A risky business: hydroxychloroquine, global health politics, and the bureaucratization of clinical trials

The clinical trials governance landscape has evolved dramatically since the 1980s. With the wide adoption of the International Conference on Harmonization’s Good Clinical Practices (ICH-GCP) internationally, private actors have arisen to help researchers meet the demands of such “document-based accountability” mechanisms. Contract research organizations, clinical trial database and validation companies, insurance brokers, and methodology consultants have proliferated in a growing global clinical trial marketplace, as they offer the promise of global recruitment and risk mitigation.

In February 2020, just weeks after the first publications on the COVID-19 virus, the Mahidol-Oxford’s Tropical Medicine Research Unit (MORU)’s team discussed re-purposing the widely used anti-malarial chloroquine/hydroxychloroquine for COVID-19. MORU researchers quickly received funding for a large, multi-country randomized controlled trial of chloroquine/hydroxychloroquine as a prophylaxis for COVID-19, the “COPCOV trial”, with results expected by the end of 2020. Yet, the trial quickly faced political fallout from “hydroxy hysteria” in the media and a fraudulent paper published in The Lancet; authorization hurdles related to ICH-GCP and other bureaucratic entanglements; and delays due to various actors’ risk aversion.

This talk draws on my ongoing postdoctoral research as the “COPCOV trial historian”. I focus on a broad research question: What does the COPCOV experience illuminate about clinical trial political influence, “epistemic monopolies”, marketplaces, and global governance in the modern era?