Bringing clinical research to patients: Ethical aspects of decentralized clinical trials

Abstract

Clinical trials with human participants are essential for determining the efficacy and safety of novel drugs and medical treatments. The development of novel drugs and treatments through various phases of clinical trials is a lengthy and complex process. Several aspects of current clinical trial practices are hindered by scientific and operational obstacles, such as issues with recruitment and retention and the limited generalizability of results. Decentralized clinical trials (DCTs) have been introduced as a potential solution to these obstacles. DCTs are an operational approach that employ technologies and other innovative approaches to conduct trial activities in participants' usual surroundings, rather than at traditional research sites. The use of decentralized approaches potentially lowers the burden of clinical trial participation, as participants do not have to travel to a research site. DCTs also contribute to more generalizable data by collecting information in participants' usual circumstances. However, the adoption of fully decentralized trials faces regulatory and ethical challenges, as these trial approaches are new to the system of ethical and regulatory oversight. This dissertation first examines the perspectives of members of regulatory bodies, such as research ethics committees and national competent authorities, on DCTs. These regulators foresee several advantages of DCTs, but also additional risks and challenges, including maintaining safety and potential impacts on the researcher-participant relationship. The second part of the dissertation analyzes the impact of DCTs on various research ethics aspects. Several ethical issues are explored in detail, such as the impact of decentralized approaches on informed consent processes. Moreover, the role of DCTs' benefits in risk-benefit assessments is examined. Finally, diversity and fair participant selection are analyzed in the context of decentralized trials. To conclude, DCTs hold important promises to improve the conduct of clinical research, in both scientific and operational regard, and in particular also for trial participants. At the same time, the findings in this dissertation suggest that realizing these promises in practice is not self-evident and requires concerted effort from multiple stakeholders to steer these novel practices in a desirable direction, ultimately advancing and optimizing drug development.