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A python's embrace? Insurance and the global clinical trial.

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Titel: A python's embrace? Insurance and the global clinical trial.
Autoren: Winters J; Humanitarian and Conflict Response Institute, Ellen Wilkinson Building, School of Arts, Languages and Cultures, University of Manchester, Manchester, M15 6JA, UK. janelle.winters@history.ox.ac.uk.; Centre for the History of Science, Technology and Medicine, Faculty of History, University of Oxford, Oxford, England. janelle.winters@history.ox.ac.uk.; Pandemic Sciences Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. janelle.winters@history.ox.ac.uk.
Quelle: Health research policy and systems [Health Res Policy Syst] 2026 Feb 09. Date of Electronic Publication: 2026 Feb 09.
Publication Model: Ahead of Print
Publikationsart: Journal Article
Sprache: English
Info zur Zeitschrift: Publisher: BioMed Central Country of Publication: England NLM ID: 101170481 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1478-4505 (Electronic) Linking ISSN: 14784505 NLM ISO Abbreviation: Health Res Policy Syst Subsets: MEDLINE
Imprint Name(s): Original Publication: [London] : BioMed Central, 2003-
Abstract: Background: Regulatory barriers present significant challenges to clinical trial approval during both "peacetime" and pandemics, particularly for multi-country clinical trials sponsored by academic institutions and low- and middle-income countries (LMICs). While such barriers have been depicted as a "python's embrace", analyses of trial approval efficiency and ethical frameworks have largely overlooked clinical trial insurance.
Methods: I interrogate the evolution of clinical trial indemnification mechanisms, rationales, and operationalisation over the past fifty years through a structured literature review. I then consider the procedural barriers faced by academic institutions conducting multi-country clinical research during the COVID-19 pandemic using a case study of the University of Oxford's "COPCOV" trial, which was led by the Mahidol Oxford Tropical Medicine Research Unit in Bangkok, Thailand. This includes thematic analysis of more than 65 semi-structured interviews with trial stakeholders and analysis of insurance documents from the Trial Master File and hundreds of stakeholder emails.
Results: Supplementary reinsurance policies cost over £110,000 during the COPCOV trial, delayed trial approvals by up to nine months in some countries, and were largely justified by sponsors based on concerns about reputational damage. I argue that risk frameworks grounded in financial risk management and the commercial sector have expanded within academic institutions and, when coupled with an expansion of national requirements for "local paper" insurance policies, create serious barriers to initiating trial sites in many LMICs.
Conclusions: Two potential reform pathways, which are grounded in procedural or systemic reforms and should be led by LMIC-based policymakers, could help to de-barrier clinical trial insurance procedures and ensure that evidence of efficacious (and affordable) countermeasures are available during future global health emergencies.
(© 2026. The Author(s).)
Competing Interests: Declarations. Ethics approval and consent to participate: The research was conducted with ethical approval from the University of Oxford (CUREC R81146/RE001) and the University of Manchester (UREC 2023–18356-32399). Consent for publication: The informed consent process covered consent for publication, and stakeholders interviewed have been anonymised according to their preferences. Participants will be provided with a copy of the draft manuscript prior to publication in the case that they requested this during the consenting process. Competing interests: The authors declare no competing interests.
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Grant Information: 221307/Z/20/Z United Kingdom WT_ Wellcome Trust
Contributed Indexing: Keywords: Clinical trial governance; History of norms/standards; Multi-country clinical trial barriers; Randomised controlled trial globalisation; Research policy; Trial insurance policy
Entry Date(s): Date Created: 20260210 Latest Revision: 20260210
Update Code: 20260210
DOI: 10.1186/s12961-026-01449-6
PMID: 41664063
Datenbank: MEDLINE
Beschreibung
Abstract:Background: Regulatory barriers present significant challenges to clinical trial approval during both "peacetime" and pandemics, particularly for multi-country clinical trials sponsored by academic institutions and low- and middle-income countries (LMICs). While such barriers have been depicted as a "python's embrace", analyses of trial approval efficiency and ethical frameworks have largely overlooked clinical trial insurance.<br />Methods: I interrogate the evolution of clinical trial indemnification mechanisms, rationales, and operationalisation over the past fifty years through a structured literature review. I then consider the procedural barriers faced by academic institutions conducting multi-country clinical research during the COVID-19 pandemic using a case study of the University of Oxford's "COPCOV" trial, which was led by the Mahidol Oxford Tropical Medicine Research Unit in Bangkok, Thailand. This includes thematic analysis of more than 65 semi-structured interviews with trial stakeholders and analysis of insurance documents from the Trial Master File and hundreds of stakeholder emails.<br />Results: Supplementary reinsurance policies cost over £110,000 during the COPCOV trial, delayed trial approvals by up to nine months in some countries, and were largely justified by sponsors based on concerns about reputational damage. I argue that risk frameworks grounded in financial risk management and the commercial sector have expanded within academic institutions and, when coupled with an expansion of national requirements for "local paper" insurance policies, create serious barriers to initiating trial sites in many LMICs.<br />Conclusions: Two potential reform pathways, which are grounded in procedural or systemic reforms and should be led by LMIC-based policymakers, could help to de-barrier clinical trial insurance procedures and ensure that evidence of efficacious (and affordable) countermeasures are available during future global health emergencies.<br /> (© 2026. The Author(s).)
ISSN:1478-4505
DOI:10.1186/s12961-026-01449-6