Trial Registration at ClinicalTrials.gov between May and October 2005
- 29 December 2005
- journal article
- research article
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 353 (26) , 2779-2787
- https://doi.org/10.1056/nejmsa053234
Abstract
Clinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration process. We used information in the publicly available ClinicalTrials.gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication. We reviewed ClinicalTrials.gov records to determine patterns of completion of the “Intervention Name” and “Primary Outcome Measure” data fields for trials registered on May 20 and October 11, 2005, and for trials registered during the interval between these two dates, inclusively. During the interval studied, the number of registrations in ClinicalTrials.gov increased by 73 percent from 13,153 to 22,714. The percentage of interventional trials registered by industry with nonspecific Intervention Name entries (attributable to four drug companies) decreased from 10 percent to 2 percent; all other industry and nonindustry records contained specific entries in this field. Of the 2670 studies registered by industry between the two dates, 76 percent provided information in the Primary Outcome Measure field, although these entries varied markedly in their degree of specificity. In the remaining 24 percent of the records, this field was blank. During the summer of 2005, there were large increases in the number of clinical trial registrations. Overall, the data contained in records were more complete in October than they were in May, but there still is room for substantial improvement.Keywords
This publication has 13 references indexed in Scilit:
- Is This Clinical Trial Fully Registered? — A Statement from the International Committee of Medical Journal EditorsNew England Journal of Medicine, 2005
- Clinical Trials and Public TrustScience, 2004
- Registration of Clinical Trials — Voluntary or Mandatory?New England Journal of Medicine, 2004
- The Society for Clinical Trials supports United States legislation mandating trials registrationClinical Trials, 2004
- Clinical Trial Registration: A Statement from the International Committee of Medical Journal EditorsNew England Journal of Medicine, 2004
- Trial RegistrationJAMA, 2004
- Registering clinical trials: an essential role for WHOThe Lancet, 2004
- Design, implementation and management of a web-based data entry system for ClinicalTrials.gov.2004
- The Unified Medical Language System (UMLS): integrating biomedical terminologyNucleic Acids Research, 2004
- Registering Clinical TrialsJAMA, 2003