This paper seeks to clarify where EATG stands in the debate advocating against the systematic exclusion of people living with HIV and for their increased participation in non-HIV clinical trials. The inclusion and exclusion criteria for the 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.
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 non-HIV-related investigational drugs, which results in a lack of safety and efficacy data, can limit the access to appropriate healthcare and lead to results that do not represent treatment effects in the patient population that will ultimately use the drug. Patients, researchers and research sponsors acknowledge that patients should be actively involved in the design, conduct and dissemination of clinical research, as this is essential for patient empowerment, it gives patients a sense of control over healthcare decisions and it benefits all stages of clinical investigation and product development.
Therefore, EATG aims to support the development and implementation of inclusive clinical research guidelines toward improving health outcomes for people living with HIV and other comorbidities and advocate that more inclusive eligibility criteria are adopted by European countries and regulated by national and supranational regulatory agencies. In addition, EATG aims to contribute to discussions in Europe and elsewhere towards the revision of Good Clinical Practice Guidelines and inspire all people living with a health condition to fight for their right to be part of clinical research whose outcomes may benefit their treatment and care.
Specifically, EATG recommends that stakeholders:
This position paper was produced in the frame of the BELONG Project. Additional information on the project is available here.
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