Subgroups

Methods and Applications of Statistics in Clinical Trials

Volumn 1, Issue , 2014, Pages 850-866

  Wittes, Janet ^a  

^a University of Iowa   (United States)

Author keywords

Clinical trials; Patient subsets; Patient specific variables; Subgroup specific effects

Indexed keywords

CLINICAL TRIAL; ITS DATA; PATIENT SPECIFIC; SPECIFIC EFFECTS; TREATMENT EFFECTS;

PATIENT TREATMENT;

EID: 84963770231     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118596005.ch72     Document Type: Chapter

References (21)

1. CABG Surgery Pooling Group, Metaanalysis of coronary bypass surgery trials. 1994.
2. A. Oxman and G. Guyatt, A consumer's guide to subgroup analysis. Annu. Intern. Med. 1992; 116: 78-84.
3. A. Donner, A Bayesian approach to the interpretation of subgroup results in clinical trials. J. Chronic Dis. 1982; 35: 429- 435.
4. R. Simon, Patient subsets and variation in therapeutic efficacy. Br. J. Clin. Pharmacol 1982; 14: 473-482.
5. S. Yusuf, J. Wittes, J. Probstfield, et al., Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266: 93-98.
6. C. E. Davis and D. Leffinwell, Empirical Bayes estimates of subgroup effects in clinical trials. Control Clin Trials 1990; 11: 347-353.
7. R. Peto, Clinical trial methodology. Biomedicine 1978; 28: 24-36.
8. M. Gail and R. Simon, Testing for qualitative interactions between treatment effects and patient subsets. Biometrics 1985; 41: 361-372.
9. S. Yusuf, J. Wittes, and L. Friedman, Overview of results of randomized clinical trials in heart disease. I. Treatments following myocardial infarction. JAMA 1988; 260: 2088-2093.
10. S. Yusuf, J. Wittes, and L. Friedman, Overview of results of randomized clinical trials in heart disease. II. Unstable angina, heart failure, primary prevention with aspirin, and risk factor modification. JAMA 1988; 260: 2259-2263.
11. J. Anderson, J. Wilson, D. Jenkin, et al., Childhood non-Hodgkin's lymphoma. The results of a randomized therapeutic trial comparing a 4-drug regimen (COMP) with a 10-drug regimen (LSA2- L2). N. Engl J. Med. 1983; 308: 559- 565.
12. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group, Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17 187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 2: (8607); 1988; 349-360.
13. J. Hamilton, P. Hartigan, M. Simberkoff, et al., A controlled trial of early versus late treatment with zidovudine in symptomatic human immunodeficiency virus infection. Results of the Veterans Affairs Cooperative Study (see comments). N. Engl. J. Med. 1992; 326: 437-443.
14. Steering Committee of the Physicians' Health Study Research Group, Final report on the aspirin component of the ongoing Physicians' Health Study. N Engl J Med. 1989; 321: 129-135.
15. C. Furberg and R. Byington, What do subgroup analyses reveal about differential response to beta-blocker therapy? The Beta-Blocker Heart Attack Trial experience. Circulation 1983; 67: 98-101.
16. N. N. Taleb, Fooled by Randomness: The Hidden Role of Chance in Life and in the Markets. New York: Thomson/Texere, 2004.
17. The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group, Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension. J. Clin. Epidemiol. 1988; 41: 1197-1208.
18. D. Wendler, R. Kington, J. Madans, et al., Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine 2006; 3: 0201-0209.
19. S. Assmann, S. Pocock, L. Enos, et al., Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000; 355: 1064-1069.
20. R. L. Greenman, R. M. H. Schein, and M. A. Martin, A controlled clinical trial of E5 murine monoclonal IgM antibody to endotoxin in the treatment of Gramnegative sepsis. JAMA 1991; 266: 1097- 1102.
21. E. Ziegler, C. Fisher, C. Sprung, et al., Treatment of gram-negative bacteremia and septic shock with HA-1A human monoclonal anitbody against endotoxin. N. Engl. J. Med. 1991; 324: 429-436.