More information on trial site investigators needed

December 27, 2011

Despite the importance of site investigators to the success of multicentre clinical trials, inadequate public information is available about their recruitment performance. In this week's PLoS Medicine, Rafael Dal-Ré and colleagues argue that that sponsors should disclose the recruitment targets of all site investigators on ClinicalTrials.gov before a trial starts, as well as their final recruitment. Information on issues that could have affected recruitment should also be provided. This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks, say the authors.

The authors state that: "Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to be able to assess if ethnic or standard-of-care differences have an impact on treatment outcomes."
-end-
Funding: The authors received no specific funding for this article. Dr. D Moher is funded, in part, by a University Research Chair (University of Ottawa, Canada).

Competing Interests: RDR reports being a GlaxoSmithKline employee (as Medical Director in Spain) until 2009 and owning stock in this firm. XC is the chairperson of the Spanish Commmittee of Drug Evaluation, an external advisory board to the Spanish Medicines Agency (AEMPS). DM is a member of the PLoS Medicine Editorial Board. The ideas and opinions expressed here are those of the authors and do not necessarily reflect those of the institutions or organizations they work for. All other authors reported having no competing interests.

Citation: Dal-Ré R, Moher D, Gluud C, Treweek S, Demotes-Mainard J, et al. (2011) Disclosure of Investigators' Recruitment Performance in Multicenter Clinical Trials: A Further Step for Research Transparency. PLoS Med 8(12): e1001149. doi:10.1371/journal.pmed.1001149

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001149

PRESS-ONLY PREVIEW OF THE ARTICLE: www.plos.org/media/press/2011/plme-08-12-dal-re.pdf

CONTACT:
Rafael Dal-Ré
Early Detection Research Program
Alzheimer's Disease
Pasqual Maragall Foundation
Barcelona
Spain
+34649410221
rfdalre@gmail.com; rdal-re@fpmaragall.org

PLOS

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