#5 / How do we engage communities to vaccine clinical trials?

Community engagement in RBDCOV

EATG leads the community engagement work package within the RBDCOV consortium. Stemming from our experience, we have contributed to the study design, protocols and other key documentation of the RBDCOV clinical trials, and we engage with our members and other communities of people living with immunocompromising conditions, key populations included in the RBDCOV trials.

Our main tasks are:

  • Running a Community Advisory Panel (CAP) that follows up on all aspects of the project and provides reviews of trial documentation including study protocols, advice to researchers and partners from the other work packages, as well as reporting to relevant communities.
  • Implementing the psychosocial study to understand and document the experience of participants of the vaccine trials.
  • Ensuring that language and content are accessible, community-friendly and tailored to the participants’ and laypersons’ needs. And we are determined to think outside of the box when it comes to engaging communities, as we did by creating a comic targeted to younger participants – and ultimately to all!

A little history – ‘Nothing about us without us’

‘Nothing about us without us’ has been a hard-earned motto for the communities affected by HIV/AIDS; one that has empowered people living with and affected by HIV/AIDS to fight for visibility and a space at the centre of the HIV response. Words and language have been the tools that our communities have used at times and at other times have contested to make a case for their lives via activism and advocacy. Community activism has come a long way since terms such as ‘victims’ and ‘patients’ were challenged with the declaration of the Denver Principles (1983). This reformed along the way into the ask and practice of Greater and Meaningful Involvement of People Living with HIV. For more than forty years, the communities of ‘HIV/AIDS patients’ have been there, first asking for expedited access to treatments when the condition was terminal and since then, advocating for better treatments with less adverse effects for quality living with a chronic condition.

Patients at the centre

This space for patients at the centre of the response is not granted only on the merit of real-life first-hand experience. The resilience of our communities was not only built on our will to fight silence, but also on realising the need and the having the will to learn the science behind the life-saving medicines to fight the virus. The story of our communities was one of a prolonged formation into expert patients. HIV/AIDS was the starting point for patient engagement and community advocacy models to come into other disease areas. Today, the role of patients as experts is recognised more and more as an indispensable component of research and development (R&D) and implementation science.

What does EATG bring to the table?

Since 1992, the European AIDS Treatment Group (EATG) has been at the forefront of patient advocacy, bringing together activists from across Europe and Central Asia. Treatment literacy and engagement in R&D have been priority areas for EATG. For more than 25 years, the European Community Advisory Board (ECAB) has been a space for community-led dialogue with pharmaceutical industry and academia. The ECAB model and learnings from it have been consolidated within European consortia like EUPATI and PARADIGM. In addition, ECAB constituted the Sitges Meetings, a multistakeholder initiative that pushed forward the need for and the science behind the cure of hepatitis C.

The expert input from our communities, within a supportive scheme such as the ECAB, benefits research and development for medicines, medical devices, and vaccines in various ways, such as:

  • An ongoing dialogue: within ECAB and under confidentiality, community members get involved in design and follow-up of clinical trials from initial trial phases to post-marketing. They monitor results of ongoing trials, and they often signal issues and suggest adjustments for the benefit of end users.
  • Protocol reviews: community experts carry out reviews of clinical trial protocols. This is a meaningful way to engage the community early on and ensure the quality and appropriateness of the study endpoints as well as effectiveness in real life.
  • Language and representation: community experts will highlight issues on the language of the trial’s protocol as well as the representativeness of the sample that is chosen. One of the recurring issues is the way participants of a trial are addressed – community advocates for the use of a neutral term such as ‘participant’ instead of ‘subject’ or ‘patient’. Furthermore, community aims to ensure participants come from the communities and represent the demographics that will finally benefit from the medicine. Convenience sampling (recruiting trial participants based on location, for example) often hinders the participation of people with compromised health or those with perceived lack of adherence to the interventions.
  • Expert patient vs lay patient: delivering the results of a clinical trial to its participants is sometimes overlooked or done insufficiently. Community experts, in collaboration with researchers, are the gatekeepers who will ensure that the information reaches lay participants and that it is in a format and language that is easy to understand. In addition, as lay language summaries have become mandatory with the EU Clinical Trials Regulation (CTR No 536/2014), expert patients can provide the key channels through which lay summaries reach laypersons, such as the communities who will benefit from the treatment in development.

This specialised article was authored by Apostolos Kalogiannis, Communications Manager of EATG and member of the RBDCOV Community Advisory Panel (CAP)