RBDCOV: It Starts and Ends with Us | Nothing About Us Without Us: The Power of Community in Transforming Clinical Research

In the early days of HIV treatment, patients were merely subjects of research, not participants in the process. We were not consulted. We were not heard. We were not included. And at that time, it was not just an abstract discussion about treatment, it was about survival. We needed a voice, especially when new and better drugs began to emerge. What did we want? What did easier treatment regimens mean? Less frequent dosing? Fewer side effects? No dietary restrictions? To be very honest, in the beginning, we had been willing to take any drugs that would save our lives. Now we wanted to concentrate on living. Quality of life became essential. And for that, we needed to be involved.

We started to engage in drug development. But at first, we were only brought in at the very end of the process. That had to change. We quickly recognised the critical need for patient involvement from the very beginning: in trial design, participant selection, and ensuring proper informed consent. That was our main objective and our main challenge; having the power and possibility to help set the agenda and influence decision-making processes. There are two good examples of when we managed to overcome these challenges. We wanted to set the agenda, not just respond to it.

Firstly, we successfully established a framework where pharmaceutical companies included us in reviewing study protocols and informed consent documents from the earliest stages. A practice that continues to this day. It was not easy, and it took many years of activism and perseverance. However, we did succeed in becoming involved from the earliest stages of drug development and research. But it took a while! It was not smooth sailing. One major pharmaceutical company took nearly a decade to embrace community involvement. Until 2018, this company, Gilead believed patient input had limited value. This is a stark reminder of the resistance we faced. What truly made the difference was our resilience, and our persistence. We never gave up.  The community kept pushing. Our message was clear: “Nothing about us, without us.”

Secondly, the Sitges meetings were also a turning point. While effective HIV treatments had been developed, more and more people were dying of other causes.  In many parts of Europe, many people living with HIV were co-infected with hepatitis C.  It was the viral hepatitis that was now putting their lives at risk and killing them. We knew new drugs were in development, but we asked: where were the people co-infected with HIV and hepatitis C in that process? Would they be included in the research? Would they have access to the new drugs once approved?

To address this, we brought together people living with HIV and hepatitis C, pharmaceutical companies, regulators, healthcare workers, and researchers. We all came together in Sitges, Catalonia, in a collaborative and respectful space. Together, we shared concerns and asserted our legitimate demands because early inclusion in phase 3 clinical trials being one of the most important. And we succeeded. When new treatments came to the market they had been tested on, and were now available, for people co-infected with hepatitis C.

So where does that leave us today? We now regularly conduct protocol reviews for pharmaceutical companies and EATG has a dedicated team for this important job. We also contribute to shaping patient-reported outcomes, ensuring that the lived experience is reflected in research and care.

However, there is an area where there is still so much work to do:  ensuring diversity, equity and inclusion (DEI) in clinical research. Too often, the people included in trials do not reflect the diversity of those affected by the diseases being studied. We need to do more to make sure the right communities are included in clinical research and drug development, so that treatments truly meet the needs of all who need them.

We are actively participating in projects that address these issues. Examples below:

• Belong –This EATG project advocates for regulatory authorities in Europe to adopt clinical guidelines that include people living with HIV in trials relating to other illnesses and health conditions that affect people living with HIV.
• READI– A large EU/ Innovative Health Initiative (IHI) funded project addressing research and similar challenges in underrepresented and underserved populations.

I believe that, to truly move forward, we must continue to be included, not just in HIV-related studies, but across all areas of clinical research. In areas, where we are at higher risk of illness such as cancer or cardiovascular disease. I also think that history and everything we have learnt in this journey can guide us well. Always making sure that the voices of the community are never left behind.

I’m confident that the future of clinical research is changing thanks to community-led advocacy and partnership working. We’ve come a long way, but the journey isn’t over. We’ll keep pushing for equity, representation, inclusion and respect.

Brian West

Member of the RBDCOV Community Advisory Panel and European AIDS Treatment Group, (EATG) and Chair of the EATG Partners in Science Programme.

He has been living with HIV for over 40 years.

This blog is part of the RBDCOV campaign ‘It Starts and Ends with Us’ 

The RBDCOV project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101046118

Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.