial participants; it integrates quality into trial design from the beginning. It is structured around core principles and annexes, designed to adapt to a wide range of trial types and modern methodologies.
The International Council for Harmonisation (ICH) groups its guidelines into four categories:
- Quality (Q): ensures that manufacturers produce medicines safely and reliably. It focuses on stability, impurities, and Good Manufacturing Practices (GMP).
- Safety (S): Focuses on protecting people before drugs reach them. It includes studies on cancer risk, DNA damage, and reproductive safety.
- Efficacy (E): This covers how researchers test drugs on humans to prove they are effective.
- Multidisciplinary (M): it offers tools for all areas; it includes MedDRA for reporting side effects and electronic data standards.
The new ICH E6(R3) focuses on Efficacy. It strengthens GCP to protect participants and ensure reliable, high-quality data in trials.
Major Updates in ICH E6(R3) Good Clinical Practice Guidelines
Patient-Centered Approach
The ICH E6(R3) places a shared and clear responsibility on both sponsors and investigators to consider the participants’ comfort, burden, and well-being right from the design stage. It forces sponsors to think about the participant as a human being, not a concept to treat.
In some trials, participants may have to go through several procedures before they notice any results or benefit.
for example, blood samples might be collected from diffrerent part of the body,causing discomfort for someone that is already unwell.
The ICH E6(R3) emphasizes that participants should not be subjected to trials that leave their quality of life severely affected.
Quality by Design (QbD)
R3 introduces Quality by Design as a core principle. Sponsors need to embed quality througout the trial. This starts with defining the research question and continues with designing the study protocol till the last stage of the trial. This approach helps reduce risk, protect participants, and ensure ethical and scientific integrity.
Embracing Technology
R3 highly recommends using digital tools such as electronic informed consent (e-consent), electronic data capture (EDC), and remote monitoring, to improve the efficiency, strengthen data accuracy, transparency, and security, and reduce paperwork.
To ensure the results are trustworthy and auditable, the guideline provides a foundation of system validation, data governance, and accountability.
Scientific Validity
Well-planned protocols act as the “blueprint” for a study. A protocol should clearly state the research question and expected outcomes. It must focus on both efficacy and safety.
Trials need to be scientifically sound and follow clear, detailed protocols. This ensures that the results are valid, reproducible, and meaningful, giving confidence that the questions being answered are relevant and reliable.
Proportional Risk-Based Oversight
Not all trials carry the same level of risk. R3 emphasizes tailoring oversight to the actual risk of a study. An intervention trial requires more intensive monitoring than a simple observational study. This practical approach keeps resources aimed at what’s most important: participant safety and data integrity.
Impact of ICH E6(R3) on clinical research in Nigeria
For Nigeria, this revision is an opportunity to build a quality research ecosystem.
- Investing in Local Talent: Nigeria has a strong pool of research professionals. However, because of “Japa” syndrome, a lot of our talents now choose to seek training abroad. R3 highlights the urgency of investing in local capacity building, ensuring that our workforce can compete globally while contributing to homegrown research excellence.
- Culturally Relevant Research: Our genetics, diet, and lifestyle set us apart. Medicines designed based on data from Caucasian groups may not yield the same outcomes when used in African populations. We have different genetic makeups. R3 promotes local clinical trials that reflect our needs. This helps ensure that treatments are safe and effective for us.
- Digital Transformation: In Nigeria, we must move away from relying too much on paper-based systems and ensure our work is being documented electronically. This will help us access and use our data more effectively. With high mobile penetration, digital systems can streamline trials, improve transparency, and strengthen Nigeria’s global competitiveness in research.
- Regulatory Alignment: NAFDAC is now integrating ICH E6(R3) principles through training and workshops focused on key updates like data integrity and risk-based approaches. This prepares NAFDAC to align its oversight with the updated ICH guidelines. Doing so will streamline trial application processes and enhance confidence in Nigeria’s research outputs.
- Global Positioning: Nigeria can strengthen its global reputation by actively adopting and implementing the ICH E6(R3) guideline. Such alignment will not only attract more international trials, investment, and partnerships but also enhance our regulatory credibility and improve local healthcare outcomes
- Public Trust: Improved standards for safety and data reliability under R3 can enhance public confidence and increase participation in clinical trials.
Future of ICH E6(R3) in Clinical Trials
ICH E6(R3) is an invitation to raise the standard of clinical research. For Nigeria, it is a call to:
- Build capacity and keep talent locally.
- Embrace digital systems.
- Strengthen regulatory processes.
- Conduct research relevant to our people.
The journey requires collaboration across regulators, institutions, sponsors, CROs and research professionals. With R3, Nigeria has the chance to become a trusted global partner in clinical research.
To learn more about the ICH E6 R3 update, watch the full recording of our webinar on “Unpacking ICH E6 R3 and Its Impact on Clinical Research,” and join the conversation about shaping Nigeria’s future in this field.
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