title: Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.
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.
  
  
  METHODS
  Cohort embedded pragmatic randomized controlled trial.
  
  
  METHODS
  Trials registered on ClinicalTrials.gov.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Centre d'Epidémiologie Clinique, Université Paris Descartes-Sorbonne Paris Cité, INSERM U1153, Paris, France.
authors.forename: Annabel
authors.initials: A
authors.lastname: Maruani
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Centre d'Epidémiologie Clinique, Université Paris Descartes-Sorbonne Paris Cité, INSERM U1153, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boutron
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Centre d'Epidémiologie Clinique, Université Paris Descartes-Sorbonne Paris Cité, INSERM U1153, Paris, France.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Baron
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Centre d'Epidémiologie Clinique, Université Paris Descartes-Sorbonne Paris Cité, INSERM U1153, Paris, France Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, USA French Cochrane Centre, Paris, France philippe.ravaud@htd.aphp.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D034742:Electronic Mail; D006801:Humans; D017010:Reminder Systems; D016037:Single-Blind Method; D014481:United States; D014486:United States Food and Drug Administration