Returning Clinical Trial Data to study participants within a GDPR compliant and approved ethical framework

Topic description

Specific Challenge:

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. Subject to appropriate legal grounds, these data could be used to enrich patients’ healthcare 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.

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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 foster the harmonisation of the legal framework applicable to medical research in the Member States;
• The second one is to deliver a pan-European prototype process to return clinical trial data to study participants, building on previous and ongoing EU-level activities on citizen-centric access to health records. 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, regulatory requirements and ethical standards 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) and EHR standards such as EEHRxF;
• Define data governance models for cases where individual clinical trial data is (or can be) utilised for both healthcare decision making and future research, taking into account previous and ongoing EU-level activities on data governance in these fields;
• 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’ standards and procedures, and documented in binding and/or approved standards or guidance documents.
  
  Please refer to Call topic text.

In their proposals, applicants should describe how the outputs of the project will contribute to the following impacts and include, wherever possible baseline, targets and metrics to measure impact:

• For patients: the project results should empower patients by returning their clinical trial data to them and to their medical records. Data acquired during clinical trials will aid better shared medical decision-making and reduce duplication in procedures/investigations;
• For healthcare professionals: enriched healthcare data obtained during clinical care should aid better clinical decision making and reduce duplication in patient procedures/investigations;
• For EU research: giving patients control of their clinical trial data will open possibilities for ethical data re-use e.g. if the patients opt in to donate their data to a common data sharing platform;
• For pharma: returning clinical trial data to study participants during study conduct has the potential to improve adherence to study procedures and improve overall patient retention. Facilitate conduct and setup of clinical studies as well as access to health data for research. Doing this in a meaningful way will further help to educate patients and in doing so empower them to be equal partners in the management of their disease;
• For regulators: it is an opportunity to exchange opinions with counterparts from other countries and researchers to propose informed workable aligned positions;
• From a societal perspective: the project will increase the transparency of clinical study and therefore increase the trust of patients in clinical research. At a time where clinical trials are increasingly complex, this may help with recruitment for studies and improve oversight by patients and regulators on clinical data re-use.
  
  In their proposals, applicants should outline how the project plans to leverage the public-private partnership model to maximise impact on innovation, research & development; regulatory, clinical and healthcare practices, where relevant. This could include a strategy for engagement with patients, healthcare professional associations, healthcare professionals, regulators, ethics committees, HTA agencies, payers etc., where relevant.
  
  In addition, applicants should describe how the project will impact the competitiveness and growth of companies, including SMEs.
  
  Moreover, in their proposals, applicants should outline how the project will:
  
• Manage research data and adhere to ethics requirements ;
• Disseminate, exploit, and sustain the project results. This may involve engaging with suitable biological and medical sciences research infrastructures .
• Support the improvement of the interoperability of EHRs by aligning with the EEHRxF.
• Communicate the project activities to relevant target audiences
  
  Please refer to Call topic text.