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Country Contribution to Investigators of Pivotal Clinical Trials and Their Primary Publications of New Drugs Approved by the US Food and Drug Administration, 2012–2021

Year: 2025

Type: article

Abstract: Background: Pivotal clinical trials (PCTs) are often conducted across multiple nations and regions to achieve geographic, racial, or ethnic diversity. However, the racial and ethnic diversity of PCT participants still remains inadequate.Methods: PCTs for new drugs approved by the US Food and Drug Administration from 2012 to 2021 and their primary publications (PPub) were identified from the label and review documents. The country information about the PCT investigators and PPub authors were extracted from the PPubs or clinicaltrials.gov. The racial/ethnic diversity of PCT participants as reported in PPubs was assessed using the Diversity Index (DI). The association between the racial/ethnic diversity of PCT participants and the geographic distribution of PCT investigators and PPub authors was evaluated using logistic regression.Findings: For 429 new drugs, 734 PCTs and 678 PPubs were identified. North America and Western Europe (NAWE) contributed the largest proportion of PCT investigators, PPub authors, and lead authors (62.9%, 81.7%, and 90.9%, respectively). Of 521 PPubs that reported the racial/ethnic distribution of PCT participants, the median DI was low at 0.33 (interquartile range 0.18–0.46) and only 16.3% PPubs had a DI >0.5. The number of PPub authors in non-NAWE and the number of countries of PPub authors in non-NAWE was significantly associated with the racial/ethnic diversity of PCT participants (OR 1.17 [95% CI 1.08–1.26] and OR 1.25 [1.08–1.46], respectively).Interpretation: Evidence generation for the regulatory approval of new drugs has been predominantly centered in NAWE. The dominance is even more pronounced in the authorship of PPubs. To improve the racial/ethnic diversity of PCT participants, investigators from non-NAWE countries should be encouraged to play more leadership roles, thereby increasing their likelihood of serving as authors in PPub.Funding: The BK21FOUR Program of the National Research Foundation of Korea

Source: Clinical Pharmacology & Therapeutics

DOI: 10.1002/cpt.3589

Authors: Yoona Choi, Jung‐Hyun Won, Heeju Kim, YeSol Hong, Yujin Kim, Howard Lee

Institutions: Seoul National University, Seoul National University Hospital, Advanced Institute of Convergence Technology

Language: English

Topic: Pharmaceutical industry and healthcare

Subfield: Pharmacology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDGs: Good health and well-being, Reduced inequalities

Open Access status: hybrid

Estimated APC paid: $4,410