Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial
BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5579 (Published 19 September 2014) Cite this as: BMJ 2014;349:g5579
- Annabel Maruani, professor1,
- Isabelle Boutron, professor1,
- Gabriel Baron, statistician1,
- Philippe Ravaud, professor 13, director2
- 1Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Centre d’Epidémiologie Clinique, Université Paris Descartes-Sorbonne Paris Cité, INSERM U1153, Paris, France
- 2French Cochrane Centre, Paris, France
- 3Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, USA
- Correspondence to: P Ravaud, AP-HP, Hôpital Hôtel-Dieu, Centre d’Epidémiologie Clinique, Université Paris Descartes-Sorbonne Paris Cité, INSERM U1153, 1, Place du Parvis de Notre-Dame, 75181 Paris Cedex 04, France philippe.ravaud{at}htd.aphp.fr
- Accepted 29 August 2014
Abstract
Objective To 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.
Design Cohort embedded pragmatic randomized controlled trial.
Setting Trials registered on ClinicalTrials.gov.
Participants 190 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 measures The 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.
Results Among 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).
Conclusions Sending 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.
Footnotes
Contributors: AM, IB, and PR conceived and designed the study. IB and PR supervised the study. All authors drafted the manuscript, critically revised the manuscript for important intellectual content, had full access to all of the data in the study, and take responsibility for the integrity of the data and the accuracy of the data analysis. PR is the guarantor.
Funding: This study received no funding.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisation that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This trial was approved by the institutional review board of Paris-Descartes, Ile de France II, France on 23 July 2012 (registration No 00001072).
Data sharing: No additional data available.
Transparency: The guarantor (PR) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.