An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules
| Autor: | Mihaela Stegert, Benjamin Kasenda, Erik von Elm, John J. You, Anette Blümle, Yuki Tomonaga, Ramon Saccilotto, Alain Amstutz, Theresa Bengough, Matthias Briel, Joerg J. Meerpohl, Kari A.O. Tikkinen, Ignacio Neumann, Alonso Carrasco-Labra, Markus Faulhaber, Sohail Mulla, Dominik Mertz, Elie A. Akl, Dirk Bassler, Jason W. Busse, Ignacio Ferreira-González, Francois Lamontagne, Alain Nordmann, Viktoria Gloy, Kelechi Kalu Olu, Heike Raatz, Lorenzo Moja, Rachel Rosenthal, Shanil Ebrahim, Stefan Schandelmaier, Xin Sun, Per O. Vandvik, Bradley C. Johnston, Martin A. Walter, Bernard Burnand, Matthias Schwenkglenks, Lars G. Hemkens, Heiner C. Bucher, Gordon H. Guyatt |
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| Přispěvatelé: | University of Zurich, Briel, Matthias |
| Předmět: |
medicine.medical_specialty
Epidemiology 610 Medicine & health computer.software_genre 01 natural sciences law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Clinical Protocols law Interim medicine Data monitoring committee 030212 general & internal medicine 0101 mathematics Intensive care medicine Randomized Controlled Trials as Topic Protocol (science) business.industry 010102 general mathematics 10060 Epidemiology Biostatistics and Prevention Institute (EBPI) 10027 Clinic for Neonatology Interim analysis 3. Good health Discontinuation Clinical trial Cohort Early Termination of Clinical Trials Data mining Periodicals as Topic business Clinical Trials Data Monitoring Committees computer 2713 Epidemiology |
| Zdroj: | Journal of Clinical Epidemiology |
| DOI: | 10.1016/j.jclinepi.2015.05.023 |
| Popis: | Objectives To investigate the frequency of interim analyses, stopping rules, and data safety and monitoring boards (DSMBs) in protocols of randomized controlled trials (RCTs); to examine these features across different reasons for trial discontinuation; and to identify discrepancies in reporting between protocols and publications. Study Design and Setting We used data from a cohort of RCT protocols approved between 2000 and 2003 by six research ethics committees in Switzerland, Germany, and Canada. Results Of 894 RCT protocols, 289 prespecified interim analyses (32.3%), 153 stopping rules (17.1%), and 257 DSMBs (28.7%). Overall, 249 of 894 RCTs (27.9%) were prematurely discontinued; mostly due to reasons such as poor recruitment, administrative reasons, or unexpected harm. Forty-six of 249 RCTs (18.4%) were discontinued due to early benefit or futility; of those, 37 (80.4%) were stopped outside a formal interim analysis or stopping rule. Of 515 published RCTs, there were discrepancies between protocols and publications for interim analyses (21.1%), stopping rules (14.4%), and DSMBs (19.6%). Conclusion Two-thirds of RCT protocols did not consider interim analyses, stopping rules, or DSMBs. Most RCTs discontinued for early benefit or futility were stopped without a prespecified mechanism. When assessing trial manuscripts, journals should require access to the protocol. |
| Databáze: | OpenAIRE |
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