Clinical Trials Results Reporting Improved with Email Reminders

BMJ last month posted a research article that shows researchers are more likely to post the results of their trials if they are sent an email reminder. Since 2007, the FDA has required registration of clinical trials conducted in the United States on ClinicalTrials.gov before they begin and to post summary results within one year of completion of the trial. However, about 75% of trials on ClinicalTrials.gov haven’t reported results. The BMJ study focused on Phase IV trials that were closed for recruitment with at least one site in the United States. The experimental intervention "consisted of sending reminders of the FDAAA 801 requirement through personalized emails to responsible parties of the randomly selected trials. The emails were constructed as surveys, notifying responsible parties of trials that the primary completion date was over a year old and asking for the reasons why they had not posted results on the register (see supplementary appendix). In fact the survey was a “cover” for the reminder." At three months, 19% trials in the intervention group had posted results versus 13% in the control group. At six months, 24% trials in the intervention group had posted results versus 14% in the control group.

Read the full report here.