Resources

FDA Draft External Controls Guidance

Date: Updated August 22, 2023

Innovative trial designs that make use of the totality of available evidence can reduce the burden on patients and meaningfully improve the drug development process. In February 2023, the FDA released for public comment: “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products” (Docket FDA-2022-D-2983).

The draft guidance received over 200 responses from industry sponsors, patient advocacy organizations, academic research institutions, non-profit consortia, and patients. In July, CRDSA convened a roundtable panel of experts to discuss issues raised by commenting organizations and explore ways to ensure the expanded use of alternative control trial designs in regulatory submissions. The August 2023 FDA Draft External Controls Guidance: Situation Analysis and Recommendations report summarizes the roundtable discussion, key regulatory challenges, and recommendations.

“Establishing a Basis for Secondary Use Standards in Clinical Trials”

Date: March 8, 2023
This paper, published in Applied Clinical Trials, reports on CRDSA’s 2022 survey of biopharma and academic researchers. The paper discusses how common standards can accelerate the reuse of trial data, benefiting both data contributors and the research community. The results of the survey will inform the development of data contribution best practices.

Data Sharing Technology Assessment Framework

Date: November 14, 2022
CRDSA’s Technology and Innovation Work Group has developed a data-sharing technology assessment framework to support stakeholders in their evaluation of technologies and approaches that advance their data-sharing initiatives, whether they are interested in technologies for external data sharing or support an organization’s internal data reuse. The framework is designed to assist stakeholders in determining the requirements and use cases important to their organization. The resulting assessment scores can be used to compare how well different technology approaches or project scopes meet organizational objectives.

Whitepaper: A Review of BioPharma Sponsor Data Sharing Policies and Protection Methodologies

Date: September 12, 2022
This white paper examines clinical trial data contribution policies and the data protection methodologies applied to protect patient privacy. Information published by 29 biopharma sponsors was collected across three data-sharing platforms, collated by sponsor size. Results showed that large sponsor contribution policies can provide helpful benchmarks for medium and smaller sponsors. However, understanding the data protection methodologies applied by data contributors required the development of an interpretation rubric. This lack of clarity in the critical data transformation area can present a significant barrier for researchers and hinder their understanding of which studies will be useful in their research. Findings of the paper include highlighting an opportunity for sponsors to both aid researchers and reduce unnecessary data preparation work by sharing information with more consistency and clarity.