Posting of Basic Results of Clinical Trials

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 1, 2012

Keywords

ClinConnect Summary

According to the recommendation of 2005 by International Committee of Medical Journal Editors (ICMJE), clinical trials must be registered before enrolment of the first patient in a free registry recognized by the World Health Organization (WHO). The goal is to improve transparency of clinical research. The ClinicalTrials.gov trial registry, initiated subsequently to the US Food and Drug Administration Modernization Act (FDAMA) in 1997, is the widest used registry, and contains more than 121 000 studies located in 179 countries (data of March 1, 2012).

The gap between the high number of reg...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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• • Studies which are either withdrawn or suspended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