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.

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 Clinica

SUBMITTER: Maruani A 

PROVIDER: S-EPMC4168816 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature