EFFECTT

Empowering Funders For Enhanced Clinical Trial Transparency

Background and Rationale

For clinical trials to generate useful and generalizable medical knowledge gain, they should adhere to established guidelines for clinical trial transparency practices, such as prospective registration and timely results reporting. In previous work, we found some improvement in transparency over time, but still widespread non-compliance with these guidelines in the German science system, with many trials led by University Medical Centers failing to meet established registration and reporting standards. This lack of clinical research transparency threatens the validity of medical decision-making.

Funders are uniquely positioned to drive clinical trial transparency by setting policies, monitoring funded projects, and supporting compliance. German medical research funders have some recommendations or policies on trial transparency. However, it is unclear: a) how clinical trials they fund perform on established transparency practices, b) to what extent they monitor adherence to these practices, and c) whether they have existing programs to support compliance.

Aims

Building on our previous work and funders’ expert knowledge of their portfolios and needs, we aim to co-create and implement tools to increase clinical trial transparency in Germany and beyond. Overall, EFFECTT aims to empower funders to take sustainable steps towards improved transparency that align with their institutional aims and resources.

Methodology

The project combines quantitative and qualitative methods and consists of 4 Work Packages (WPs):

WP1 - Status quo analysis of clinical trials at the level of funders. We will combine data science methods and publicly available information to identify clinical trials funded by German medical research funders and associated results. We will assess this cohort for adherence to established guidelines on clinical trial transparency based on automated and manual approaches.

WP2 - Needs and opportunities to improve clinical trial transparency. This WP will consist of two phases.

•  Phase 1: Interviews to explore and understand funders’ existing policies, workflows, and needs for monitoring and supporting clinical trial transparency.
• Phase 2: Co-creation workshops with funders and other stakeholders with expertise in clinical trial transparency to adapt prototype tools (WP3) to identified needs. Workshops will also serve to explore areas for closer cooperation with funders and sharing of resources and expertise.

WP3 - Development of tools to improve clinical trial transparency. We will generate tools to monitor and increase clinical trial transparency (e.g., individualized feedback and guidance on trial transparency). This WP will be informed by other WPs at specific phases, reflecting a process of iterative feedback. 

WP4 - Implementation of tools for clinical research transparency. We aim to pilot the implementation of the finalized tools together with a funder to assess their impact and identify real-world obstacles to implementation.

Intended Outputs, Outcomes, and Impacts

The outputs developed in EFFECTT will include increased understanding of common challenges and needs of clinical trial funders, as well as scalable, co-created tools for monitoring and supporting transparency. A pilot implementation of these tools will serve to evaluate feasibility and usefulness and demonstrate their use to other funders. Intended outcomes include knowledge sharing among funders and other clinical trial stakeholders, and increased awareness and adoption of tools to drive clinical trial transparency. Together, these will spur long-term and wide-scale impacts: promote improvements to the scientific process, help curb research waste, and strengthen the validity of medical decision-making.

Related QUEST Projects

BRAVO: BRAVO examines the extent to which Germany's medical faculties consider and promote various aspects of quality of biomedical research.

TrackValue: TrackValue aims to improve biomedical research by developing relevant value indicators, assessing universities' performances on these indicators and giving feedback to individual researchers.

Funder transparency policies:This study assesses to what extent the policies and monitoring systems of the 21 largest public medical research funders in Europe meet best practice benchmarks as per the WHO Joint Statement.