Trial reportBMJ (Clinical research ed.)2014
Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.
Trial report in BMJ (Clinical research ed.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01658254 (A Cohort Randomized Controlled Trial Evaluating the Effect of Sending a Reminder to Responsible Parties of Clinical Trials in the Posting of Basic Results Onto ClinicalTrials.Gov), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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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.
A Cohort Randomized Controlled Trial Evaluating the Effect of Sending a Reminder to Responsible Parties of Clinical Trials in the Posting of Basic Results Onto ClinicalTrials.Gov
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Results of trials assessing transarterial chemoembolization for treating hepatocellular carcinoma are critically underreported.European radiology · 2020Pooled it
- Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses.BMJ (Clinical research ed.) · 2017Pooled it
- Improving research transparency with individualized report cards: A feasibility study in clinical trials at a large university medical center.BMC medical research methodology · 2025Article
- Reporting of interventional clinical trial results in an academic center: a survey of completed studies.BMC medical research methodology · 2024Article
- Randomised trials conducted using cohorts: a scoping review.BMJ open · 2024Article
- Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years.The oncologist · 2022Article
- Interventions for improving the design and conduct of scientific research: A scoping review protocol.NIHR open research · 2022Article
- Results Reporting and Early Termination of Childhood Obesity Trials Registered on ClinicalTrials.gov.Frontiers in pediatrics · 2022Article
- Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications-a methodological review.BMC medicine · 2021Article
- The COVID-NMA Project: Building an Evidence Ecosystem for the COVID-19 Pandemic.Annals of internal medicine · 2020Article
- Delays in the Publication of Important Clinical Trial Findings in Oncology.JAMA oncology · 2018Review
- Clinical trial registration and reporting: a survey of academic organizations in the United States.BMC medicine · 2018Article
- Reporting of statistically significant results at ClinicalTrials.gov for completed superiority randomized controlled trials.BMC medicine · 2016Article
- Article
- Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.BMC medicine · 2016Article
- Wasted research when systematic reviews fail to provide a complete and up-to-date evidence synthesis: the example of lung cancer.BMC medicine · 2016Article
- Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles.BMC medicine · 2015Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results.
designCohort embedded pragmatic randomized controlled trial.
settingTrials registered on ClinicalTrials.gov.
participants190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance).
main outcome measuresThe primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed.
resultsAmong 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001).
conclusionsSending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254.
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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.