Digital Clinical Trials and Private Equity Firms
HEALTH LAW AS PRIVATE LAW: PATHOLOGY OR PATHWAY? (Cambridge University Press, I. Glenn Cohen, Wendy Netter Epstein, Christopher Robertson & Carmel Shachar, eds., 2024), Forthcoming
10 Pages Posted: 26 Sep 2023 Last revised: 19 Dec 2023
Date Written: August 31, 2023
Over the last two decades, the use of digital technology in clinical trials has proliferated, a shift which has been argued to reach a more diverse and representative trial population more efficiently. Also known as decentralized clinical trials or DCTs, digital clinical trials saw a vastly increased use amidst the COVID-19 pandemic, when remote methods were employed to reach trial participants who could not reach trial sites in person. While improving clinical trial accessibility through decentralized approaches is important, it is also crucial to understand who is leading these efforts in the generation of scientific evidence. , This essay re-centers the relationship between private equity and clinical trials in the analysis of DCTs and the public value of access in the for-profit, private production of scientific evidence. In a highly fragmented biotechnology industry, where private equity (PE) firms are increasingly acquiring small firms that provide outsourced clinical research services, DCTs and PE firm unions might bring about additional opportunities to increase drug data opacity, compromising the access to the greater production of scientific evidence driving digital technology.
Structured in three parts, the essay examines the current state of DCTs and questions whether trials remaining in the hands of PE firms is convenient for data generation and securing open science and access to quality medicine. The first part discusses the exponential growth of DCTs, particularly in the years following the pandemic, and their potential to address challenges of the traditional on-site clinical trial model. The second part examines private equity firms’ increasing interest in DCTs from a business, law, and policy perspective. The final part discusses the risks of generating scientific evidence through profit-driven models with a special focus on the issues of publicity in the wider political economy of PE-funded medical research.
Funding Information: None.
Conflict of Interests: None.
Keywords: Clinical trials, digital clinical trials, decentralized, private equity, health equity, access, medicine
JEL Classification: I11, I14, I18,
Suggested Citation: Suggested Citation