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Privacy Methodology for Data Sharing Solutions

The resource below was developed by the Privacy Methodology for Data Sharing Initiative in an effort to promote greater transparency for clinical trial participants about the privacy safeguards applied to data provided for reuse, to ensure improved data utility while safeguarding data privacy of trial participants.

Privacy Methodology for Public Review (Closed)

Review Period: Nov 30, 2022 to March 17, 2023

TransCelerate Member Companies currently share clinical trial data through the Historical Trial Data initiative. To improve the quality of the data while protecting patient privacy, TransCelerate has developed a proposed privacy methodology. The methodology aims to greatly improve transparency and reduce the variability in the data protection methods applied by companies to safeguard personal data in ways that better enable the secondary reuse of structured patient-level clinical trial data shared in a controlled environment. This methodology reflects emergent thinking from the TransCelerate Member Companies into recommendations and considerations for 14 key variable types with examples and logic for how a transformation could appear before and after.

This solution may provide greater consistency and valuable guidance for Data Providers (those responsible for preparing and/or sharing clinical data for reuse) in their approach to anonymize/de-identify data for reuse, which in turn may increase usability. It also provides a template to capture relevant information about the data protection methods that better inform downstream data users (those responsible for using the shared data for scientific research). TransCelerate is interested in comments on the methodology and whether it might be useful to other organizations or groups facing challenges related to the reuse of clinical trial data.

Please note that each company remains responsible for ensuring the privacy and security of the contributed datasets in accordance with their internal procedures and defined risk thresholds, as well as compliance with applicable laws and regulations.

What’s Next?

The public review period is officially closed. TransCelerate’s Privacy Methodology for Data Sharing initiative team will be addressing all comments and feedback as we refine the solution toolkit for final release anticipated at the end of 2Q 2023.

For additional information, the following resources are available for your viewing:

A Privacy Framework for Clinical Data Reuse

In 2020, TransCelerate published a framework to help companies address privacy questions related to clinical trial participant data and increase the potential reuse of clinical data. An increase in data reuse reduces the burden on patients, with less data needing to be collected as the use of existing data is maximized. In addition to the framework paper, entitled, “A Privacy Framework for Clinical Data Reuse: Secondary Data Use in the Pharmaceutical Industry” you can also view tools and an overview video on the TransCelerate website here. The TransCelerate Privacy team is currently building upon this framework through the development of a Privacy Methodology Toolkit for Clinical Data Reuse that identifies approaches to implement privacy safeguards for relevant variable types, along with logic and transparency mechanisms, to ensure data protection as well as maximized data utility.

Educational Tookit for Clinical Data Reuse

This educational toolkit can be used by study sponsors to help clinical trial participants better understand the data protection measures that will be applied to their personal data. To increase user friendliness, technical terminology, such as ‘anonymization’ or ‘pseudonymization’, and how this relates to the protection of personal data, is avoided. The toolkit includes two key elements:

  1. Educational Tool: Download PDF and PowerPoint. The editable educational tool will provide a visual, consistent, succinct, easy-to-understand breakdown for the clinical trial participant outlining how patient privacy is protected by study sponsors. The tool can be edited by a sponsor as necessary to reflect the process it uses.
  2. Supporting Document & FAQ: Download Word Doc. The supporting document provides important context about the educational tool and can aid study sponsors in answering common questions asked by IRBs and Ethics Committees.

This educational toolkit may be useful to several study sponsors roles including Trial Managers (who prepare the Informed Consent Form being provided to trial participants) as well as legal or data protection roles (that review Informed Consent language).