Reuse of clinical trial data honors a patient’s contribution by using data to the fullest extent possible, while advancing the speed and quality of drug development. 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 consider the requirements around protecting the privacy of participants. The growing influence of the GDPR (General Data Protection Regulation) in legislation outside of the EEA puts privacy at the forefront of the agenda when it comes to Clinical Data Sharing and Reuse.

Sponsors use varying data privacy measures (anonymization and/or pseudonymization) to safeguard patient privacy and comply with relevant laws and regulations. Those variations in approaches may result in making data difficult and time-consuming to reuse and, in some cases, may 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, thereby 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 improve transparency and reduce variability in the methodology applied by companies to protect personal data in ways that facilitate the reuse of data. The proposed approach could reduce the complexity associated with data sharing and better facilitate cross-study analysis.


Using the Privacy Methodology for Data Sharing tools can enable:

  • Improved data utilityfor secondary reuse, resulting in faster scientific insightsand increased patient benefit.
  • Greater consistency in the data protection approaches for structured patient-level clinical datain ways that facilitate data reuse.
  • Increased transparencyto privacy safeguards of the data sharedto facilitate reuse.

Related 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.