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EFPIA report published on the value assessment of data disclosure
Recently, Lygature was asked by EFPIA to perform an impact assessment of current clinical data disclosure activities on public health. Following up on that request, our colleagues Pieter Stolk and Sophie Huiskes-Berends produced a report titled: ‘A landscape analysis for responsible transparency and clinical data disclosure for interventional studies in Europe and beyond’. The report has now been published on the EFPIA website.
The report examines the perceived public health value of various mandatory and voluntary disclosure venues. A mixed methods approach, including literature review, surveys, and interviews with stakeholders from academia, industry, and NGOs, was used. The findings reveal that that there is currently a focus on the initial stages of data sharing (e.g., number of requests), but the understanding of the broader public health impacts of these efforts is limited. Voluntary venues report some metrics, but they primarily measure outputs rather than actual public health impacts. In contrast, mandatory venues lack systematic reporting on public health indicators.
Stakeholders should work towards an agreed set of indicators that measure the value of disclosure efforts
The report highlights the need for collective efforts to create standardized indicators that assess the value of disclosure activities. It suggests tracking a cohort of data requests to better understand the impact of transparency on public health, which could enhance clinical data transparency and contribute to public health advancements.