Unlocking the vast potential that exists in combining and repurposing clinical trial data has advanced due to technological developments, but there is still hesitancy from many organizations as they weigh up the effort involved in harmonizing the datasets and concerns around protecting the privacy of participants. The growing influence of the GDPR in new legislation outside of the EEA and the associated fines and other sanctions that comes with it necessitate caution.

Various data protection methodologies (anonymization or strong pseudonymization) have been used by sponsors to safeguard privacy and comply with relevant laws and regulations. However, certain variations in approach can render the resulting data difficult and time-consuming to re-use and, in some cases, greatly reduce data utility, especially in the context of cross-study analysis. The issue can be further compounded by a lack of transparency in describing the specific privacy safeguards that have been applied, making it difficult to determine whether the data are fit for an intended secondary purpose.​

The vision for the Privacy Methodology for Data Sharing is to greatly improve transparency and reduce the variability in the methodology applied by companies to protect personal data in ways that facilitate secondary reuse of data. This proposed model approach would reduce the complexity associated with using the data within the DataCelerate modules and better facilitate cross-study analysis.

Additionally, the initiative aims to provide educational tools that study sponsors can use to help clinical trial participants better understand the levels of personal data protection measures that will be applied to their personal data, including an educational tool and a Frequently Asked Questions document.

Privacy Methodology for Public Review

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.

Why Public Review?

As we strive for greater transparency and reduced variability, TransCelerate would like to invite the public to provide their perspectives and input on the guidance and template within this methodology during a 3-month public review period. The goals of this review period is to:​

  • Solicit comments from potentially impacted stakeholders to strengthen the methodology in ways that preserve quality and participant privacy
  • Enhance the visibility of this new solution across the ecosystem to support global convergence in a highly varied and evolving space

We invite all interested commenters to participate by filling out the survey below.

For additional information, please see the Public Review: Informational Resource.


Adoption of the Privacy Methodology for Data Sharing deliverables will facilitate:​

  • Faster scientific insights and reduced participant burden through easier reuse of studies.
  • Greater transparency for clinical trial participants in the privacy safeguards applied to data resulting in increased data utility.
  • Better transparency for patients as to how their privacy is protected in clinical trials and subsequent reuse of data.

Similar Initiatives


What Is DataCelerate®? A global technology platform for clinical trials that allows for multiple de-identified research and development data types to be voluntarily submitted, uploaded, converted, harmonized, and downloaded through an access-controlled, secured environment. Serving as a data lake solution, the robust development and scalable design of DataCelerate features a flexible single sign-on platform with…

Historical Trial Data Sharing

The Historical Trial Data Sharing (Controls) Initiative was established to enable the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials.