Quality AssuranceClosed
TrackValue
Building clinical trial transparency at the Charité
TrackValue is a project of the Translational Partnership program between the Wellcome Trust and the Charité/BIH with two objectives: a) assess Charité’s performance on select metrics for responsible research (e.g., open access, data sharing) and communicate these assessments in an accessible and interactive format, and b) assess the impact of an intervention using trial-level report cards to increase clinical trial transparency at the Charité. In future work, we plan to build on this Charité-level pilot at and scale to further institutions.
Phase 1: Research institutions such as University Medical Centers (UMCs) play an important role in fostering responsible research practices by providing education, infrastructure, and support. However, UMCs face challenges fostering responsible research practices without information on current practice highlighting where there is room for change and where to focus improvement efforts. We performed a status quo analysis of select practices for responsible research at the Charité and developed a dashboard to communicate these baseline assessments with UMC leadership and the wider research community.
Beyond helping institutions assess how they perform in relation to mandates or their institutional policy, the dashboard may inform interventions to increase the uptake of responsible research practices as well as evaluate the impact of these interventions.
Phase 2: The second part of TrackValue focuses on clinical research transparency. Transparent clinical research is crucial to the accessibility and usefulness of the underlying clinical work. Clinical trials should be transparent from prior to initiation (i.e., registration) to after study completion (i.e., reporting). We evaluated a sample of clinical trials led by German UMCs according to several practices for trial transparency based on regulations and ethical guidelines (e.g., prospective registration, reporting of summary results). Focusing on the Charité, we then generated individualized “report cards” with key information on the transparency of a given trial along with hands-on guidance on how to improve that trial’s transparency. We also created an infographic with an overview of guidelines, laws, and resources relating to clinical trial transparency. We are collaborating with the Charité Clinical Trial Office to disseminate these materials to trialists along with a survey to assess their usefulness. After a follow-up period of 6 months, we will evaluate improvement in trial transparency on 3 eligible transparency practices.
