Stopping randomized trials early for benefit: A protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

Trials

Volumn 10, Issue , 2009, Pages

  Briel, Matthias ^a,b   Lane, Melanie ^c   Montori, Victor M ^c   Bassler, Dirk ^d   Glasziou, Paul ^e   Malaga, German ^f   Akl, Elie A ^g   Ferreira Gonzalez, Ignacio ^h   Alonso Coello, Pablo ⁱ   Urrutia, Gerard ⁱ   Kunz, Regina ^b   Culebro, Carolina Ruiz ^a   da Silva, Suzana Alves ^j   Flynn, David N ^c   Elamin, Mohamed B ^c   Strahm, Brigitte ^k   Hassan Murad, Mohammad ^c   Djulbegovic, Benjamin ^l   Adhikari, Neill K J ^m   Mills, Edward J ⁿ   Gwadry Sridhar, Femida ^o   Kirpalani, Haresh ^a,p   Soares, Heloisa P ^q   Abu Elnour, Nisrin O ^c   You, John J ^a   Karanicolas, Paul J ^o   Bucher, Heiner C ^b   Lampropulos, Julianna F ^c   Nordmann, Alain J ^b   Burns, Karen E A ^r   Mulla, Sohail M ^a   Raatz, Heike ^b   Sood, Amit ^c   Kaur, Jagdeep ^a   Bankhead, Clare R ^e   Mullan, Rebecca J ^c   Nerenberg, Kara A ^a   Vandvik, Per Olav ^s   Coto Yglesias, Fernando ^t   Schünemann, Holger ^a   Tuche, Fabio ^j   Chrispim, Pedro Paulo M ^u   Cook, Deborah J ^a   Lutz, Kristina ^a   Ribic, Christine M ^a   Vale, Noah ^a   Erwin, Patricia J ^c   Perera, Rafael ^e   Zhou, Qi ^a   Heels Ansdell, Diane ^a   Ramsay, Tim ^v   Walter, Stephen D ^a   Guyatt, Gordon H ^a   more..

^a MCMASTER UNIVERSITY   (Canada)

^b UNIVERSITY HOSPITAL BASEL   (Switzerland)

^c MAYO CLINIC   (United States)

^d UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^e UNIVERSITY OF OXFORD   (United Kingdom)

^f UNIVERSIDAD PERUANA CAYETANO HEREDIA   (Peru)

^g UNIVERSITY AT BUFFALO   (United States)

^h HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

ⁱ HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^j Teaching and Research Center of Pro Cardiaco   (Brazil)

^k UNIVERSITY OF FREIBURG   (Germany)

^l UNIVERSITY OF SOUTH FLORIDA   (United States)

^m UNIVERSITY OF TORONTO   (Canada)

ⁿ UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^o UNIVERSITY OF WESTERN ONTARIO   (Canada)

^p CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^q MOUNT SINAI MEDICAL CENTER   (United States)

^r ST MICHAEL'S HOSPITAL   (Canada)

^s Innlandet Hospital Health Authority   (Norway)

^t Hospital Nacional de Geriatría Y Gerontología   (Costa Rica)

^u INSTITUTO OSWALDO CRUZ   (Brazil)

^v OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BAYES THEOREM; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL STUDY; METHODOLOGY; OBSERVER BIAS; OBSERVER VARIATION; OUTCOMES RESEARCH; QUALITATIVE RESEARCH; QUALITY CONTROL; RANDOM SAMPLE; RESEARCH ETHICS; RISK FACTOR; DECISION MAKING; EPIDEMIOLOGY; EVIDENCE BASED MEDICINE; HUMAN; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL; STATISTICS; TREATMENT OUTCOME;

BAYES THEOREM; BIAS (EPIDEMIOLOGY); CLINICAL TRIALS DATA MONITORING COMMITTEES; DECISION MAKING; EVIDENCE-BASED MEDICINE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 68849092556     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-10-49     Document Type: Article

References (23)

