Secondary use of Clinical Data

Date: June 2021

Who to Contact: projectenquiries@pistoiaalliance.org

Problem Statement

Today, in many Pharma companies it takes considerable time (months?) for an internal business function, such as research, to gain access to the company’s clinical data assets.

Specifically, secondary use of clinical trial data needs approval by the appropriate function in the company (legal/compliance). This approval is dependent upon that legal compliance function being able to understand if the informed consent form (signed by the patient involved in the clinical trial) provides permission for the company to access the data for secondary use. 

Furthermore, in a global clinical trial, patients will be recruited from many different nation states, each of which will have a national competent agency (regulatory agency) which may have a view on the eligibility of the secondary use of the data from that clinical trial. 

Value Proposition 

Establish a Pistoia Alliance cross-company project team to specify an (AI/ML/NLP-powered?) system that will analyse the informed consent forms in all their relevant languages and analyse the requirements of all the relevant national competent agencies. This system can then provide advice to the company’s legal/compliance function such that it can make its decision in a timely manner.

Furthermore, such analysis would provide valuable insights to improve the utility of the company’s informed consent forms in the future.