Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov

BMC Musculoskeletal Disorders

Mohit Bhandari³  Nizar N Mahomed⁴  Holly N Smith¹  Meryam Jan¹  Rajiv Gandhi² 

[1] Toronto Western Hospital EW 1-433, 399 Bathurst Street, Toronto, ON M5T 2S8, Canada;Toronto Western Hospital EW 1-439, 399 Bathurst Street, Toronto, ON M5T 2S8, Canada;Hamilton General Hospital, 7 North, Suite 727 237 Barton St East, Hamilton, ON L8L 2X2, Canada;Toronto Western Hospital EW 1-435, 399 Bathurst Street, Toronto, ON M5T 2S8, Canada

关键词: Orthopaedic trauma;    Clinicaltrials.gov;    Trial registration;   

Others  :  1151076
DOI  :  10.1186/1471-2474-12-278

 received in 2011-06-09, accepted in 2011-12-07,  发布年份 2011

【 摘 要 】

Background

After the Food and Drug Administration Modernization Act of 1997, the registration of all clinical trials became mandatory prior to publication. Our primary objective was to determine publication rates for orthopaedic trauma trials registered with ClinicalTrials.gov. We further evaluated methodological consistency between registration and publication.

Methods

We searched Clinical Trials.gov for all trials related to orthopaedic trauma. We excluded active trials and trials not completed by July 2009, and performed a systematic search for publications resulting from registered closed trials. Information regarding primary and secondary outcomes, intervention, study sponsors, and sample size were extracted from registrations and publications.

Results

Of 130 closed trials, 37 eligible trials resulted in 16 publications (43.2%). We found no significant differences in publication rates between funding sources for industry sponsored studies and nongovernment/nonindustry sponsored studies (p > 0.05). About half the trials (45%) did not include the NCT ID in the publication. Two (10%) publications had major changes to the primary outcome measure and ten (52.6%) to sample size.

Conclusions

Registration of orthopaedic trauma trials does not consistently result in publication. When trials are registered, many do not cite NCT ID in the publication. Furthermore, changes that are not reflected in the registry of the trial are frequently made to the final publication.

【 授权许可】

   
2011 Gandhi et al; licensee BioMed Central Ltd.

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