Participants at the first meeting of the Working Group, Geneva, 20-21 November 2017
WG Member area: to access the Working Group documents please click this link.
Clinical Research in Resource-Limited Settings
The burden of disease in countries with limited resources is undergoing major shifts. In addition to a high level of infectious diseases (compounded by emerging antimicrobial resistance), there has been a dramatic increase of non-communicable diseases. In addition, RLS are also seriously impacted by epidemic outbreaks of new transmissible diseases. This has triggered much attention towards developing new medical products to prevent and treat these diseases.
Historically, the efficacy and safety of new medicinal products have been assessed in well-resourced countries where the conditions and capabilities are appropriate to do so. As many new products are now to be introduced initially or exclusively in resource-limited settings, there is an increasing need for “local” clinical trials in conditions that may be less than ideal. This creates enormous challenges for the research community, product developers, donors, and the relevant national health and medical products regulatory authorities.
Working Group objectives
In November 2017, CIOMS launched a Working Group to address the present challenges and opportunities for clinical research in resource-limited Settings (RLS). This Working Group is composed of participants from academia, regulators, public-private partnerships for product development and industry partners.
The group aims to develop a consensus on relevant scientific issues and propose pragmatic recommendations for improvement of the environment and good practices for social acceptance, planning, assessing, performing and interpreting randomized controlled clinical trials in RLS.
Some of the challenges which CIOMS believes would benefit from further practical guidance and advice include: (1) creating awareness among the general public in RLS about the social and health value of the research; (2) avoiding delays in conducting clinical research for new safe and effective diagnostics, vaccines and medicines to treat emergencies, (3) creating an enabling and conducive environment for ethical and scientifically sound clinical research including randomized controlled trials (RCT) in RLS, (4) building new e-health records and registries in a way that they could also be used effectively for carrying out clinical research, and (5) defining requirements for local clinical trials.
- 1st meeting held on 20-21 November 2017, Geneva, Switzerland (minutes)
- 2nd meeting held on 27-28 March 2018, Geneva, Switzerland (minutes)
- 3rd meeting held on 8-9 October 2018, Tallinn, Estonia (minutes)
Open pre-meeting, 8 October 2018 a.m.: “Using electronic health records (EHR) for clinical research: can we do better?” (Agenda, with links to pre-meeting presentations)
- 4th meeting to be held on 27-28 February 2019
CIOMS Working Groups usually take 2-4 years to finalize their guidance and recommendations. Most groups hold two in-person meetings per year, with telework in between. The groups make use of collaborative efforts and capitalize on existing initiatives in order to provide output that is as comprehensive as possible, does not duplicate other efforts and has added value.
15 - 16 May 2019
5th meeting of Drug-induced Liver Injury Working Group
01 - 02 May 2019
3rd Meeting Working Group XI Patient Involvement in Developmnt/Safe Use Medicines
02 - 03 April 2019
15th Meeting of the Implementation Working Group on MedDRA
27 - 28 February 2019