Universal standards for clinical trials
Posted by Ilona van den Brink on 18 October 2009 at 14:04
By Ochieng’ Ogodo
Good Clinical Practice (GCP) provides globally applicable standards for the conduct of medical research on pharmaceutical products on human subjects, reminds Raffaella Ravinetto, Head of the Clinical Trials Unit, Institute of Tropical Medicine in Belgium. The implementation of GCP in non-commercial research carried out in resource-constrained settings was one of the prime issues for the satellite meeting Universal standards for clinical practice that took place on Monday 12 October.
Compliance with GCP gives public assurance that the rights, safety, and well-being of research subjects are protected and respected, consistent with the principles in the Declaration of Helsinki and other internationally recognised ethical guidelines. It also ensures the integrity of clinical research data.
Currently, she said, we observe that the number of clinical research projects in developing countries have significantly increased over time thanks to, among others, the increasing number of externally-funded research programmes addressing the health problems of vulnerable populations.
Facing Challenges
Researchers working in externally-funded programmes in developing countries face the challenge of securing sufficient and sustainable funds to carry out trials that meet the appropriate ethical and scientific standards to ensure protection of people and quality of data.
“In addition, they are often confronted with the need to adapt practices and tools to the different contexts, without compromising on essential principles. The capacity to distinguish between essential versus non-essential requirements is therefore crucial in resource-constrained settings and programmes,” she said.
Ravinetto said some major challenges met when carrying out clinical research in resource-limited contexts, such as in sub-Saharan Africa, are represented by contextual constraints like difficult Internet connection and unavailability of local insurance companies for the no-fault policy insurance, but also by the weakness of the ethical review and by the vulnerability of potential trials subjects. For instance, the lack of access to adequate health care may limit the free decision-making on participation in research.
WHO and ICH Guidelines
Ravinetto reminded that the World Health Organization (WHO) published its Guidelines for Good Clinical Practice (GCP) in 1995, while the GCP Guidelines of the International Conference on Harmonization (ICH) were issued in 1996.
The principles and standards set in both guidelines are universal, but their implementation can be challenging in resource-constrained settings and in insufficiently regulated contexts.
That’s why the workshop will focused in particular on aspects which are relevant to the protection of people recruited in clinical trials in the South: double ethical review, challenges of “free and informed” consent in vulnerable populations, and the need to avoid any North-South ethical divide when Northern organisations sponsor research in developing countries.
South-South collaboration and EDCTP
Ravinetto said EDCTP represents an ideal platform for addressing these outstanding topics, for instance by sharing experience, by building common “good practices” like on informed consent and trials insurance, among others, and by encouraging the South-South and South-North collaboration among Ethics Committees.
She said the Switching the Pole Clinical Research Strategic Network shares with EDCTP the aim of jointly developing capacity, tools and procedures to apply universal standards for clinical research in resource-poor settings, and to transfer not only expertise but also resources and decision-making to the South.
“We are confident that the Forum will allow us to have a comprehensive analysis of the challenges that are still open, and to work together at finding effective solutions,” said Ravinetto.
Filed Under: Cross-cutting issues, Monday
