Trial Approvals Face Delays During COVID-19 Pandemic

Trial Approvals Face Delays During COVID-19 Pandemic

Publication date: Dec 20, 2025

Trial approvals were also heavily influenced by external factors, and ECs and national drug regulatory authorities continued to cite a retracted paper for 2 years post-retraction. They also found that the median time for an initial decision was 104 days, with the initial protocol being under consideration for 3886 aggregated days in all participating countries. The trial was a double-blind, randomized, placebo-controlled trial conducted in health care settings and other facilities. The authors of a study published in Trials said that many multicountry COVID-19 trials were quickly conceptualized without influencing the treatment guidelines. In the COPCOV trial ( NCT04303507 ), investigators aimed to determine the efficacy of hydroxychloroquine and chloroquine as a prophylaxis for COVID-19. Further, the protocol was submitted to 22 local ethics committees (ECs) and institutional review boards, 19 national ECs, and 14 national regulatory authorities. Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips straight to your inbox. REFERENCES1.

Concepts Keywords
Clinicaltrials Approvals
Coronavirus Chloroquine
Dangerous Copcov
December Countries
Italy Covid
Days
Delays
Drug
Ecs
Hydroxychloroquine
Investigators
National
Regulatory
Trial
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Semantics

Type Source Name
pathway KEGG Coronavirus disease
drug DRUGBANK Nonoxynol-9
disease MESH included
disease MESH emergencies
drug DRUGBANK Chloroquine
drug DRUGBANK Hydroxychloroquine
disease MESH COVID-19 Pandemic
disease MESH Face

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