As a patient- and community-led NGO, EATG has been a leading actor in advocating for the rights and interests of people living with or affected by HIV/ AIDS and related co-infections within the WHO Europe region since 1992. EATG established the European Community Advisory Board (ECAB) in 1997 as a forum for interaction between the community of people living with HIV and AIDS and the pharmaceutical industry to receive information on research / medicines in the pipeline, discuss trial designs and marketing strategies and provide the community and participant perspective. EATG has since been replicating this community advisory model for many years in European projects, such as RBDCOV.
Let us meet Bogdan Hadarag, EATG member since 2016, advocate from Romania and one of the members of the EATG Community Advisory Panel (CAP) for the RBDCOV Project.
- Thank you for accepting this interview invitation, Bogdan. Could you please introduce yourself and tell us a bit about yourself and your role in the RBDCOV project?
I am Bogdan Hadarag and as member of EATG, I have been advocating for fast and easy access to reliable treatment and healthcare services for people living with HIV. My experience in clinical trials and R&D started when I joined the EATG in 2016. I got to participate in lively discussions with stakeholders from pharmaceutical companies on development and access to the latest treatment for people living with HIV through the European Community Advisory Board (ECAB). Thanks to this experience, I was able to be part of the EATG Community Advisory Panel (CAP) for RBDCOV and bring my expertise into this project. Indeed, with 7 other EATG members, we review RBDCOV clinical trial documentation from the perspective of the HIV community, participant’s involvement in the trial and the communication of the project activity to our community and the larger population.
- In your own words, what do you think are the barriers that the community faces in relation to meaningful engagement and involvement in these types of European projects on medicine or vaccine development?
Although the types of barriers differ from country to country, some of the causes for low participation in clinical trials are related to stigma and discrimination, which make people living with HIV less confident to disclose their status for fear that the information may be further shared. On top of that, access to information about the process of clinical trials is still reserved to the ‘scientific elite,’ such as doctors and researchers, and the language of clinical trials is often highly technical and very intimidating.
On the broader scheme of things, there are factors that raise additional barriers to whoever is potentially interested to get involved in clinical trials. One of them, for instance, is the lack of a national and international framework in which the community of people living with HIV, for example, can work together with medical and research stakeholders on what matters in a clinical trial. This cuts off the research community from vital input provided by participants with regards to the outcome of a newly developed treatment.
On top of that, oftentimes European-sponsored projects on medicine or vaccine development are considered overly complicated and although their standards are of the highest level, their complexity can often seem daunting and intimidating to the community. This may be a loss for both the research and patient communities.
Finally, we should acknowledge that the overwhelming majority of information about clinical trials is published and presented in English., which might represent a significant barrier for non-English speakers. As a consequence, sources of information on this subject tend to be extremely sparse in other languages, making access to clinical information exclusive to medical specialists.
- EATG has recently published a position paper on the importance of including people living with HIV in non-HIV clinical trials. In your opinion, what are the consequences of not including people living with HIV in clinical trials similar to the RBDCOV trial on a new COVID vaccine?
The COVID-19 pandemic showed that people living with HIV were excluded from COVID vaccine trials, despite being among the populations that are most vulnerable to the virus. The consequence was that the HIV community received a vaccine that was solely tested on a “healthy” population, which implies the standards to test vaccine efficacy on people living with HIV were extremely low: no studies on vaccine efficacy for people living with HIV were conducted during the first months of the pandemic, and no risk assessment standards were implemented either. Fortunately, the vaccine did prove to be efficient for people living with HIV as well. However, unlike the “healthy” population, our community participated in a situation that resembled a non-controlled vaccine trial, as opposed to a standard, clinical one.
One of the biggest problems with modern clinical trials is that the population that takes part in trials is not truly representative of the population that will use the study treatment, if approved for commercialisation. This lack of inclusion means that a treatment is not tested on people with a whole set of comorbidities, including people living with HIV. This becomes even more problematic for the ageing population.
- Finally, what would your recommendations be to ensure the effective inclusion of the community in projects such as RBDCOV?
I believe that the RBDCOV project sets out a good example of multilevel cooperation, where EATG, representing the patient community, plays an essential role in ensuring that all the communications and information on the clinical trials are accurate, understandable and accessible to both the patient communities and general population. Following this example, I encourage community to advocate more for the trial sponsors and regulators to consider a participant cohort in clinical trials that is fully representative of the specificities of different patient communities, emphasising how important it is to focus on people with overlapping conditions. At the same time, I believe it is essential that as many people living with HIV as possible fully understand the significance of their participation in clinical trials. If we all do, it would then be easier to convince the other stakeholders that the design of non-HIV clinical trials needs to be improved to include people living with HIV.
