Artículo de revista
Prevalence, Characteristics, and Publication of Discontinued Randomized Trials
Fecha
2014Registro en:
Jama. 2014;311(10):1045-1051.
doi:10.1001/jama.2014.1361
Autor
Kasenda, Benjamin
Von Elm, Erik
You, John
Blümle, Anette
Tomonaga, Yuki
Saccilotto, Ramón
Amstutz, Alain
Bengough, Theresa
Meerpohl, Joerg J.
Stegert, Mihaela
Tikkinen, Kari A. O.
Neumann, Ignacio
Carrasco Labra, Alonso
Faulhaber, Markus
Mulla, Sohail M.
Mertz, Dominik
Akl, Elie A.
Bassler, Dirk
Busse, Jason W.
Ferreira González, Ignacio
Lamontagne, Francois
Nordmann, Alain
Gloy, Viktoria
Raatz, Heike
Moja, Lorenzo
Rosenthal, Rachel
Ebrahim, Shanil
Schandelmaier, Stefan
Xin, Sun
Vandvik, Per O.
Johnston, Bradley C.
Walter, Martin A.
Burnand, Bernard
Schwenkglenks, Matthias
Hemkens, Lars G.
Bucher, Heiner C.
Guyatt, Gordon H.
Briel, Matthias
Institución
Resumen
IMPORTANCE The discontinuation of randomized clinical trials (RCTs) raises ethical concerns
and often wastes scarce research resources. The epidemiology of discontinued RCTs,
however, remains unclear.
OBJECTIVES To determine the prevalence, characteristics, and publication history of
discontinued RCTs and to investigate factors associated with RCT discontinuation due to poor
recruitment and with nonpublication.
DESIGN AND SETTING Retrospective cohort of RCTs based on archived protocols approved by
6 research ethics committees in Switzerland, Germany, and Canada between 2000 and
2003.We recorded trial characteristics and planned recruitment from included protocols.
Last follow-up of RCTs was April 27, 2013.
MAIN OUTCOMES AND MEASURES Completion status, reported reasons for discontinuation,
and publication status of RCTs as determined by correspondence with the research ethics
committees, literature searches, and investigator surveys.
RESULTS After a median follow-up of 11.6 years (range, 8.8-12.6 years), 253 of 1017 included
RCTs were discontinued (24.9% [95%CI, 22.3%-27.6%]). Only 96 of 253 discontinuations
(37.9% [95%CI, 32.0%-44.3%]) were reported to ethics committees. The most frequent
reason for discontinuation was poor recruitment (101/1017; 9.9%[95%CI, 8.2%-12.0%]). In
multivariable analysis, industry sponsorship vs investigator sponsorship (8.4%vs 26.5%;
odds ratio [OR], 0.25 [95%CI, 0.15-0.43]; P < .001) and a larger planned sample size in
increments of 100 (-0.7%; OR, 0.96 [95%CI, 0.92-1.00]; P = .04) were associated with
lower rates of discontinuation due to poor recruitment. Discontinued trials were more likely
to remain unpublished than completed trials (55.1%vs 33.6%; OR, 3.19 [95%CI, 2.29-4.43];
P < .001).
CONCLUSIONS AND RELEVANCE In this sample of trials based on RCT protocols from 6
research ethics committees, discontinuation was common, with poor recruitment being the
most frequently reported reason. Greater efforts are needed to ensure the reporting of trial
discontinuation to research ethics committees and the publication of results of discontinued
trials.