ArticleTrials2021
Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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
16 citing papers in PubMed.
- Evaluating the discoverability of supporting research materials in ClinicalTrials.gov for US federally funded COVID-19 clinical studies.Journal of the Medical Library Association : JMLA · 2024Article
- Evaluations of FDA-approved Drugs Targeting 3CLP of SARS-CoV-2 Employing a Repurposing Strategy.Combinatorial chemistry & high throughput screening · 2024Article
- [Optimisation of risk and crisis communication of governments, authorities and public health institutions-challenges in long-lasting crises illustrated by the COVID-19 pandemic].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2023Review
- Are European clinical trial funders policies on clinical trial registration and reporting improving? A cross-sectional study.Journal of clinical and translational science · 2023Article
- Adoption of World Health Organization Best Practices in Clinical Trial Transparency Among European Medical Research Funder Policies.JAMA network open · 2022Article
- Significant perspectives on various viral infections targeted antiviral drugs and vaccines including COVID-19 pandemicity.Molecular biomedicine · 2022Review
- Revealing the toxicity of lopinavir- and ritonavir-containing water and wastewater treated by photo-induced processes to Danio rerio and Allivibrio fischeri.The Science of the total environment · 2022Article
- Clinical Evidence Informing Treatment Guidelines on Repurposed Drugs for Hospitalized Patients During the Early COVID-19 Pandemic: Corticosteroids, Anticoagulants, (Hydroxy)chloroquine.Frontiers in public health · 2022Review
- Challenges and Lessons Learned From COVID-19 Trials: Should We Be Doing Clinical Trials Differently?The Canadian journal of cardiology · 2021Review
- COVID-19 vaccines and treatments: When speed is necessary and not enough.Clinical and translational science · 2021Article
- Article
- The Drug Repurposing for COVID-19 Clinical Trials Provide Very Effective Therapeutic Combinations: Lessons Learned From Major Clinical Studies.Frontiers in pharmacology · 2021Review
- COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective.Frontiers in medicine · 2021Article
- Patient and Citizen Participation in the Identification of Ethical Considerations Aiming to Address Uncertainty in the Evaluation of Promising Interventions in a Pandemic Context.Frontiers in medical technology · 2021Article
- Lessons Learned from Cutting-Edge Immunoinformatics on Next-Generation COVID-19 Vaccine Research.International journal of peptide research and therapeutics · 2021Article
- Characteristics of COVID-19 clinical trials registered with ClinicalTrials.gov: cross-sectional analysis.BMJ open · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSeveral drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable synthesis of existing safety data from clinical trials. However, availability of safety information is limited by a lack of timely reporting of overall clinical trial results on public registries or through academic publication. We aimed to analyse the evidence gap in this data by conducting a rapid review of results posting on ClinicalTrials.gov and in academic publications to quantify the number of trials missing results for drugs potentially being repurposed for COVID-19.
methodsClinicalTrials.gov was searched for 19 drugs that have been identified as potential treatments for COVID-19. Relevant clinical trials for any prior indication were listed by identifier (NCT number) and checked for results and for timely result reporting (within 395 days of the primary completion date). Additionally, PubMed and Google Scholar were searched to identify publications of results not listed on the registry. A second, blinded search of 10% of trials was conducted to assess reviewer concordance.
resultsOf 3754 completed trials, 1516 (40.4%) did not post results on ClinicalTrials.gov or in the academic literature. Tabular results were available on ClinicalTrials.gov for 1172 (31.2%) completed trials. A further 1066 (28.4%) had published results in the academic literature, but did not report results on ClinicalTrials.gov . Key drugs missing clinical trial results include hydroxychloroquine (37.0% completed trials unreported), favipiravir (77.8%) and lopinavir (40.5%).
conclusionsThere is an important evidence gap for the safety of drugs being repurposed for COVID-19. This uncertainty could cause unnecessary additional morbidity and mortality during the pandemic. We recommend caution in experimental drug use for non-severe disease and urge clinical trial sponsors to report missing results retrospectively.
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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.