Author: Lisa Power, consultant EATG

Community Advisory Boards, both in-country and Europe-wide, are a feature of patient engagement (PE) in the R&D process for a growing number of health conditions. Patient advocates from across Europe meet with companies and researchers to inform the drug development pathway about real-life impacts and improve information flow to their communities. The European AIDS Treatment Group (EATG)’s European Community Advisory Board (ECAB) has been working for over two decades now on HIV and, more recently, drug development and access issues for viral hepatitis and tuberculosis. I spoke to members of the ECAB, as well as the Scientific Officer about their experiences from the early days when anyone could attend the ECAB to the current, more systematic and orderly structure.

How did you come to be involved in ECAB?

Wim Vandevelde (Portugal): “I joined just after combination therapy breakthroughs… we had some rowdy meetings. There were often clashes about access to new drugs and pricing issues.”

David Haerry (Switzerland): “I was already an experienced patient advocate when I joined in 2004. I was really impressed by the quality of the discussion at ECAB”.

Giulio Maria Corbelli (Italy): “When I joined in 2009 I couldn’t understand the language or the science. But I was interested, I kept trying; eventually, I even became the Chair”

Memory Sachikonye (UK): “In 2011 I was invited as a guest through other UK members who knew my work. It’s important to bring women and minorities into CABs for a range of insights.”

Alex Schneider (Russia): “I joined in 2018. We have a similar CAB just for Eastern Europe but the ECAB is much more focussed on clinical trials, PROMS and patient engagement work.”

Giorgio Barbareschi (Belgium): “I’m the current EATG Scientific Officer and have been involved in making a lot of changes to our format. The science and treatments change and so must we.”

Community Advisory Boards can give vital input to drug development. Tell us about a time when ECAB made a clear impact on research proposals?

David: “In 1997 ECAB pushed for surrogate markers to be used in HIV trials instead of clinical endpoints, which meant death. We proposed using CD4 counts to establish effectiveness, and the EMA agreed with us. This hastened the drug approval process and benefited everybody. And in 2006, many people were worried about accumulated multi-drug resistance. It was difficult to persuade companies to share research, but one company with compounds in different classes but at the same stage of development agreed. We helped to convince the regulators that this would be a useful trial – and it was. Multi-drug resistance was dramatically reduced in Western Europe and North America within a couple of years.”

Memory: “We pushed hard about involving women in trials more and doing research specifically with us.  We just kept questioning protocols and bringing the issue up. Eventually, it happened with Women AntiretroViral Efficacy and Safety (WAVES) study and then others followed. There are women-specific issues in drug development and we needed to be involved.”

Giorgio: “Following a gap analysis to define new needs, we drove a discussion on patient-focused outcome measures, making proposals to companies for this. It has helped to move the focus away from purely clinical indicators to other markers for comparing new drugs and we are now working with industry on this.”

From your experiences, what can hinder the effectiveness of a CAB?

Giulio: “The worst thing is to argue in front of a company; always have an advance discussion because in-fighting can derail a meeting.”

Giorgio: “If the model becomes repetitive, it’s no help to either party. We found it important to increase the capacity of members and channel them into smaller groups where they have focussed expertise on specific topics.”

David: “We didn’t react to PrEP fast enough (pre-exposure prophylaxis to prevent HIV transmission) because we found it hard to change our attitudes and see that treatments could work for prevention. We were too suspicious that it was all about profit when it was also life-saving.”

Do you have suggestions for how PE could work better, based on these experiences?

Giulio: ”The most important thing is preparation – impose your presence on the development pathway. It’s hard for volunteers but we need to raise questions and chase up answers.”

Wim: “With good preparation, the people consulting us can’t just pick out the answers they like and ignore the rest. You can ask companies to provide questions in advance of meetings because this allows people to share knowledge and come to a consensus if possible.”

David: “It’s important to regularly review the group’s performance, both with the members and with the other stakeholders.”

Memory: “Don’t be a tick box for diversity – make your voice heard. Tell people, if you don’t understand, ask someone. Get people to talk in terms you can understand.”

Alex: “It’s important to have people from right across WHO Europe contributing, because the issues differ so much; in the East, access is central; science alone is like a fairytale unless you can access the results.” In this, Alex echoes Wim’s description of the early days of the ECAB for the Western European activists in the 1990s.

Giorgio: The science changes and we must change with it. For us, vaccination and cure programmes are now a possibility and new topics need new knowledge.”

Continuous development of scientific knowledge was emphasised repeatedly by the respondents. EATG holds annual training courses and webinars. Recently, working with the UK’s African Advocacy Foundation, they ran a highly successful course solely for migrants.

What more can CABs do to ensure the involvement of all affected key groups?

Memory: “Hook people when they’re newly diagnosed and develop their expertise, train them! I was supported by other UK activists to get involved. Realise when the conversation is being dominated by one group. It’s important to speak up, there’s no point being the only woman or black person in the room if you’re not being heard. ”

Giorgio: “Introducing a thematic approach to working with companies and research bodies has enabled us to involve more people on the areas that are most important to them. Doing a gap analysis enabled us to examine what and who was missing and get everyone’s input. On top of working directly with companies, we now also work on a smaller scale with EU-funded academic-led research projects to help them design focussed trials and think through ethics issues.”

What is the difference between PE on a national and European-wide basis?

Memory: “ECABs have the advantage of wider and more diverse experiences, and we can share our experiences with people from other countries where activism is more recent.”

David: “Shared knowledge across Europe can help in-country advocacy as often health conditions, particularly transmissible ones, can be different in who they affect and how they are managed. ECABs need to concentrate on science, but they can also convey high-level access issues in a structured overview to companies.”

Alex: “Countries with access problems can talk to their local company people, but at a European level we meet people who are higher up. We need the support of Western advocates to help us press these issues.”

Giulio: “You can’t just hang out with the companies and researchers at the top level. For an ECAB to be useful in helping to shape drug developments you must also stay connected to your community and be able to represent the range of their needs and concerns.”

The ECAB continues to develop and adapt to the rapid changes in HIV drug discovery, development and technology. It has gone from a “rowdy” meeting of mostly untrained activists to a highly expert and increasingly diverse body of knowledge, working closely with industry, academia and other stakeholders. It also increasingly works with other patient bodies on a European-wide level to share insights and, as in PARADIGM, develop new tools and improved methods of engagement for the benefit of all stakeholders.