Should women take part in clinical trials in breast cancer? Issues and some solutions

Journal of Clinical Oncology

Volumn 16, Issue 1, 1998, Pages 354-362

  Cockburn, Jill ^a   Redman, Sally ^b   Kricker, Anne ^b  

^a UNIVERSITY OF NEWCASTLE   (Australia)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

BREAST CARCINOMA; CANCER RESEARCH; CLINICAL RESEARCH; COMPETENCE; FEMALE; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; PATIENT COUNSELING; PRIORITY JOURNAL; REVIEW;

EID: 0031973077     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1998.16.1.354     Document Type: Review

References (59)

1. Hill DJ, White VM, Giles GG, et al: Changes in the investigation and management of primary operable breast cancer. Med J Aust 161:110-114, 118, 121-122, 1994
2. Maslin A: A survey of the opinions on "informed consent" of women currently involved in clinical trials within a breast unit. Eur J Cancer Care (Engl) 3:153-162, 1994
3. Simes RJ, Tattersall MH, Coates AS, et al: Randomised comparison of procedures for obtaining consent in clinical trials of treatment for cancer. BMJ 293:1065-1068, 1986
4. Aaronson NK, Visser-Pol E, Leenhouts GH, et al: Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol 14:984-996, 1996
5. Daugherty C, Ratain MJ, Grochowski E, et al: Perceptions of cancer patients and their physicians involved in phase 1 trials. J Clin Oncol 13:1062-1072, 1995
6. Lynoe N, Sandlund M, Dahlqvist G, et al: Informed consent: Study of quality of information given to participants in a clinical trial. BMJ 303:610-613, 1991
7. Jensen AB, Madsen B, Andersen P, et al: Information for cancer patients entering a clinical trial - An evaluation of an information strategy. Eur J Cancer 29A:2235-2238, 1993
8. Olver IN, Buchanan L, Laidlaw C, et al: The adequacy of consent forms for informing patients entering oncological clinical trials. Ann Oncol 6:867-870, 1995
9. Taylor KM, Feldstein ML, Skeel RT, et al: Fundamental dilemmas of the randomized clinical trial process: Results of a survey of the 1737 Eastern Cooperative Oncology Group investigators. J Clin Oncol 12:1796-1805, 1994
10. Williams CJ, Zwitter M: Informed consent in European multicentre randomised clinical trials - Are patients really informed? Eur J Cancer 30A:907-910, 1994
11. Taylor KM, Keiner M: Informed consent: The physicians' perspective. Soc Sci Med 24:135-143, 1987
12. Benson AB, Pregler JP, Bean JA, et al: Oncologists' reluctance to accrue patients onto clinical trials: An Illinois Cancer Center study. J Clin Oncol 9:2067-2075, 1991
13. Llewellyn-Thomas HA, McGreal MJ, Thiel EC, et al: Patients' willingness to enter clinical trials: Measuring the association with perceived benefit and preference for decision participation. Soc Sci Med 32:35-42, 1991
14. Llewellyn-Thomas HA, Thiel EC, Sero FW, et al: Presenting clinical trial information: A comparison of methods. Patient Educ Couns 25:97-107, 1995
15. Gallo C, Pertone F, De Placido S, et al: Informed versus randomised consent to clinical trials. Lancet 346:1060-1064, 1995
16. Ruckdeschel JC, Albrecht TL, Blanchard C, et al: Communication, accrual to clinical trials, and the physician-patient relationship: Implications for training programs. J Cancer Educ 11:73-79, 1996
17. Tomamichel M, Sessa C, Herzig S, et al: Informed consent for phase I studies: Evaluation of quantity and quality of information provided to patients. Ann Oncol 6:363-369, 1994
18. Murphy J, Gamble G, Sharpe N: Readability of subject information leaflets for medical research. N Z Med J 107:509-510, 1994
19. Grossman SA, Piantadosi S, Covahey C: Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 12:221-225, 1994
20. Meade CD, Howser DM: Consent forms: How to determine and improve their readability. Oncol Nurs Forum 19:1523-1528, 1992
21. Simes RJ: Risk benefit relationships in cancer clinical trials; The ECOG experience in nonsmall-cell lung Cancer. J Clin Oncol 3:462-472, 1985
22. Thornton HM: Breast cancer trials: A patient's viewpoint. Lancet 339:44-54, 1992
23. Thornton H: UKDCIS trial - Time for review? Eur J Cancer 29A:428-429, 1993 (comment)
24. Thornton H: Clinical trials - A brave new partnership? J Med Ethics 20:19-22, 1994
25. Smith T: Information for patients. BMJ 305:1242, 1992 (editorial; comment)
26. Schain WS: Barriers to clinical trials. Part II: Knowledge and attitudes of potential participants. Cancer 74:2666-2671, 1994 (suppl 9, review)
