Today, HIV is increasingly being considered as a chronic condition with near-normal life-expectancy. Consequently, the well-being and health-related quality of life of people living with HIV are gaining increasing importance. Evidence suggests that even with effective treatment, people living with HIV have a significantly lower quality of life than the general population.
Reasons for this are grounded in the physical, psychological and social domains that are likely to be overseen by traditional clinical measures focusing mainly on viral load suppression, that determine the choice of treatment and drive the development of new drugs. Patient Reported Outcomes (PROs) can be a tool to address this issue. Defined as “data reported directly by a patient on his or her own health condition, without interpretation by a doctor or anyone else”, PROs can help assessing the implications of a disease and the applied treatment on how the patient feels and functions and comparing the clinical outcome to what the patient expects from the treatment.
Therefore, PROs and the corresponding Patient Reported Outcome Measures (PROMs), usually in form of standardized questionnaires, constitute a unique means of capturing the personal and social context of the patient’s experience in terms of the disease and treatment that might not necessarily be captured by biomarker4 measures or adverse events.
The overall goal of the project is to establish a joint framework for the consideration of HIV-specific Patient Reported Outcome Measures (PROMs) in HIV R&D in collaboration with key stakeholders from community organizations, academia, industry, regulators and Health Technology Assessment (HTA) bodies. The framework will provide guidance to the stakeholders involved in the field of HIV R&D on to what extent the currently used PROMs reflect the quality of life related needs and priorities of people living with HIV and to what extent the development of new HIV-specific PROMs is necessary. Furthermore, the framework will provide guidance for the involvement of patient representatives in all stages of the development process of new HIV-specific PROMs.
The project is mainly addressed to 1) community organizations and people living with HIV advocating for stronger consideration of quality of life aspects in HIV R&D, treatment and care; 2) industry, academia or research institutions working in the field of HIV R&D; 3) researchers and clinicians developing PROMs; 4) regulatory agencies in charge of drug approval and registration at European level (EMA) and at national level; 5) international organizations and institutions working in the HIV response in the WHO Europe region; 6) health policy decision-makers at EU level and national level; and 6) Health Technology Assessment bodies.
Project activities include:
|EATG contact person(s):||Fiona Greenhalgh – firstname.lastname@example.org|
|Duration of the project/initiative:||February 2020 – ongoing|
|Project/initiative Main Partner(s):||n/a|
|Budget:||2020: 10.000 €, 2021: 50,000 €|
|Main Funding Sources:||Merck Sharp and Dohme (MSD)|
|Communication Disclaimer:||This initiative has been independently developed by EATG and is supported by a grant from Merck, Sharp & Dohme.|
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