Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All of this "big data" also have high value, not only for clinical trials, but also for further analysis and R&D to improve products.
But the process, regulation, and sensitivity of health care data itself is a serious concern, says Patrice Navarro, counsel in the Hogan Lovells Paris office. And that's where the General Data Protection Regulation (GDPR) comes into play. Collection and processing of data is regulated by both the GDPR and, indirectly, by local public health regulations. To use the data and fully extract its potential value, it's critically important to ensure that data collection, processing, and security is in compliance with the GDPR and local regulations.
In this hoganlovells.com interview, Patrice Navarro explores the highly regulated realm of health data and clinical trials in Europe, and the numerous actors and stakeholders involved in personal data use and protection.
Why are clinical trials increasing in both importance and number?
Patrice Navarro: Until recently, clinical trials were mainly sponsored by pharmaceutical companies to support their marketing authorization request for a drug. Now, they are also needed post-market to show the benefit of their products. In addition, medical devices have increased in use and importance and medical device manufacturers are obligated to perform clinical trials to prove their devices have the right effect.
In order to do that, you need more post-marketing trials and more papers published in peer-reviewed journals to convince HCPs healthcare professionals that your product or device is very useful for patients. So pharma companies and medical device manufacturers need more and more data, including for secondary usage, to analyze for R&D and improve their products and devices.
Why is health care data collection in European clinical trials so complex?
Navarro: Because it involves a lot of different actors and stakeholders with different interests: sponsors, contract research organizations, patients, investigators, sites, ethics committees, and national health care authorities.
The sponsor is the entity benefitting from and paying for the trial, and that would be the pharma company or medical device manufacturer. You also have contracts with service providers...