The Ethical Case for Decentralized Clinical Trials
Kathryn Muyskens1, Centre For Biomedical Ethics, Nus 1Centre For Biomedical Ethics, Nus Singapore
Abstract
The Ethical Case for Decentralized Clinical Trials
Authors: Kathryn Muyskens, G. Owen Schaefer, Ivan Teo, Jerry Menikoff
Abstract:
The recent COVID-19 pandemic has spurred interest in innovative design for clinical trials. In particular, the constraints that the virus placed on the ability to gather people together led to an increase in decentralized or remote trials being conducted. Decentralized clinical trials (DCTs) have unique advantages significant enough to make them worthy of continued (or even increased) use. The current literature surrounding DCTs focusses on analyses of study effectiveness and the specific challenges of implementation, with limited attention to the normative implications of DCTs. In this paper, we set out to examine the normative implications of DCTs. We will argue that DCTs present an opportunity to extend the benefits of research to previously underserved populations, by decreasing participant burdens, increasing access to trials, and filling the knowledge gaps surrounding rare conditions (which are difficult to study when trials are bound to a specific location). Thus, there is both a scientific and moral case to extend and increase the use of DCTs beyond the context of public health emergencies. We acknowledge that DCTs are not without their own unique challenges and risks – especially regarding the quality of informed consent that can be attained remotely. Even so, these problems are far from insurmountable and the advantages are significant enough to merit increased attention and resources.
Biography
Dr Kathryn Muyskens is a Research Fellow with the SHAPES programme. She is a political philosopher and applied ethicist, and has research interests in human rights, international politics and health, with particular concerns around questions of trust, information, and inequality in access to healthcare.