TY - JOUR
T1 - Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov
T2 - A retrospective analysis
AU - Wildt, Signe
AU - Krag, Aleksander
AU - Gluud, Liselotte
PY - 2011/11/21
Y1 - 2011/11/21
N2 - Objectives: To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published trials. Methods: Randomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in http:// ClinicalTrials.gov were eligible for inclusion. From http://ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal Editors (ICMJE) member journals were extracted. The subsequent publications for registered trials were identified. For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted. Differences between primary and secondary outcomes, sample size and sample size calculations data in http://ClinicalTrials.gov and in the published paper were registered. Results: 105 trials were evaluated. 66 trials (63%) were published. 30% of trials were registered incorrectly after their completion date. Several data elements of the required ICMJE data list were not filled in, with missing data in 22% and 11%, respectively, of cases concerning the primary outcome measure and sample size. In 26% of the published papers, data on sample size calculations were missing and discrepancies between sample size reporting in http://ClinicalTrials.gov and published trials existed. Conclusion: The quality of registration of randomised controlled trials still needs improvement.
AB - Objectives: To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published trials. Methods: Randomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in http:// ClinicalTrials.gov were eligible for inclusion. From http://ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal Editors (ICMJE) member journals were extracted. The subsequent publications for registered trials were identified. For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted. Differences between primary and secondary outcomes, sample size and sample size calculations data in http://ClinicalTrials.gov and in the published paper were registered. Results: 105 trials were evaluated. 66 trials (63%) were published. 30% of trials were registered incorrectly after their completion date. Several data elements of the required ICMJE data list were not filled in, with missing data in 22% and 11%, respectively, of cases concerning the primary outcome measure and sample size. In 26% of the published papers, data on sample size calculations were missing and discrepancies between sample size reporting in http://ClinicalTrials.gov and published trials existed. Conclusion: The quality of registration of randomised controlled trials still needs improvement.
UR - http://www.scopus.com/inward/record.url?scp=81255129522&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2011-000309
DO - 10.1136/bmjopen-2011-000309
M3 - Article
C2 - 22080540
AN - SCOPUS:81255129522
VL - 1
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 2
M1 - e000309
ER -