Returning Clinical Trial Data to Study Participants within a GDPR compliant and approved framework

A large amount of high-quality health data is collected during clinical studies (interventional and non-interventional), but, beyond the immediate objectives of the study, these valuable data are not used to the extent they merit. For example, these data could be used to enrich patients’ health care records to improve clinical decision-making and reduce duplication in procedures/ investigations. In addition, returning clinical trial data to patients could allow them to contribute their data for additional scientific research (e.g. patient-powered research), in particular for rare diseases where treatments and data are scarce or unavailable. Finally, the lack of transparency and sharing of

clinical trial data could contribute to the lack of patient willingness to be involved in studies, delays in clinical study set up and conduct, and delays in conducting health research in Europe to the detriment of vulnerable patients and public interest in general.

Some of the main barriers to returning clinical trial data to study participants include:

  • Complexities of determining acceptable common data format, processes or infrastructure;
  • Concerns of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) and EU Clinical Trial Regulation (CTR) (e.g. including study integrity, privacy and confidentiality); and
  • Lack of clarity and harmonisation of the General Data Protection Regulation (GDPR) across EU Member States, whether for primary and/or secondary use of individual clinical trial data (personal data).

This project has two main objectives, which are equally important:

  • The first one is to align local and pan-European implementations and best practice for handling personal data protection regulations in order to harmonise the legal framework applicable to medical research;
  • The second one is to deliver a pan-European prototype process to return clinical trial data to study participants. This prototype process will be delivered as part of the project alongside a robust business plan to ensure its sustainability.

To support these objectives, the project will:

  • Define harmonised rules for complying simultaneously with data protection regulations and regulatory requirements in Europe. These rules are to be endorsed by appropriate regulatory bodies and patients;
  • Define which, when and how clinical trial data should be returned to study participants, including for integration in, or interconnection with, patients’ individual health records management files or applications
    and, where they exist, national and/ or hospital EHR systems (for clarity, no ‘lay summaries’ or other expert analyses are within the scope of this project);
  • Define how individual clinical trial data is (or can be) utilised for both health care decision making and future research; and
  • Ensure that the whole process, from collection of data to its destruction or anonymisation, including sharing of individual personal data, is aligned with the study participants’ expectations and the authorities and ethics committees’ expectations and documented in binding and/ or approved standards or guidance document

Read more here.