Enhancing access to clinical trial data for secondary use

Contact

@John Wise (Unlicensed) @Becky Upton

 Email us at 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 up on 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 will have a view on the eligibility of the secondary use of the data in 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 to 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.