Posting of Basic Results of Clinical Trials

NCT01658254 | Completed

• 1 other identifier: PR 738
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 1

Brief Summary

The gap between the high number of registered trials and the few ones where results were available (in registries or in journals) has been identified as a major problem distorting the scientific evidence available. As a consequence, the FDAAA (Food and Drug Administration Amendments Act) added on September 27, 2007 a requirements policy regarding publication of summary results on the publicly accessible registry ClinicalTrials.gov. Reporting of summary results is required for "applicable clinical trials" no later than one year after the "primary completion date", i.e. the date of collection of primary outcome data on the last patient to be enrolled. 'Applicable clinical trials', is the term used in the FDAAA to designate trials that may be subject to the registration and reporting requirements. Not complying with the reporting requirements can result in penalties, such as withholding of National Institute of Health grant or funding and civil monetary penalties of up to $10,000 a day. Despite the possibility of incurring penalties for not complying with the posting requirement, compliance remains globally poor. In this current study, the primary objective will be to test the hypothesis that sending an email looking as a survey, reminding the necessity of posting results to the trials' responsible parties registered in ClinicalTrials.gov and subject to mandatory reporting but not complying with it, will increase the results posting rate.

Conditions

The Study Will Focus on no Specific Conditions

Keywords

Clinical trials; Basic results; Registry

Outcome Measures

Primary Outcomes (1)

• The proportions of trials with posted results at 90 days will be compared using a chi-square test to the control group.

  Primary endpoint: the proportions of trials with posted results on the registry at 90 days will be compared to the control group using a chi-square test.

  90 days

Secondary Outcomes (1)

• The proportions of trials with posted results on the registry at 180 days will be compared to the control group using a chi-square test.

  180 days

Study Arms (2)

Survey by email

EXPERIMENTAL

One arm of investigators will receive the survey to answer by email, reminding the necessity of posting basic results

Other: survey by email

Non interventional arm

NO INTERVENTION

This arm will receive no intervention (no email with the survey)

Interventions

survey by email OTHER

The intervention consists in an email to be sent to the sponsor and/or principal investigator of randomly assigned trials. This email will notify them that their trial's primary completion date is over a year old and will ask the reasons why they have not posted results on the registry. Several reasons will be proposed, and investigators or sponsors will be asked to reply by sending back an email or through a website where the same questions will appear. A follow-up email will systematically be sent 7 days after, with similar content (appendix2). The emails will be sent as direct emails, without attached files, with the edit subject "Posting basic results". The controlled group will receive no intervention.

Survey by email

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Interventional studies of drugs, biological or devices
• Studies which are closed and either completed or active but not recruiting anymore
• Studies with at least one site in the USA
• Studies registered as phase IV
• Studies with a primary completion date or, if missing, a completion date ranging from October 2008 to January 2011
• Studies without posted results on the registry

You may not qualify if:

• Studies which are still recruiting
• Studies which are either withdrawn or suspended
• Studies which primary completion date is less than one year
• Studies without a given primary completion date or completion date
• Studies involving interventions which are neither drugs or biologics nor devices will be excluded
• Studies whose summary results are posted
• Studies without indication on the sponsor or the principal investigator
• Studies whom email address of the sponsor or the principal investigator could not be found in a publicly accessible site

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Clinical Epidemiology Center, Hotel-Dieu

Paris, 75004, France

Location

Related Publications (1)

• Maruani A, Boutron I, Baron G, Ravaud P. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial. BMJ. 2014 Sep 19;349:g5579. doi: 10.1136/bmj.g5579.

  PMID: 25239625 DERIVED

Study Officials

• Philippe Ravaud, MD, PhD

  Hotel-Dieu, Clinical Epidemiology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: August 6, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 30, 2014

Record last verified: 2012-06

Locations

FR (1)