1. Schulz KF Grimes DA Multiplicity in randomised trials II: Subgroup and interim analyses Lancet 2005, 365:1657-1661 10.1016/ S0140-6736(05)66516-6 15885299
2. Pocock S White I Trials stopped early: Too good to be true? Lancet 1999, 353:943-944 10.1016/S0140-6736(98)00379-1 10459899
3. Montori VM Devereaux PJ Adhikari NK Burns KE Eggert CH Briel M Lacchetti C Leung TW Darling E Bryant DM Bucher HC Schunemann HJ Meade MO Cook DJ Erwin PJ Sood A Sood R Lo B Thompson CA Zhou Q Mills E Guyatt GH Randomized trials stopped early for benefit: A systematic review JAMA 2005, 294:2203-2209 10.1001/jama.294.17.2203 16264162
4. Trotta F Apolone G Garattini S Tafuri G Stopping a trial early in oncology: For patients or for industry? Ann Oncol 2008, 19:1347-1353 10.1093/annonc/mdn042 18304961
5. Pocock SJ When (not) to stop a clinical trial for benefit JAMA 2005, 294:2228-2230 10.1001/jama.294.17.2228 16264167
6. Montori VM Wilczynski NL Morgan D Haynes RB Optimal search strategies for retrieving systematic reviews from Medline: Analytical survey BMJ 2005, 330:68 543864 15619601 10.1136/bmj.38336.804167.47
7. Goodman SN Stopping at nothing? Some dilemmas of data monitoring in clinical trials Ann Intern Med 2007, 146:882-887 17577008
8. Goodman SN Systematic reviews are not biased by results from trials stopped early for benefit J Clin Epidemiol 2008, 61:95-96 10.1016/ j.jclinepi.2007.06.012 18083466
9. Bassler D Ferreira-Gonzalez I Briel M Cook DJ Devereaux PJ Heels-Ansdell D Kirpalani H Meade MO Montori VM Rozenberg A Schunemann HJ Guyatt GH Systematic reviewers neglect bias that results from trials stopped early for benefit J Clin Epidemiol 2007, 60:869-873 10.1016/ j.jclinepi.2006.12.006 17689802
10. Norman GR Sloan JA Wyrwich KW Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation Med Care 2003, 41:582-592 10.1097/ 00005650-200305000-00004 12719681
11. Djulbegovic B Lacevic M Cantor A Fields KK Bennett CL Adams JR Kuderer NM Lyman GH The uncertainty principle and industry-sponsored research Lancet 2000, 356:635-638 10.1016/S0140-6736(00)02605-2 10968436
12. Soares HP Kumar A Daniels S Swann S Cantor A Hozo I Clark M Serdarevic F Gwede C Trotti A Djulbegovic B Evaluation of new treatments in radiation oncology: Are they better than standard treatments? JAMA 2005, 293:970-978 1779758 15728168 10.1001/jama.293.8.970
13. Joffe S Harrington DP George SL Emanuel EJ Budzinski LA Weeks JC Satisfaction of the uncertainty principle in cancer clinical trials: retrospective cohort analysis BMJ 2004, 328:1463 428513 15163611 10.1136/ bmj.38118.685289.55
14. Pocock SJ Hughes MD Practical problems in interim analyses, with particular regard to estimation Control Clin Trials 1989, 10:209S-221S 10.1016/0197-2456(89)90059-7 2605969
15. Sydes MR Altman DG Babiker AB Parmar MK Spiegelhalter DJ Reported use of data monitoring committees in the main published reports of randomized controlled trials: A cross-sectional study Clin Trials 2004, 1:48-59 10.1191/1740774504cn003oa 16281462
16. Mueller PS Montori VM Bassler D Koenig BA Guyatt GH Ethical issues in stopping randomized trials early because of apparent benefit Ann Intern Med 2007, 146:878-881 17577007
17. McCartney M Leaping to conclusions BMJ 2008, 336:1213-1214 2405859 18511794 10.1136/bmj.39589.396840.94
18. Hopewell S Clarke M Moher D Wager E Middleton P Altman DG Schulz KF CONSORT for reporting randomized controlled trials in journal and conference abstracts: Explanation and elaboration PLoS Med 2008, 5:e20 2211558 18215107 10.1371/journal.pmed.0050020
19. Moher D Cook DJ Eastwood S Olkin I Rennie D Stroup DF Improving the quality of reports of meta-analyses of randomised controlled trials: The QUOROM statement. Quality of Reporting of Meta-analyses Lancet 1999, 354:1896-1900 10.1016/S0140-6736(99)04149-5 10584742
20. Palda VA Detsky AS Perioperative assessment and management of risk from coronary artery disease Ann Intern Med 1997, 127:313-328 9265434
21. Eagle KA Berger PB Calkins H Chaitman BR Ewy GA Fleischmann KE Fleisher LA Froehlich JB Gusberg RJ Leppo JA Ryan T Schlant RC Winters WL Jr Gibbons RJ Antman EM Alpert JS Faxon DP Fuster V Gregoratos G Jacobs AK Hiratzka LF Russell RO Smith SC Jr ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery - executive summary: A report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (Committee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery) J Am Coll Cardiol 2002, 39:542-553 10.1016/ S0735-1097(01)01788-0 11823097
22. Moher D Schulz KF Altman DG The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials Ann Intern Med 2001, 134:657-662 11304106
23. Guyatt GH Oxman AD Vist GE Kunz R Falck-Ytter Y Alonso-Coello P Schunemann HJ GRADE: An emerging consensus on rating quality of evidence and strength of recommendations BMJ 2008, 336:924-926 2335261 18436948 10.1136/bmj.39489.470347.AD