Clinical Research in Resource-Limited Settings

Above: Participants at the first meeting of the Working Group; Geneva, 20-21 November 2017

Background

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, resource-limited settings (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 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.

Progress

• 1st meeting held on 20-21 November 2017 in Geneva, Switzerland (minutes)
• 2nd meeting held on 27-28 March 2018 in Geneva, Switzerland (minutes)
• 3rd meeting held on 8-9 October 2018 in Tallinn, Estonia (minutes)
  The 3rd WG meeting was preceded by an Open meeting on “Using electronic health records (EHR) for clinical research: can we do better?” (Agenda, with links to presentations)
• 4th meeting held on 27-28 February 2019 in Geneva, Switzerland (minutes)
• 5th meeting held on 8-9 October 2019 in Mérida, Spain (minutes)
  The 5th WG meeting was held in conjunction with the RIBEF-CIOMS Symposium on medicines and health in autochthonous populations of Latin America.
• 6th meeting held on 22 April 2020 on a virtual platform (minutes)
• 7th meeting held on 22 June 2020 on a virtual platform (minutes)
• 8th meeting held on 20-21 August 2020 on a virtual platform (minutes)

From end of August 2020 eight Working Group members, supported by the CIOMS Secretariat, collaborated as an editorial group to develop the draft report further. The editorial group held ten virtual meetings, with telework in between.

On 15 March 2021 the draft report was posted for public comment. The comment period closed on 19 April 2021.

The Working Group report was published in June 2021.

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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.