CRDSA’s assets and resources can be found in this section of our site.

Resources designated “Member Access” are only available through CRDSA’s member portal and available to all employees of member organizations. If you are a non-member and would like to request a specific asset please send an email to info@crdsalliance.org.

Data Protection

Infographic: Navigating Data Protection and Privacy

Updated: January 31, 2024

Operationalizing privacy is challenging, but there are clear steps you can take to devise an operational policy that supports your business goals. This infographic lays out the important decision points in a logical, step-wise flow.

A Review of Biopharma Sponsor Data Sharing Policies and Protection Methodologies (updated September 2023): This whitepaper updates CRDSA’s 2022 systematic review of data contributor policies and data protection methodologies. This update includes information published by 35 biopharma sponsors. Highlights include:

  • The review now covers 35 biopharma sponsors, a 20% increase from 2022.
  • The consistency of dataset- and documentation-sharing policy commitments establish a reference benchmark for all data contributing organizations.
  • Challenges remain in the areas of data transformation transparency and data protection methodology.
Data Protection Decision Flow
Download the Data Protection & Privacy Decision Flow (PDF)

Technology and Innovation

Data Sharing Technology Assessment Framework

Updated: October 26, 2023
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. The Assessment Framework is now publicly available as an R Shiny application, with an accompanying introduction and guide.

Innovative Trial Design

FDA Draft External Controls Guidance

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.

Secondary Use Standards

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

Updated: 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.

General Resources

JAMA Oncology: Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages

Date: October 5, 2023
In this original investigation, Dr. Ashley Hopkins (Flinders University) and colleagues, including Frank Rockhold (Duke CRI and CRDSA Board Director) and Aaron Mann (CRDSA), address the utility and completeness of individual-participant data (IPD) and the supporting documents provided from industry-sponsored clinical trials. The study includes IPD packages received from 70 of 91 eligible clinical oncology trials. (77%) for a planned meta-analysis. The analysis indicated substantial variability within the provided IPD packages regarding the completeness of key data variables and supporting documents. To improve the data sharing ecosystem, key areas for enhancement include (1) ensuring that clinical trials are eligible for IPD sharing, (2) making eligible IPD transparently accessible, and (3) ensuring that IPD packages meet a standard of utility and completeness.

Article: Clinical data consortium seeks to establish best practices for supplemental controls

Date: February 15, 2023
Regulatory Focus, a publication of Regulatory Affairs Professional Society (RAPS), interviews CRDSA CEO Aaron Mann and COTA Healthcare’s Chief Medical Officer C.K. Wang, MD, on CRDSA’s demonstration project that seeks to establish best practices around the use of clinical trial and real-world data (RWD) in building supplemental control arms.

Podcast: Unlocking the True Potential of Clinical Research Data

Date: September 23, 2022

In Teckro’s podcast episode “Unlocking the True Potential of Clinical Research Data,” Aaron Mann discusses the importance of unleashing the power of clinical research data. Aaron explains why he’s optimistic about the potential of data sharing among sponsors to revolutionize trial design and improve patient recruitment – and why he believes patients really want their data to be shared.

Podcast: Mind Your Data: The First Rule of Predictive Analytics in Clinical Research

Date: June 17, 2022
In this episode of the IEEE Standard Association’s “Re-Think Health” Podcast Series, Aaron Mann and Maria Polombini discuss how open data sharing is paving the way to access more quality, real-world and inclusive data to enable predictivity analytics to be more accurate, resourceful, and utilitarian in the world of clinical research.

Article: Realizing the Promise of Data Sharing: A Multi-Stakeholder Collaboration

Date: January 3, 2022
This article in Clinical Leader discusses the challenges faced across the clinical data sharing ecosystem and how CRDSA’s Work Streams are addressing these challenges.