The TransCelerate Privacy Methodology for Data Sharing solutions below were developed to promote reuse of clinical trial data while protecting patient privacy.
The Solutions comprise two distinct sets of tools:
Privacy Methodology for Clinical Data Sharing
Building upon existing solutions in the industry, the Privacy Methodology for Clinical Data Sharing solutions identifies privacy safeguard approaches for relevant variable types and provides logic, allowing sponsors to define approaches at the actual variable level within each SDTM (Study Data Tabulation Model).
It includes the final Clinical Data Sharing: A Proposed Methodology to Enable Data Privacy While Improving Secondary Use and a Transparency Checklist that can be used independently of the methodology.
Educational Toolkit for Consent Specific to Data Reuse
This customizable educational tool, published in February 2022, explains methods of protecting patient privacy. It also includes an Educational Poster about privacy safeguards applied to patient data provided and an FAQ to assist sponsors in answering questions from IRBs (International Review Boards) and Ethics Committees on privacy terminology and data sharing.
Some of the earlier solutions are listed below:
- “De-Identifying and Anonymization of Individual Patient Data in Clinical Studies – A Model Approach” (2015)
- “A Privacy Framework for Clinical Data Reuse: Secondary Use in the Pharmaceutical Industry“ (2020)
Key Considerations for Readers and/or Users of the Privacy Methodology
- TransCelerate did not develop this methodology as a replacement for current pseudonymization/anonymization approaches used by sponsors, vendors, and other relevant stakeholders.
- The methodology is not sufficient, without more, to anonymize clinical trial data. Users of the Privacy Methodology remain responsible for their own compliance with all applicable laws and regulations.
- Users should consider how the Privacy Methodology works in connection with their current approaches to increase data utility.
Public Review: November 20, 2002 to March 17, 2023
TransCelerate submitted to public review the draft Privacy Methodology for Clinical Data Sharing. During a 4-month period ending in March 2023, comments on the draft Privacy Methodology were received from various stakeholders.
The team incorporated these comments to improve the robustness and clarity of the privacy methodology and the revised version is now publicly available.
The process: why a public review?
The Proposed Privacy Methodology was submitted to public review from November 30, 2022 to March 17, 2023 as an effort to:
- Solicit Input from the broader R&D ecosystem to improve the draft methodology and better ensure the feasibility of the deliverable.
- Enhance Visibility of this new TransCelerate solution to avoid duplication, identify gaps in solution development, and enhance potential adoption of this solution beyond the Member Companies (MCs).
The public review period was a success!
- More than forty comments were received from six different stakeholder groups across the clinical research ecosystem (Academia, Vendors, BioPharma/Pharmaceutical Companies, Data Sharing Platforms, Trade Associations/Industry Consortia, Regulators).
- The feedback received was positive and pointed to:
- Value/Usefulness of having a solution like this in the industry
- Readability and comprehensibility of the variables
- Usefulness of the Data Transparency Checklist
Public review comment received from one Data Sharing Platform:
“Overall, this is a very well written and readable document. Look forward to being able to disseminate this when finalized.
I believe this will be very useful to the community. Nice work!”
Comments Review and Outcome
- No major conflicting conceptual or structural feedback was part of the comments received.
- Most edits contributed to enhancing the robustness and the clarity of the draft Privacy Methodology document.
- The full responses to the comments and the revised Privacy Methodology are available in the next section.
- The responses to the comments received may not represent the individual views of all participating Member Companies.
- We sought permission to publish all the comments we received. The response document does not include the comments that the Privacy Methodology initiative does not have permission to share.
- In addition, comments have been edited to remove identifying information and any marketing content.
To read the responses to the comments received during the public review period, click here.
The supportive information provides additional information on the Privacy Methodology, the various approaches described in the document and some examples. For an overview of the Privacy Methodology and Transparency Checklist, the supportive information and video link is available for your viewing.
The Transparency Checklist is a template that seeks key information, from a data user’s perspective, describing the data modifications/derivations performed to enable the data user to assess the usability of the data.
This template or a similar document aids greater transparency for researchers to understand the data they are using and can be used independently of the methodology.
For more information on the variables listed in the Transparency Checklist, please refer to the Privacy Methodology.
Privacy terms can be confusing, especially to patients. To address this need, in 2022, the “Educational Toolkit for Consent Specific to Data Reuse” was released.
The toolkit provides Institutional Review Boards/International Ethics Committees, Health Authorities, and clinical trial participants with an explanation of how patient privacy protection works at a participant-friendly level.
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.
The toolkit includes two key elements:
1. Educational Poster: 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 editable 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).