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

See all articles by Ximena Benavides

Ximena Benavides

Yale University; Institution for Social and Policy Studies; Yale University - Yale Information Society Project

Date Written: August 31, 2023

Abstract

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.

Note:

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

Benavides, Ximena, Digital Clinical Trials and Private Equity Firms (August 31, 2023). HEALTH LAW AS PRIVATE LAW: PATHOLOGY OR PATHWAY? (Cambridge University Press, I. Glenn Cohen, Wendy Netter Epstein, Christopher Robertson & Carmel Shachar, eds., 2024), Forthcoming, Available at SSRN: https://ssrn.com/abstract=4565316

Ximena Benavides (Contact Author)

Yale University ( email )

31 Hillhouse Ave.
New Haven, CT 06511
United States

Institution for Social and Policy Studies ( email )

New Haven, CT 06520
United States

Yale University - Yale Information Society Project ( email )

127 Wall Street
New Haven, CT 06511
United States

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