Composite and surrogate outcomes in randomised controlled trials

British Medical Journal

Volumn 334, Issue 7597, 2007, Pages 756-757

  Freemantle, Nick ^a   Calvert, Mel ^b  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

GLIBENCLAMIDE; METFORMIN; ROSIGLITAZONE;

ANALYTICAL ERROR; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG CONTROL; DRUG INDUSTRY; DRUG INFORMATION; DRUG MARKETING; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HOSPITAL ADMISSION; HUMAN; MORTALITY; NON INSULIN DEPENDENT DIABETES MELLITUS; PHYSICIAN; PRIORITY JOURNAL;

DRUG APPROVAL; ENDPOINT DETERMINATION; EVIDENCE-BASED MEDICINE; RANDOMIZED CONTROLLED TRIALS;

EID: 34247495694     PISSN: 09598146     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmj.39176.461227.80     Document Type: Editorial

References (8)

1. Ferreira-González I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM, et al. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ 2007 doi: 10.1136/bmj.39136.682083.A.
2. Moyé LA. End-point interpretation in clinical trials: the case for discipline. Control Clin Trials 1999;20:40-9.
3. Khan SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006;355:2427-43.
4. Reuters. Glaxo sees new study boosting Avandia, Avandamet. 4 Dec 2006. www.reuters.com/article/idUSL0440072620061204.
5. Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials - greater precision but with greater uncertainty? JAMA 2003;289:2554-9.
6. Montori VM, Permanyer-Miralda G, Ferreira-González I, Busse JW, Pacheco-Huergo V, Bryant D, et al. Validity of composite end points in clinical trials. BMJ 2005;330:594-6.
7. The DREAM (Diabetes Reduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet 2006;368:1096-105.
8. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Statistical principles for clinical trials (ICH E9). 5 Feb 1998. www.ich.org/LOB/media/MEDIA485.pdf.