EDCTP Call for Proposals: Implementing adaptive platform trials

The European & Developing Countries Clinical Trials Partnership (EDCTP) on “Implementing adaptive platform trials” to support activities that are contributing to one or several of the expected impacts for this call. To that end, proposals under this topic should aim for delivering results that are contributing to all the following expected outcomes:

• More clinicians and researchers in sub-Saharan Africa have the capacity to design, implement and maintain large-scale, multi-centre and multi-country adaptive platform trials allowing the simultaneous evaluation of multiple interventions in an adaptive manner;
• A number of large-scale, multi-centre and multi-country adaptive platform trials, investigating treatments and/or treatment regimens for infectious diseases are implemented in sub-Saharan Africa, having the operational capability to rapidly include treatment approaches for infectious diseases outbreaks with epidemic or pandemic potential;
• Health care providers and professionals in sub-Saharan Africa have a better understanding on how to treat and reduce the burden of infectious diseases within the scope of the GH EDCTP3 programme in this call topic;
• Trial sites across multiple institutions and countries belong to a coordinated network of clinical sites and facilities such as research laboratories with the capacity to deliver efficiently robust clinical evidence derived from a diverse population, through harmonized research methods, data collection and sharing and joint analysis;
• More clinical investigators and researchers at the earlier stages of their career (e.g. Master’s, PhD candidates, or post-doctoral level), including increasing proportions of women scientists, are able to develop a scientific career in sub-Saharan Africa and establish themselves as scientific leaders in sub-Saharan Africa.

This topic aims to support the implementation of adaptive platform trials for the evaluation of candidate treatments for infectious diseases in sub-Saharan Africa. These trials should also be able to rapidly evaluate treatments in response to an emerging infectious disease threat.

The proposals should address all of the following:

• Implementation of adaptive platform trials in sub-Saharan Africa that are routinely evaluating treatment options for infectious diseases within the scope of this topic in ‘inter-epidemic’ times, while also considering in their trial design the ability to be ‘epidemic-fit’ and ready for the timely assessment of treatments in the face of an infectious diseases outbreak with epidemic or pandemic potential;
• Training on clinical trial implementation and laboratory analysis, harmonized data collection and management systems to run the adaptive platform trials and at the same time create a coordinated network of clinical trial sites and research laboratories for longer-term usability;
• Hurdles related to ethical, administrative, regulatory and logistical aspects should be addressed in order to allow smooth implementation of adaptive platform trials and avoid such barriers when the trial needs to adapt in response to an epidemic or pandemic;
• Outreach to sub-Saharan African clinical researchers and biostatisticians to build and increase the capacity for the design and implementation of further adaptive platform trials across sub–Saharan Africa;
• Promotion of close communication between clinical experts, patient communities, regulators, health care workers and policy makers to increase understanding of and trust in adaptive platform trials as an efficient design for clinical research in sub-Saharan Africa;
• Interaction with relevant national public health institutes, Africa CDC, World Health Organisation – Regional Office for Africa and/or other regional and international relevant organisations to adequately address health research systems needs in adaptive platform trial study design;
• Sex and gender aspects should be taken into account. All data should be disaggregated by sex, age and other relevant variables, such as by measures of socioeconomic status (i.e. take into account the socioeconomic gradient).

Read more here.

Proposals deadline August 30, 2022.