Prevalence, characteristics, and publication of discontinued randomized trials

JAMA

Volumn 311, Issue 10, 2014, Pages 1045-1051

  Kasenda, Benjamin ^a   Von Elm, Erik ^b   You, John ^c   Blümle, Anette ^d   Tomonaga, Yuki ^e   Saccilotto, Ramon ^a   Amstutz, Alain ^a   Bengough, Theresa ^b   Meerpohl, Joerg J ^d   Stegert, Mihaela ^a   Tikkinen, Kari A O ^c,n   Neumann, Ignacio ^c,o   Carrasco Labra, Alonso ^c,u   Faulhaber, Markus ^c   Mulla, Sohail M ^c   Mertz, Dominik ^c,v   Akl, Elie A ^c,p,q   Bassler, Dirk ^f   Busse, Jason W ^c,v   Ferreira González, Ignacio ^g   Lamontagne, Francois ^h   Nordmann, Alain ^a   Gloy, Viktoria ^a,m   Raatz, Heike ^a   Moja, Lorenzo ⁱ   Rosenthal, Rachel ^j   Ebrahim, Shanil ^c,r   Schandelmaier, Stefan ^a,j   Xin, Sun ^c,s   Vandvik, Per O ^k   Johnston, Bradley C ^c,l,t   Walter, Martin A ^m   Burnand, Bernard ^b   Schwenkglenks, Matthias ^e   Hemkens, Lars G ^a   Bucher, Heiner C ^a   Guyatt, Gordon H ^c   Briel, Matthias ^a,c   more..

^a UNIVERSITY HOSPITAL BASEL   (Switzerland)

^b UNIVERSITY OF LAUSANNE   (Switzerland)

^c MCMASTER UNIVERSITY   (Canada)

^d UNIVERSITY OF FREIBURG   (Germany)

^e UNIVERSITY OF ZURICH   (Switzerland)

^f UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^g HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^h Centre Hospitalier Universitaire de Sherbrooke   (Canada)

ⁱ IRCCS ISTITUTO ORTOPEDICO GALEAZZI   (Italy)

^j UNIVERSITY HOSPITAL BASEL   (Switzerland)

^k INNLANDET HOSPITAL TRUST   (Norway)

^l HOSPITAL FOR SICK CHILDREN   (Canada)

^m UNIVERSITY OF BERN   (Switzerland)

ⁿ HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^o PONTIFICIA UNIVERSIDAD CATÓLICA DE CHILE   (Chile)

^p AMERICAN UNIVERSITY OF BEIRUT   (Lebanon)

^q UNIVERSITY AT BUFFALO   (United States)

^r STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^s SICHUAN UNIVERSITY   (China)

^t UNIVERSITY OF TORONTO   (Canada)

^u UNIVERSITY OF CHILE   (Chile)

^v MCMASTER UNIVERSITY   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; COHORT ANALYSIS; DATA PROCESSING; DISCONTINUED RANDOMIZED CLINICAL TRIAL; FOLLOW UP; HEALTH CARE DELIVERY; HUMAN; PATIENT COMPLIANCE; PATIENT SELECTION; PREVALENCE; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; RETROSPECTIVE STUDY;

CANADA; COHORT STUDIES; ETHICS COMMITTEES, RESEARCH; GERMANY; HUMANS; ODDS RATIO; PATIENT SELECTION; PUBLICATION BIAS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; SWITZERLAND;

EID: 84896800584     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2014.1361     Document Type: Article

References (22)

1. De Angelis C, Drazen JM, Frizelle FA, et al International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292(11):1363- 1364. (Pubitemid 39223230)
2. Campbell MK, Snowdon C, Francis D, et al STEPS Group. Recruitment to randomised trials: strategies for trial enrollment and participation study. Health Technol Assess. 2007;11(48):iii; ix-105.
3. Kasenda B, von Elm EB, You J, et al. Learning from failure-rationale and design for a study about discontinuation of randomized trials (DISCO study). BMC Med ResMethodol. 2012;12(1):131.
4. McDonald AM, Knight RC, Campbell MK, et al. What influences recruitment to randomised controlled trials? Trials. 2006;7:9.
5. Schroen AT, Petroni GR, Wang H, et al. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials. Clin Trials. 2010;7(4):312-321.
6. Damen L, van Agt F, de Boo T, Huysmans F. Terminating clinical trials without sufficient subjects. J Med Ethics. 2012;38(7):413-416.
7. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. International Conference on Harmonisation website. http://www.ich.org/fileadmin/Public-Web-Site/ICH- Products/Guidelines/Efficacy/E6-R1/Step4/E6-R1--Guideline.pdf. 1996. Accessed February 12, 2014.
8. von Elm E, Röllin A, Blümle A, Huwiler K, Witschi M, Egger M. Publication and non-publication of clinical trials. Swiss Med Wkly. 2008;138(13-14):197-203.
9. Kenward MG, Carpenter J. Multiple imputation: current perspectives. Stat Methods Med Res. 2007;16(3):199-218. (Pubitemid 47018659)
10. Dwan K, Gamble C, Williamson PR, Kirkham JJ; Reporting Bias Group. Systematic review of the empirical evidence of study publication bias and outcome reporting bias-an updated review. PLoS One. 2013;8(7):e66844.
11. Pich J, Carné X, Arnaiz JA, Gómez B, Trilla A, Rodés J. Role of a research ethics committee in follow-up and publication of results. Lancet. 2003;361(9362):1015-1016. (Pubitemid 36351372)
12. Stern JM, Simes RJ. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ. 1997;315(7109):640-645. (Pubitemid 27387174)
13. Easterbrook PJ, Matthews DR. Fate of research studies. J R Soc Med. 1992;85(2):71-76.
14. Decullier E, Lhéritier V, Chapuis F. Fate of biomedical research protocols and publication bias in France. BMJ. 2005;331(7507):19.
15. Wilson S, Delaney BC, Roalfe A, et al. Randomised controlled trials in primary care: case study. BMJ. 2000;321(7252):24-27. (Pubitemid 30417023)
16. Bower P, Wilson S, Mathers N. Short report: how often do UK primary care trials face recruitment delays? FamPract. 2007;24(6):601-603.
17. Toerien M, Brookes ST, Metcalfe C, et al. A review of reporting of participant recruitment and retention in RCTs in six major journals. Trials. 2009;10:52.
18. Bassler D, BrielM, Montori VM, et al; STOPIT-2 Study Group. Stopping randomized trials early for benefit and estimation of treatment effects. JAMA. 2010;303(12):1180-1187.
19. Kooistra BW, Dijkman BG, Guyatt GH, et al. Prospectively screening for eligible patients was inaccurate in predicting patient recruitment of orthopedic randomized trials. J Clin Epidemiol. 2011;64(5):537-542.
20. Barnard KD, Dent L, Cook A. A systematic review of models to predict recruitment to multicentre clinical trials. BMC Med Res Methodol. 2010;10:63.
21. Treweek S, Pitkethly M, Cook J, et al. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev. 2010;(4):MR000013.
22. Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2(1):e000496.