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Project

Do the EU and relevant national legal frameworks provide for a fair allocation of data control and responsibility in the context of precision medicine? A case study of clinical trials

Clinical research relies on patient participation and the use and (re-)use of sensitive personal data. Moreover, several types of research are heavily dependent on exchange of data between countries (e.g., precision medicine trials), and all health research would benefit from greater, meaningful cross-border collaborations, as shown during the COVID-19 crisis. However, the current legal system for the conduct of cross-border research in the EU is complex. Questions have arisen on how to navigate the system optimally to avoid compromising research while sufficiently protecting the fundamental rights and interests of the patients, and particularly their right to data protection.

The overall aim of this PhD project is to systematize and evaluate the existing challenges, elucidate stakeholders’ perceptions, and to propose a way forward for cross-border clinical trials. The project is guided by the following main research question: “Does the EU legal framework provide for a fair allocation of data control and responsibility in clinical research?” and employs an interdisciplinary approach. Legal investigation into the interplay of selected key legislative acts is coupled with empirical evidence (obtained through qualitative and quantitative research) about the real-life experience of actors in the field, such as sponsors, investigators, ethics committee members, patients and patient representatives.

Following the General introduction (Chapter 1), which outlines the background, objectives and methods of the dissertation, Part 1 comprises Chapter 2 and maps the ethical and legal rules relevant for clinical trials in the European Union, as well as the main actors who have a role in clinical research. This chapter also identifies the criteria employed for evaluating the legal framework in the concluding discussion. Finally, the concepts of fairness, control and responsibility are described.

Part 2 consists of six chapters (Chapters 3 to 8) and focuses on identifying the challenges and systematizing solutions with respect to cross-border clinical trials.

Chapter 3 provides analysis of the current situation in cross-border access to clinical trials in the EU, with an empirical overview of stakeholders’ experiences (sponsors, investigators, ethics committees, patients, regulators). The majority of study participants agreed that cross-border access to clinical trials in the EU is needed but is rarely occurring at the moment. However, most interviewees were of the opinion that patients ideally should not have to travel in order to access experimental treatment. There was a consensus on the need for reliable and accessible information and recommendations regarding practical aspects of cross-border access.

Chapters 4 to 8 focus on clinical trials conducted in multiple countries, and use as a focal point for investigation the interplay of the data protection rules and the clinical research legal and ethical frameworks. In particular, Chapter 4 critically discusses the allocation of responsibility in clinical research. It outlines the concepts of controller and processor as actors responsible for ensuring compliance under the EU General Data Protection Regulation (GDPR), applies these concepts in the context of clinical trials, and identifies current gaps and uncertainties that may hamper the effective and complete protection of study participants. Chapter 5 provides empirical evidence about the experience of clinical research stakeholders (sponsors, investigators, ethics committees) in complying with the data protection rules before and during the COVID-19 pandemic, in the context of both primary and secondary use of personal data. Survey and interview data showed that the lack of legal harmonization remains the biggest challenge in the field. The insufficient harmonization is evident not only at the level of the interplay of key EU legislative acts and as regards the national implementation of the GDPR, but also when it comes to interpretation at local, regional and company level. A key finding was related to the role of ethics committees in data protection. Namely, the study suggested that ethics committees tend to advise sponsors and investigators on various GDPR-related matters that are the responsibility of the data controller (such as the choice of an appropriate legal basis), both for primary and secondary use of personal data.

Chapter 6 further elucidates, from a legal point of view, specific issues related to the topic of secondary use of personal data and incorporates discussion about the novel legislative initiatives proposed with the European Strategy for Data, such as the Data Governance Act (DGA) and the European Health Data Space (EHDS) proposal. Building further, Chapter 7 delves into the novel data altruism mechanism introduced in the DGA and the challenges and opportunities it poses both for clinical trials and for patients’ fundamental rights. Empirical research serves as a starting point for in-depth legal reflection. Although interviewed stakeholders (sponsors, investigators, ethics committees) opined that data altruism holds the potential to facilitate data sharing, and to further foster and harmonize data altruism practices across the EU, at the moment, the application of the concept in practice is still riddled with uncertainties and challenges, particularly in the field of clinical research, and further efforts from the legislator are required to build a working, patient-centered, and research-fostering data altruism system.

Finally, Chapter 8 investigates the European patients’ awareness about and perspectives on data protection and data control in research via an online survey. Although survey participants had high awareness about the GDPR, they rarely exercised their data subject rights. The results highlighted the importance of providing more in-depth education about data protection and privacy. Participants valued data control and identified positive and negative outcomes to its use that were aligned with the ongoing thought debates in literature. Although respondents showed a slight preference towards individual data control tools, the reflection based on previous academic research identified that individual control holds risks that could be mitigated through carefully operationalized collective tools.

Part 3 is composed of the Concluding discussion (Chapter 9). In it, the research objectives are revisited and a critical reflection on the main findings is provided, along with recommendations for addressing the main challenges identified in this PhD project. The recommendations are based on the combined knowledge of the individual chapters and are organized in three groups related to 1) change in practice, 2) the provision of authoritative guidance, and 3) legal and regulatory matters. Finally, avenues for future research are identified. 

Date:5 Oct 2018 →  31 Oct 2023
Keywords:precision medicine, clinical trials, data protection, clinical research, patients' rights
Disciplines:Biomarker discovery and evaluation, Drug discovery and development, Medicinal products, Pharmaceutics, Pharmacognosy and phytochemistry, Pharmacology, Pharmacotherapy, Toxicology and toxinology, Other pharmaceutical sciences
Project type:PhD project