The Inclusion/exclusion criteria for participation of people living with HIV in non-HIV clinical research has been an ongoing discussion, exacerbated by recent COVID-19 vaccination trials, which initially excluded people living with HIV. Exclusion criteria are based on clear scientific or clinical rationale which are non-negotiable in clinical trials, and there is concern from the HIV community that the ongoing cases of restrictive eligibility criteria without such rationale, often applies to people living with HIV.
As pointed out by the FDA, this may “limit patients’ access to clinical trials and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug” (FDA Guidance on Cancer Clinical Trial Eligibility Criteria). HIV is now considered a chronic and manageable condition when appropriate treatment is available, so the rationale to exclude people living with HIV, based solely on their HIV status is lacking. Yet, this is often common practice in most studies of investigational drugs.
The overall goal of this advocacy project is to produce a position paper that advocates for the inclusion of people living with (as suggested by the FDA) HIV in clinical research to be mirrored by European countries and regulated by the EMA, not only for cancer trials, but also for other disease areas.
The project will be implemented in close collaboration with the EATG Partners In Science Programme Committee and an ad-hoc Advisory Group composed of seven EATG members (Alain Volny-Anne, Axel Vaderperre, Brian West, Daniela Rojas Castro, Luís Mendão, Memory Sachikonye, Sean Hosein).
The main activity of the project will be the drafting of an advocacy position paper that will include:
With this advocacy position paper EATG aims to:
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