Learning from failure--rationale and design for a study about discontinuation of randomized trials (DISCO study).

TitreLearning from failure--rationale and design for a study about discontinuation of randomized trials (DISCO study).
Publication TypeJournal Article
Year of Publication2012
AuthorsKasenda, B, von Elm, E, You, J, Blümle, A, Tomonaga, Y, Saccilotto, R, Amstutz, A, Bengough, T, Meerpohl, J, Stegert, M, Tikkinen, KAO, Neumann, I, Carrasco-Labra, A, Faulhaber, M, Mulla, S, Mertz, D, Akl, EA, Bassler, D, Busse, JW, Ferreira-Gonzalez, I, Lamontagne, F, Nordmann, A, Rosenthal, R, Schandelmaier, S, Sun, X, Vandvik, PO, Johnston, BC, Walter, MA, Burnand, B, Schwenkglenks, M, Bucher, HC, Guyatt, GH, Briel, M
JournalBMC Med Res Methodol
Volume12
Pagination131
Date Published2012
DOI10.1186/1471-2288-12-131
ISSN1471-2288
Mots-clésEthics Committees, Research, Humans, Informed Consent, Patient Selection, Randomized Controlled Trials as Topic, Research Design, Risk Factors, Treatment Failure
Abstract

BACKGROUND: Randomized controlled trials (RCTs) may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs) spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs.

METHODS/DESIGN: Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs.We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment.

DISCUSSION: Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials by investigators, Clinical Trial Units, RECs and funding agencies. Identification and modification of barriers to successful study completion at an early stage could help to reduce the risk of trial discontinuation, save limited resources, and enable RCTs to better meet their ethical requirements.

Alternate URL

http://www.ncbi.nlm.nih.gov/pubmed/22928744?dopt=Abstract

Alternate JournalBMC Med Res Methodol
Citation Key / SERVAL ID3300
PubMed ID22928744
PubMed Central IDPMC3528626
Grant List / / Canadian Institutes of Health Research / Canada

                         

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