Assessing the interpretation of criteria for clinical trial eligibility: A survey of oncology investigators

Clinical and Investigative Medicine

Volumn 21, Issue 1, 1998, Pages 17-26

  Weijer, Charles ^a,b,f   Freedman, Benjamin ^c   Shapiro, Stanley ^d   Fuks, Abraham ^c   Skrutkowska, Myriam ^d   Sigurjonsdottir, Maria ^e  

^a UNIVERSITY OF TORONTO   (Canada)

^b MOUNT SINAI HOSPITAL   (Canada)

^c MCGILL UNIVERSITY   (Canada)

^d MCGILL UNIVERSITY   (Canada)

^e Mount Sinai Hospital ^*

^f MOUNT SINAI HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

AGED; ARTICLE; CANADA; CLINICAL RESEARCH; DECISION MAKING; DEMOGRAPHY; MENTAL DISEASE; METHODOLOGY; PATIENT SELECTION; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

AGE FACTORS; BREAST NEOPLASMS; CANADA; DEMOGRAPHY; ELIGIBILITY DETERMINATION; MEDICAL ONCOLOGY; NATIONAL INSTITUTES OF HEALTH (U.S.); PATIENT SELECTION; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS; SUBSTANCE-RELATED DISORDERS; UNITED STATES;

EID: 0031931405     PISSN: 0147958X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (27)

1. Friedman MA, Cain DF. National Cancer Institute sponsored comparative clinical trials. J Natl Cancer Inst 1990;65:2376-82.
2. Tate HC, Rawlinson JB. Randomized comparative studies in the treatment of cancer in the United Kingdom: room for improvement? Lancet 1979;2:623-5.
3. Begg CB, Zelen M, Carbone PP, McFadden ET, Brodorsky H, Engstrom P, et al. Cooperative groups and community hospitals: measurement of impact in the community hospitals. Cancer 1983; 52: 1760-7.
4. Gotay CC. Accrual to cancer clinical trials: directions from the research literature. Soc Sd Med 1991;33:569-77.
5. Kotwall CA, Mahoney LJ, Myers RE, Decoste L. Reasons for nonentry in randomized clinical trials for breast cancer: a single institution study. J Surg Oncol 1992;50: 125-9.
6. Lee JY, Breaux SR. Accrual of radiotherapy patients to clinical trials. Cancer 1983;52:1014-6.
7. McCusker J, Wax A, Bennett JM. Cancer patient accession into clinical trials: a pilot investigation into some patient and physician determinants of entry. Am J Clin Oncol 1982;5:227-36.
8. Dresser R. Wanted: single, white male for medical research. Hastings Cent Rep 1992;22(1):24-9.
9. Mastroianni AC, Faden R, Federman D. Women and health research. Ethical and legal issues of including women in clinical studies. Vol. 1. Washington: National Academy Press; 1994. p. 75-83.
10. National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Fed Regist 1994;59:4508-13.
11. Begg C, Carbone P. Clinical trials and drug toxicity in the elderly: the experience of the Eastern Cooperative Oncology Group. Cancer 1983;52;1986-92.
12. Fuks A, Weijer C, Freedman B, Shapiro S, Skrutkowska M, Riaz A. A study in contrasts: eligibility criteria in a twenty-year sample of NSABP and POG clinical trials. J Clin Epidemiol. In press.
13. Kennedy BJ. Needed: clinical trials for older patients. J Clin Oncol 1991;9:718-20.
14. Mor V, Masterson-Allen S, Goldberg RJ, Cummings FJ, Glicksman AS, Fretwell MD. Relationship between age at diagnosis and treatments received by cancer patients. J Am Geriatr Soc 1985;33:585-9.
15. Samet J, Hunt WC, Key C, Humble CG, Goodwin JS. Choice of cancer therapy varies with age of patient. JAMA 1986;255:3385-90.
16. Michels R, Marzuk PM. Progress in psychiatry (parts 1 and 2). N Engl J Med 1994;329:552-60,628-38.
17. Hughes JR. Exclusion of "non-compliant" individuals from clinical trials. Controlled Clin Trials 1993;14:176-7.
18. Aitken RCB. Measurement of feelings using visual analogue scales. Proc R Soc Med 1969;62:989-93.
19. Folstein MF, Luria R. Reliability, validity and clinical application of the visual analogue mood scale. Psychol Med 1973;3:479-86.
20. Hunninghake DB, Darby CA, Probstfield JL. Recruitment experience in clinical trials: literature summary and annotated bibliography. Controlled Clin Trials 1987;8: 6S-30S.
21. Taylor KM, Margolese RG, Soskolne C. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med 1984;310:1363-7.
22. MacKillop WJ, Palmer MJ, O'Sullivan B, Quirt CF. The expert surrogate system. In: Williams CJ, editor. Introducing new treatments for cancer: practical, ethical and legal problems. New York: John Wiley and Sons, 1992. p. 459-77.
23. Weijer C, Fuks A. The duty to exclude: excluding people at undue risk from research. Clin Invest Med 1993;17: 115-22.
24. Peto R, Pike MC, Armitage P, Breslow ME, Cox DR, Howard SV, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976;34: 585-612.
25. Stenning S. "The uncertainty principle": selection of patients for cancer clinical trials, in: Williams CJ, editor. Introducing new treatments for cancer: practical, ethical and legal problems. New York: John Wiley and Sons, 1992. p. 161-72.
26. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5.
27. Freedman B. Multi-center trials and subject eligibility: should local IRBs play a role? IRB: Rev Hum Subjects Res 1994; 6(1-2):1-6.