Good Participatory Practice

What is Good Participatory Practice for Emerging Pathogens?

Good Participatory Practice for Emerging Pathogens (GPP-EP): a principle-based approach to effectively engage stakeholders in the design and conduct of prevention and treatment trials for emerging and re-emerging pathogens.

Clinical trials of medical countermeasures for new emerging pathogens produce significant breakthroughs in discovering lifesaving medicines, diagnostics, and vaccines during public health emergencies.  These trials are delivered in tough emergency contexts with accelerated timelines to produce results as quickly as possible. Multistakeholder engagement throughout the lifecycles of clinal trial development, deployment and dissemination ensures trial implementation is understood, acceptable, relevant, and trusted. Learning lessons from HIV prevention trials, in 2016, WHO developed guidelines for Good Participatory Practice to normalise and standardise this work for clinical trials of emerging pathogens (GPP-EP). 

Why implement GPP-EP?

GPP-EP emphasizes mutually beneficial, sustained relationships between trial sponsors, researcher teams, and other stakeholders throughout the life cycle of clinical trials conducted in a health emergency. It operates under the guiding principles of respect, fairness, integrity, transparency, accountability, and autonomy, and the benchmarks of this framework include mutual understanding, complementarity, and efficiency.

Benefits of GPP-EP

GPP applies across research types and settings and at all stages of research. Benefits of delivering effective GPP include:

• Enhanced acceptance  of research by multiple stakeholder
• Improved recruitment processes and participant experience of recruitment
• Contextualised and acceptable informed consent processes
• Physical or social risks (e.g. community or individual stigma) that may result from research participation can be anticipated and mitigated
• Potential alignment of research approach and outcomes with the stakeholder’s priorities.
• Empowers communities and demonstrates respect
• Strengthen mutual understanding, trust and credibility of researchers with implications for current and future research.

An example: GPP-EP for the Solidarity Trial Vaccines

GPP-EP activities are central to the Solidarity Trial Vaccines (STV), an international, multi center, multi vaccine, adaptive, shared placebo, event driven, individually randomized controlled clinical trial that aims to evaluate the efficacy and safety of promising new COVID-19 vaccines. The trial has recruited over 18 000 people and is delivered by national teams in the Philippines, Colombia and Mali, with new sites opening in Tanzania and Sierra Leone in 2022.

The STV is being delivered in a challenging and dynamic context. Trial sites face varied challenges related to emergence of new variants, changing public policy for COVID-19 control, differing impacts of these policies on lives and livelihoods, administrative restrictions, competing clinical trials, and availability of COVID-19 vaccines on national programmes. To share experience and best practice approaches to tackle these challenges, WHO facilitates a global coordination mechanism for all national teams. A suite of standard operating procedures, communication tools and materials are also available and these are rapidly adapted for new countries and sites that join the trial. These include:

• A handbook for GPP-EP with practical worksheets and templates to guide planning
• A handbook for Crisis Communication
• An illustrated FlipBook for standardised information exchange during trial recruitment
• Leaflets, a short trial animation and presentation materials
• An online learning programme introducing key concepts of GPP-EP and how to do it

Across all national teams, community engagement leads have been identified, and engagement teams have been set up and resourced to deliver GPP-EP activities. This work is done with stakeholder groups at multiple levels including policy makers, health ministries, local leaders, and local community members. Activities include community meetings, communication campaigns, and formative research to highlight ways in which trial delivery needs to be adapted in response to local needs and context. GPP-EP will continue throughout the trial and a parallel study is capturing experience and best practice from national teams to inform implementation for future scenarios and advance this important field.