27. Lawrence W Jr, Bear HD: Is there really an ethical conflict in clinical trials? Cancer 75:2407-2409, 1995 (comment)
28. Mueller CB: Breast cancer trials on trial. A case of conflicting ethical interests. Cancer 75:2403-2406, 1995
29. Tobias JS, Souhami RL: Fully informed consent can be needlessly cruel. BMJ 307:1199-1201, 1993
30. Baum M: New approach for recruitment into randomised controlled trials. Lancet 341:812-813, 1993
31. Hellman S, Hellman DS: Of mice but not men. Problems of the randomized clinical trial. N Engl J Med 324:1585-1589, 1991
32. Fentiman IS, Joslin CA: The defence for the UKDCIS trial. Eur J Cancer 29A:430, 1993
33. Chalmers I: What do I want from health research and researchers when I am a patient? BMJ 310:1315-1318, 1995
34. Joseph RR: Viewpoints and concerns of a clinical trial participant. Cancer 74:2692-2693, 1994 (suppl 9)
35. Silverman WA: The myth of informed consent: In daily practice and in clinical trials. J Med Ethics 15:6-11, 1989
36. Lawrence W Jr, Antman K, Freeman HP, et al: The impact of clinical trial protocols on patient care systems. Cancer 72:2839-2841, 1993 (suppl 9)
37. Levine RJ: Ethics of clinical trials. Do they help the patient? Cancer 72:2805-2810, 1993 (suppl 9)
38. Middle C, Johnson A, Petty T, et al: Ethics approval for a national postal survey: A recent experience. BMJ 311:659-660, 1995
39. Taylor KM, Shapiro M, Soskolne CL, et al: Physician response to informed consent regulations for randomized clinical trials. Cancer 60:1415-1422, 1987
40. Street RL, Voigt B, Geyer C, et al: Increasing patient involvement in choosing treatment for early breast cancer. Cancer 76: 2275-2285, 1995
41. Northouse PG, Northouse LL: Communication and cancer: Issues confronting patients; health professionals and family members. J Psychosoc Oncol 5:17-46, 1988
42. Milburn M: Being in control: A study of a patient who enters a clinical trial for women with high risk breast cancer. J Cancer Care 5:101-106, 1996
43. Cassidy J, Macfarlane DK: The role of the nurse in clinical cancer research. Cancer Nurs 14:124-131, 1991
44. Grady C: Ethical issues in clinical trials. Semin Oncol Nurs 7:288-296, 1991
45. Meili L: The community hospital perspective of clinical trials and the role of the nurse educator. Semin Oncol Nurs 7:280-287, 1991
46. Engelking C: Facilitating clinical trials - The expanding role of the nurse. Cancer 67:1793-1797, 1991 (suppl 6)
47. Melink TJ, Whitacre MY: Planning and implementing clinical trials. Semin Oncol Nurs 7:243-251, 1991
48. Wong JG: Informed consent in clinical trials. Open discussion promotes trust. BMJ 307:1495, 1993 (letter; comment)
49. Passamani E: Clinical trials-are they ethical? N Engl J Med 324:1589-1592, 1991
50. Maguire P, Fairbairn S, Fletcher C: Consultation skills of young doctors: I - Benefits of feedback training in interviewing as students persist. BMJ 292:1573-1576, 1986
51. Cowan DH, Laidlaw JC: A strategy to improve communication between health care professionals and people living with cancer. 1. Improvement of teaching and assessment of doctor-patient communication in Canadian medical schools. J Cancer Educ 8:109-117, 1993
52. Sanson-Fisher R, Cockburn J: Effective teaching of communication skills: Selecting an appropriate clinical context. Med Educ 31:52-57, 1997
53. Martin HN, Tattersall MHN, Simes RJ: Issues in informed consent, in Williams CJ (ed): Introducing New Treatments for Cancer: Practical, Ethical, and Legal Problems. Chichester, NY, Wiley, 1992, pp 79-80
54. Lawrence W Jr: Patient selection for clinical trials. Risks versus benefits and quality of life issues. Cancer 72:2798-2800, 1993 (suppl 9)
55. Bruera E, Spachynski K, MacEachern T, et al: Cognitive failure in cancer patients in clinical trials. Lancet 341:247-248, 1993 (letter)
56. Tankanow RM, Sweet BV, Weiskopf JA: Patients' perceived understanding of informed consent in investigational drug studies. Am J Hosp Pharm 49:633-635, 1992
57. Kanis JA, Bergmann JF: Informed consent in clinical trials. Full consent may bias outcome of trials. BMJ 307:1497, 1993
58. Thornton H: A "ladyplan" for trial recruitment? Everyone's business. Lancet 341:795-796, 1993 (comment)
59. Goodare H, Smith R: The rights of patients in research. BMJ 310:1277-1278, 1995 (editorial, comment)