Reporting of analyses from randomized controlled trials with multiple arms: A systematic review

BMC Medicine

Volumn 11, Issue 1, 2013, Pages

  Baron, Gabriel ^a,b,c   Perrodeau, Elodie ^a,b,c   Boutron, Isabelle ^a,b,c,d   Ravaud, Philippe ^a,b,c,d,e  

^a INSERM   (France)

^b HÔTEL DIEU   (France)

^c UNIVERSITÉ PARIS DESCARTES   (France)

^d ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^e Department of Medicine   (United States)

Author keywords

Multiple arms; Randomized controlled trials; Reporting of analyses; Systematic review

Indexed keywords

ARTICLE; BIBLIOGRAPHIC DATABASE; CALCULATION; COMPARATIVE STUDY; DATA EXTRACTION; HUMAN; MEDICAL LITERATURE; MEDLINE; MULTIPLE ARM RANDOMIZED TRIAL; OUTCOME ASSESSMENT; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STANDARDIZATION; SYSTEMATIC REVIEW (TOPIC);

BIOMEDICAL RESEARCH; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84875302738     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/1741-7015-11-84     Document Type: Article

References (23)

1. Cook RJ, Farewell VT. Multiplicity considerations in the design and analysis of clinical trials. J R Statistic Soc A 1996, 159(1):93-110.
2. Committee for Proprietary Medicinal Products Points to consider on multiplicity issued in clinical trials http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf, Committee for Proprietary Medicinal Products.
3. Freidlin B, Korn EL, Gray R, Martin A. Multi-arm clinical trials of new agents: some design considerations. Clin Cancer Res 2008, 14(14):4368-4371. 10.1158/1078-0432.CCR-08-0325, 18628449.
4. Jung SH, George SL. Between-arm comparisons in randomized Phase II trials. J Biopharm Stat 2009, 19(3):456-468. 10.1080/10543400902802391, 2673021, 19384688.
5. Proschan MA. A multiple comparison procedure for three- and four-armed controlled clinical trials. Stat Med 1999, 18(7):787-798. 10.1002/(SICI)1097-0258(19990415)18:7<787::AID-SIM77>3.0.CO;2-M, 10327527.
6. Schulz KF, Grimes DA. Multiplicity in randomised trials I: endpoints and treatments. Lancet 2005, 365(9470):1591-1595. 10.1016/S0140-6736(05)66461-6, 15866314.
7. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005, 365(9465):1159-1162. 10.1016/S0140-6736(05)71879-1, 15794971.
8. Committee for Proprietary Medicinal Products Note for guidance on choice of control group in clinical trials http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdf, Committee for Proprietary Medicinal Products.
9. Vermorken JB, Parmar MK, Brady MF, Eisenhauer EA, Hogberg T, Ozols RF, Rochon J, Rustin GJ, Sagae S, Verheijen RH. Clinical trials in ovarian carcinoma: study methodology. Ann Oncol 2005, 16(Suppl 8):viii20-viii29.
10. Schulz KF, Grimes DA. Multiplicity in randomised trials II: subgroup and interim analyses. Lancet 2005, 365(9471):1657-1661. 10.1016/S0140-6736(05)66516-6, 15885299.
11. Cochrane Handbook for Systematic Reviews of Interventions 2008, Chichester: Wiley, Higgins JPT, Green S.
12. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004, 291(20):2457-2465. 10.1001/jama.291.20.2457, 15161896.
13. Juszczak E, Altman D, Chan AW. A review of the methodology and reporting of multi-arm, parallel group, randomised clinical trials (RCTs). 3rd Joint Meeting of the International Society for Clinical Biostatistics and Society for Clinical Trials 2003, London (UK).
14. Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA 1994, 272(2):122-124. 10.1001/jama.1994.03520020048013, 8015121.
15. Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P. Reporting of sample size calculation in randomised controlled trials: review. BMJ 2009, 338:b1732. 10.1136/bmj.b1732, 2680945, 19435763.
16. Boissel JP. How to deal with multiple treatment or dose groups in randomized clinical trials? Another approach. Fundam Clin Pharmacol 2007, 21(2):155-156. 10.1111/j.1472-8206.2007.00478.x, 17391287.
17. Hothorn LA. How to deal with multiple treatment or dose groups in randomized clinical trials?. Fundam Clin Pharmacol 2007, 21(2):137-154. 10.1111/j.1472-8206.2007.00469.x, 17391286.
18. Proschan MA, Waclawiw MA. Practical guidelines for multiplicity adjustment in clinical trials. Control Clin Trials 2000, 21(6):527-539. 10.1016/S0197-2456(00)00106-9, 11146147.
19. Chan AW, Upshur R, Singh JA, Ghersi D, Chapuis F, Altman DG. Research protocols: waiving confidentiality for the greater good. BMJ 2006, 332(7549):1086-1089. 10.1136/bmj.332.7549.1086, 1458595, 16675819.
20. Hill CL, LaValley MP, Felson DT. Discrepancy between published report and actual conduct of randomized clinical trials. J Clin Epidemiol 2002, 55(8):783-786. 10.1016/S0895-4356(02)00440-7, 12384192.
21. Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swann S, Djulbegovic B. Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group. BMJ 2004, 328(7430):22-24. 10.1136/bmj.328.7430.22, 313900, 14703540.
22. Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004, 328(7441):702-708. 10.1136/bmj.328.7441.702, 381234, 15031246.
23. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c869. 10.1136/bmj.c869, 2844943, 20332511.