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?