ArticleInternational journal of health services : planning, administration, evaluation2021
Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19.
Article in International journal of health services : planning, administration, evaluation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- International oncology drug approvals for multiregional or single-country clinical trials: A systematic review.Frontiers in medicine · 2022Pooled it
- Use of Statistics to Assess Serious Adverse Events in Clinical Trials of New Drugs: Cross-Sectional Study of FDA Review Memos.Journal of general internal medicine · 2026Article
- Considerations for prioritising clinical research using bacteriophage.Essays in biochemistry · 2024Review
- Decoding the impact of the placebo response in clinical trials for chronic cough.ERJ open research · 2024Article
- Decentralisation in Clinical Trials and Patient Centricity: Benefits and Challenges.Pharmaceutical medicine · 2024Review
- Pull me - push you? The disparate financing mechanisms of drug research in global health.Globalization and health · 2024Article
- Clinical study reports published by the European Medicines Agency 2016-2018: a cross-sectional analysis.BMJ open · 2023Article
- Characteristics of pivotal clinical trials of FDA-approved endovascular devices between 2000 and 2018: An interrupted time series analysis.Journal of clinical and translational science · 2023Article
- Anti-cancer drug combinations approved by US FDA from 2011 to 2021: main design features of clinical trials and role of pharmacokinetics.Cancer chemotherapy and pharmacology · 2022Review
- Combination therapies for COVID-19: An overview of the clinical trials landscape.British journal of clinical pharmacology · 2022Review
- Perceptions of Regulatory Decision-Making for New Drugs From the Viewpoints of the Manufacturers in South Korea.Frontiers in medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.