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

Author

Kasenda, Benjamin, von Elm, Erik B., You, John, Blmle, Anette, Yuki Tomonaga, Saccilotto, Ramon, Amstutz, Alain, Bengough, Theresa, Meerpohl, J”rg, Stegert, Mihaela, Tikkinen, Kari A. O., Neumann, Ignacio, Carrasco-Labra, Alonso, Faulhaber, Markus, Mulla, Sohail, Mertz, Dominik, Akl, Elie A., Bassler, Dirk, Busse, Jason W., and Ferreira-Gonz lez, Ignacio

Subjects
*RANDOMIZED controlled trials, *CLINICAL medicine research, *MEDICAL experimentation on humans, *CLINICAL trials
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. [ABSTRACT FROM AUTHOR]

Published
2012
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3. Learning from Failure - Rationale and Design for a Study about Discontinuation of Randomized Trials (DISCO study)

Author

Yuki Tomonaga, Bernard Burnand, Jörg J. Meerpohl, Erik von Elm, Mihaela Stegert, Sohail M. Mulla, Heiner C. Bucher, Benjamin Kasenda, Bradley C. Johnston, Elie A. Akl, Xin Sun, Ramon Saccilotto, Dominik Mertz, Martin A. Walter, Kari A.O. Tikkinen, Matthias Schwenkglenks, Gordon H. Guyatt, Alain Amstutz, Anette Blümle, Dirk Bassler, Ignacio Ferreira-González, Stefan Schandelmaier, Matthias Briel, Jason W. Busse, Francois Lamontagne, Alonso Carrasco-Labra, Markus Faulhaber, Ignacio Neumann, Alain J Nordmann, John J. You, Per Olav Vandvik, Theresa Bengough, Rachel Rosenthal, University of Zurich, and Briel, Matthias

Subjects
Research design, medicine.medical_specialty, Learning from failure, Epidemiology, Alternative medicine, Health Informatics, 610 Medicine & health, 030204 cardiovascular system & hematology, law.invention, Study Protocol, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Risk Factors, Informed consent, law, Humans, Medicine, Treatment Failure, 030212 general & internal medicine, Trial discontinuation, Intensive care medicine, Randomized Controlled Trials as Topic, 2718 Health Informatics, lcsh:R5-920, Research ethics, Informed Consent, Slow recruitment, business.industry, Patient Selection, 10060 Epidemiology, Biostatistics and Prevention Institute (EBPI), 3. Good health, Discontinuation, Harm, Research Design, Ethics committees, Trial protocols, lcsh:Medicine (General), business, Ethics Committees, Research, Clinical psychology, 2713 Epidemiology
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.

Published
2012

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