Towards achieving transnational research partnership equity: lessons from implementing adaptive platform trials in low- and middle-income countries

Abstract

Background: Use of adaptive clinical trials, particularly adaptive platform trials, has grown exponentially in response to the coronavirus disease (COVID-19) pandemic. Implementation of these trials in low- and middle-income countries (LMICs) has been fostered through the formation or modification of transnational research partnerships, typically between research groups from LMICs and high-income countries (HICs). While these partnerships are important to promote collaboration and overcome the structural and economic disadvantages faced by LMIC health researchers, it is critical to focus attention on the multiple dimensions of partnership equity. Methods: Based on informal literature reviews and meetings with leaders of one of the multinational COVID-19 adaptive platform trials, we describe what can be learned about research partnership equity from these experiences. Results: We organize these considerations into eight thematic categories: 1) epistemic structures, 2) funding, 3) ethics oversight, 4) regulatory oversight, 5) leadership, 6) post-trial access to interventions, data, and specimens, 7) knowledge translation, and 8) research capacity strengthening and maintenance. Within each category we review the normative claims that support its relevance to research partnership equity followed by discussion of how adaptive platform trials highlight new dimensions, considerations, or challenges. Conclusion: These observations provide insight into procedural and substantive equity-building measures within transnational global health research partnerships more broadly.

Ethical priorities for international collaborative adaptive platform trials for public health emergencies

“…Funding such major networks inevitably involves opportunity costs—for other kinds of research, and for research institutions not involved in those networks. Here, and in the five WHO-commissioned reviews,2 9–12 we draw attention to how all parts of the research ecosystem need to keep in view these key ethical questions of power, equity and respect for local contexts and needs, as they take forward these effective models of research.…”

“…The success of adaptive platform trial designs in responding to COVID-19, and the endorsement by the WHA of major clinical trial networks, highlights the need to review experience to date so that trials can be conducted even quicker and better in future emergencies: driven by scientific rigour, and underpinned by sound ethical practice. Drawing on five reviews commissioned by the WHO Health Ethics and Governance Unit,2 9–12 that subsequently formed the basis for an expert round table held in Geneva in July 2022, we offer the following ethics-related key considerations to support the further development of international collaborative adaptive platform trials. Priority questions for future research and practice identified at the round table are set out in box 1.…”

Mentorship as an overlooked dimension of research capacity strengthening: how to embed value-driven practices in global health

“…Modlin et al have defined the eight dimensions of equity in global health partnerships specific to clinical trials. 40 These are: epistemic structures, funding, ethics oversight, regulatory oversight, post-trial access, knowledge translation and research capacity strengthening and maintenance. The challenge is how to create measurable indicators for partnerships to be able to assess progress and effectiveness against specific dimensions for different research collaborations outside of the clinical trials setting.…”

Understanding Heterogeneity in Acute Care Trials: Resource Availability Impacts Outcomes

“…Barriers to conducting research in LMICs include a shortage of financial and human capacity, difficulties navigating ethical and regulatory systems, limited preexisting research infrastructure, and competing demands on the part of healthcare systems ( 15 ). To overcome these barriers, potentially helpful actions include increasing the diversity of editorial boards ( 16 ); facilitating international collaboration within and across trials using harmonized protocols or platform, basket, and umbrella trial structures ( 17 ); ensuring equitable collaboration between HIC and LMIC researchers ( 18 ); integrating clinical trials with robust data collection and reporting systems ( 3 ); and empowering clinical research networks in resource-limited settings in the global south.…”