Draft report: Joint CIOMS/WHO Drug Development Research in Resource-limited countries: How to succeed in implementation of Good Clinical Practice Guidelines
A round-table discussion was held on 30 November 2011 at WHO/HQ, Geneva, Switzerland discussing the option of revising/updating the above draft report. Experts from different regions were invited to discuss and give comments on this issue and specifically consider: 1) if the scope of the previous publication itself should be re-visited for potential needs of further elaboration to be addressed in a future updated document, 2) to identify potential users of the report, 3) to include pediatric and gender aspects, 4) to consider regulatory capacity in resource-limited settings and whether capacity building should be built into the document, 5) the globalization of health research/clinical trial and perhaps the lack of comprehensive regulatory framework, and 6) the need to incorporate a section on risk management plans and programs dedicated to certain diseases including examples.
Overlaps with other guidelines and documents were clearly noted during the meeting. The initial major intention of the document had been to clarify how ICH-GCP applies in settings in RLCs and how existing infrastructure fits into the GCP guidelines.
Based on the outcome of the round-table discussion CIOMS, in collaboration with WHO, has decided to focus on the update of ethical aspects relating to clinical research in resource-limited settings which is addressed in the draft report and incorporates this in the planned review procedure of the 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects. The draft report as such will continue to be available on the CIOMS website notifying that this was the result of previous work ending in a publication in December 2005.
The Core Group published the results of its work in December 2005 as a draft document which was posted on the CIOMS website for comment. WHO is collecting comments from its Member States via its Regional Offices. Many endemic diseases appear only in developing countries and the development of safe and effective treatments requires clinical trials to be conducted in these countries. There is also a need to develop responsible and operative systems for pharmacovigilance in resource-poor countries to address the efficient collection and assessment of drug safety data from clinical trials during drug development, and to assure the reporting and surveillance of drug safety in the post-authorization phase when the product is used in local treatment settings. Many obstacles and barriers to clinical trials need special consideration and appropriate solutions in resource-poor countries.
CIOMS established a Core Group on this topic in 2004 and members included scientists from WHO, national/academic research institutions in resource-poor countries and the pharmaceutical industry.