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J Clin Epidemiol. 2016 Feb;70:176-82. doi: 10.1016/j.jclinepi.2015.09.009. Epub 2015 Sep 18.

Registration practices for observational studies on ClinicalTrials.gov indicated low adherence.

Author information

1
Section of Hygiene, Institute of Public Health, Università Cattolica del Sacro Cuore, L.go F. Vito, 1, Rome 00168, Italy. Electronic address: sboccia@rm.unicatt.it.
2
RTI Health Solutions, Research Triangle Institute, Research Triangle Park, NC, USA; Department of Epidemiology, Boston University School of Public Health, Boston, MA, USA.
3
Section of Hygiene, Institute of Public Health, Università Cattolica del Sacro Cuore, L.go F. Vito, 1, Rome 00168, Italy.
4
Department of Medicine and Aging Sciences, University of Chieti, Via dei Vestini 5, 66013 Chieti, Italy; ASL Pescara, Via Renato Paolini 47, Pescara 65123, Italy.
5
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Piazzale Aldo Moro 5, Rome 00185, Italy.
6
Department of Medicine and Aging Sciences, University of Chieti, Via dei Vestini 5, 66013 Chieti, Italy; CeSI Biotech, Via Colle dell'Ara, Chieti 66100, Italy.
7
Department of Clinical Sciences and Community Health, University of Milan, Via Vanzetti 5, 20133, Milan, Italy.
8
Population Sciences, Tisch Cancer Center and Institute for Translational Epidemiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
9
Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA; Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA; Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, CA, USA; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, CA, USA.

Abstract

OBJECTIVE:

The study aims to assess the status of registration of observational studies.

STUDY DESIGN AND SETTING:

We identified studies on cancer research with prospective recruitment of participants that were registered from February 2000 to December 2011 in ClinicalTrials.gov. We recorded the dates of registration and start of recruitment, outcomes, and description of statistical method. We searched for publications corresponding to the registered studies through May 31, 2014.

RESULTS:

One thousand one hundred nine registered studies were eligible. Primary and secondary outcomes were reported in 809 (73.0%) and 464 (41.8%) of them. The date of registration preceded the month of the study start in 145 (13.8%) and coincided in 205 (19.5%). A total of 151 publications from 120 (10.8%) registered studies were identified. In 2 (33.3%) of the 6 publications where ClinicalTrials.gov reported that the study started recruitment after registration, and in 9 (50.0%) of 18 publications where ClinicalTrials.gov reported the same date for registration and start of recruitment, the articles showed that the study had actually started recruiting before registration.

CONCLUSION:

During the period reviewed, few observational studies have been registered. Registration usually occurred after the study started, and prespecification of outcomes and statistical analysis rarely occurred.

KEYWORDS:

Cancer protocol registration; ClinicalTrials.gov; Outcome reporting bias; Protocol registration; Registration of observational studies; Registration study records

PMID:
26386325
DOI:
10.1016/j.jclinepi.2015.09.009
[Indexed for MEDLINE]

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