Whose data set is it anyway? Sharing raw data from randomized trials Journal Article


Author: Vickers, A. J.
Article Title: Whose data set is it anyway? Sharing raw data from randomized trials
Abstract: Background: Sharing of raw research data is common in many areas of medical research, genomics being perhaps the most well-known example. In the clinical trial community investigators routinely refuse to share raw data from a randomized trial without giving a reason. Discussion: Data sharing benefits numerous research-related activities: reproducing analyses; testing secondary hypotheses; developing and evaluating novel statistical methods; teaching; aiding design of future trials; meta-analysis; and, possibly, preventing error, fraud and selective reporting. Clinical trialists, however, sometimes appear overly concerned with being scooped and with misrepresentation of their work. Both possibilities can be avoided with simple measures such as inclusion of the original trialists as co-authors on any publication resulting from data sharing. Moreover, if we treat any data set as belonging to the patients who comprise it, rather than the investigators, such concerns fall away. Conclusion: Technological developments, particularly the Internet, have made data sharing generally a trivial logistical problem. Data sharing should come to be seen as an inherent part of conducting a randomized trial, similar to the way in which we consider ethical review and publication of study results. Journals and funding bodies should insist that trialists make raw data available, for example, by publishing data on the Web. If the clinical trial community continues to fail with respect to data sharing, we will only strengthen the public perception that we do clinical trials to benefit ourselves, not our patients. © 2006 Vickers; licensee BioMed Central Ltd.
Keywords: note; methodology; reproducibility; internet; teaching; publication; statistical analysis; systematic review; medical technology; data analysis; clinical research; medical literature; analytical error; research ethics; data collection method; hypothesis; public opinion; health care financing; forgery
Journal Title: Trials
Volume: 7
ISSN: 1745-6215
Publisher: Biomed Central Ltd  
Date Published: 2006-05-16
Start Page: 15
Language: English
DOI: 10.1186/1745-6215-7-15
PROVIDER: scopus
PMCID: PMC1489946
PUBMED: 16704733
DOI/URL:
Notes: --- - "Cited By (since 1996): 25" - "Export Date: 4 June 2012" - "Source: Scopus"
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  1. Andrew J Vickers
    883 Vickers