Archives
Date: September 25, 2024
Type: Standards
Work Group: Secondary Use Standards
The CRDSA Std 2001: Standard for Secondary Analysis of Clinical Study Data (v1.0) aims to help researchers conduct robust analyses and objectively interpret the findings generated from the use of shared patient data. The standard encompasses the end-to-end research process, and its application will reduce the risk of inadvertent errors or bias that may lead to conclusions potentially detrimental to scientific understanding and patient care.
CRDSA’s process for standards development can be found here.
Date: September 25, 2024
Type: Standards
Work Group: Secondary Use Standards
The CRDSA Std 1001: Standard for Sharing Clinical Study Data (v1.0) promotes data completeness, consistency, interoperability, and information transparency. These qualities are essential for the research community and, equally important, benefit data contributors by ensuring that their investment in data preparation time and resources will maximize research outcomes.
CRDSA’s process for standards development can be found here.
Date: February 29, 2024
Type: Webinars & Videos
Work Group: General Resources
Drawing from their unique perspectives, CRDSA’s board members discuss the foundational elements needed to support a data reuse ecosystem that best serves patients, accelerates drug discovery, and advances human health.
Date: February 29, 2024
Type: Webinars & Videos
Work Group: Innovative Trial Design
This keynote presentation by Mark McClellan, Director of the Duke-Margolis Institute for Health Policy and former commissioner of the U.S. Food and Drug Administration, provides a thought-provoking analysis of the current state of Real-World Data and Evidence in regulatory use. Major themes include “regulatory grade” RWD/E, audit readiness and data fitness, learning health systems, and fit-for-purpose clinical trial design.
Following the keynote, a panel of experts discussed what’s on the regulatory horizon, from the use of alternative data sources to novel trial designs to AI-generated evidence.
Date: February 29, 2024
Type: Webinars & Videos
Work Group: Data Protection
In this session from our February 2024 Summit, experts from CRDSA and TransCelerate Biopharma discussed how to navigate the complex data protection governance process, and how existing resources like TransCelerate’s methodology can help companies efficiently enable data privacy while improving secondary use.
Date: January 31, 2024
Type: Articles
Work Group: Data Protection
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.Date: October 26, 2023
Type: Framework & Tools
Work Group: Technology & Innovation
In 2022, CRDSA released the Data Sharing Technology Assessment Framework to help data contributors, platform owners, and researchers determine the requirements and use cases important to their organization. The Assessment Framework is now publicly available as an R Shiny app for easier use, along with an accompanying introduction and guide.
Date: October 5, 2023
Type: Articles
Work Group: General Resources
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.
Date: September 28, 2023
Type: Webinars & Videos
Work Group: Data Protection
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.
Date: August 22, 2023
Type: Framework & Tools
Work Group: Innovative Trial Design
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, nonprofit consortia, and patients. In July 2023, 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 report, “FDA Draft External Controls Guidance: Situation Analysis and Recommendations,” summarizes the roundtable discussion, key regulatory challenges, and recommended actions.
Date: March 8, 2023
Type: Standards
Work Group: Secondary Use Standards
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.
Date: February 15, 2023
Type: Articles
Work Group: General Resources
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.
Date: November 14, 2022
Type: Framework & Tools
Work Group: Technology & Innovation
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.
Date: September 23, 2022
Type: Podcasts
Work Group: General Resources
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.
Date: June 17, 2022
Type: Podcasts
Work Group: General Resources
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.
Date: January 3, 2022
Type: Articles
Work Group: General Resources
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.