Clinical Research in Resource-limited Settings
In November 2017, CIOMS launched a Working Group (WG) composed of key stakeholders including academia, regulators, public-private partnerships for product development and industry partners to address the present challenges and opportunities for clinical research in Resource Limited Settings (RLS). This WG 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. Furthermore, collaborative efforts aimed at capitalizing on existing initiatives/ documents will also be part of the WG in order to provide output that is as comprehensive as possible, does not duplicate other efforts and has added value.
It is recognised that countries with limited resources are undergoing changes in the disease profile with a dramatic increase of non-communicable diseases while retaining a high level of persistent communicable/transmissible diseases (including the emergence of antimicrobial resistance) and while also being seriously impacted by epidemic outbreaks of new transmissible diseases. This has triggered much attention towards developing new medical products to address these needs. However, this response has also created enormous challenges for the research community, the product developers, donor community, and last but not least, for the relevant national health and medical products regulatory authorities
While the clinical evaluation of efficacy and safety of medicinal products to address these needs is generally assessed where the conditions and capabilities are appropriate to do so, it is also clear that there are many instances when these assessments must be expanded to include situations where the conditions may not be ideal, particularly when local factors may question their medical value raising the issue of the need for “local” clinical trials.
Some of the challenges which CIOMS believes would benefit from further practical guidance and advice include awareness among the general public in RLS about the social and health value of the research are: (1) delays in getting clinical research going for new safe and effective diagnostics, vaccines and medicines to treat emergencies, (2) creating an enabling and conducive environment for ethical and scientifically solid clinical research including Randomized Controlled Trials (RCT) in RLS, (3) building new e-health records and registries in a way that they could effectively also be used for carrying out clinical research, and (4) requirements for local clinical trials.
The first WG meeting took place 20-21 November in Geneva. It is anticipated that the WG will have two in person meetings per year and tele-work in between. Usually CIOMS WGs take 2-4 years to finalise their guidance and recommendations.
WG Member area: to access the Working Group documents please click this link.
11 - 13 April 2018
13th Meeting of the Implementation Working Group on MedDRA
27 - 28 March 2018