Patients in phase I trials of anti-cancer agents in Japan: Motivation, comprehension and expectations

British Journal of Cancer

Volumn 76, Issue 1, 1997, Pages 107-113

  Itoh, K ^a   Sasaki, Y ^a   Fujii, H ^a   Ohtsu, T ^a   Wakita, H ^a   Igarashi, T ^a   Abe, K ^a  

^a NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

Author keywords

Patients' feelings; Phase I trials; Questionnaire

Indexed keywords

6 FORMYLAMINO 12,13 DIHYDRO 1,11 DIHYDROXY 5H INDOLO[2,3 A][PYRROLO[3,4 C]CARBAZOLE 5,7(6H) DIONE 13 GLUCOSIDE; ANTINEOPLASTIC AGENT; DOXORUBICIN; IM 216; UNCLASSIFIED DRUG; VALSPODAR;

ADVERSE DRUG REACTION; ARTICLE; CANCER; CANCER CENTER; CANCER CHEMOTHERAPY; CANCER PATIENT; CLINICAL ARTICLE; CLINICAL TRIAL; EXPECTATION; HUMAN; MOTIVATION; PATIENT INFORMATION; PATIENT SATISFACTION; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; QUESTIONNAIRE;

EID: 0030950354     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/bjc.1997.344     Document Type: Article

References (21)

1. Cassileth BR, Zupkis RV, Sutton-Smith K and March V (1980) Informed consent - why are its goals imperfectly realized? N Engl J Med 302: 896-900
2. Daugherty C, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R and Siegler M (1995) Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13: 1062-1072
3. Decoster G, Stein G and Holdener EE (1990) Responses and toxic deaths in phase I clinical trials. Ann Oncol 1: 175-181
4. Emanuel EJ (1995) A phase I trial on the ethics of phase I trials. J Clin Oncol 13: 1049-1051
5. Estey E, Hoth D, Simon R, Marsoni S, Leyland-Jones B and Wittes R (1986) Therapeutic response in phase I trials of antineoplastic agents. Cancer Treat Rep 70: 1105-1115
6. Fukaura A, Tazawa H, Nakajima H and Adachi M (1995) Do-not-resuscitate orders at a teaching hospital in Japan. New Engl J Med 333: 805-808
7. Itoh K, Sasaki Y, Miyata Y, Fujii H, Ohtsu T, Wakita H, Igarashi T and Abe K (1994) Therapeutic response and potential pitfalls in phase I trials of anticancer agents conducted in Japan. Cancer Chemother Pharmacol 34: 451-454
8. Kodish E, Stocking C, Ratain MJ, Kohrman A and Siegler M (1992) Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons. J Clin Oncol 10: 1810-1816
9. Lavelle-Jones C, Byrne DJ, Rice P and Cuschieri A (1993) Factors affecting quality of informed consent. BMJ 306: 885-890
10. Lipsett MB (1982) On the nature and ethics of phase I clinical trials of cancer chemotherapies. JAMA 248: 941-942
11. Mick R, Lane N, Daugherty C and Ratain MJ (1994) Physician-determined patient risk of toxic effects: impact on enrollment and decision making in phase I cancer trials. J Natl Cancer Inst 86: 1685-1693
12. Penman DT, Holland JC, Bahna GF, Morrow G, Schmale AH, Derogatis LR, Carnrike CL and Cherry R (1984) Informed consent for investigational chemotherapy: patients' and physicians' perceptions. J Clin Oncol 2: 849-855
13. Penta JS, Rosner GL and Trump DL (1992) Choice of starting dose and escalation for phase I studies of antitumor agents. Cancer Chemother Pharmacol 31: 247-250
14. Ratain MJ, Mick R, Schilsky RL and Siegler M (1993) Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents. J Natl Cancer Inst 85: 1637-1643
15. Rodenhuis S, Van Den Heuvel WJA, Annyas AA, Koops HS, Sleijfer DT and Mulder NH (1984) Patient motivation and informed consent in a phase I study of an anticancer agent. Eur J Cancer Clin Oncol 20: 457-462
16. Simon R (1993) Design and conduct of clinical trials. In Cancer: Principle and Practice of Oncology, DeVita VT, Hellman S and Rosenberg SA. (eds), pp. 418-440. J B Lippencott: Philadelphia
17. Suemasu K, Abe K, Kawana S, Kurihara M, Saijoh N, Sakuma A, Shimoyama M, Tsukagoshi S and Nakajima S (1991) The Japanese guidelines for the methodology of clinical evaluation of anti-neoplastic drugs. In Anti-neoplastic Drugs: Guidelines for Clinical Evaluation (in Japanese), Nihon-Kouseibussitu-Gakujutukyougikai. (ed.), pp. 49-74. Mikusu: Tokyo
18. Tobias JS and Houghton J (1994) Is informed consent essential for all chemotherapy studies? Eur J Cancer, 30A: 897-899
19. Tomamichel M, Sessa C, Herzig S, Jong Jd, Pagani O, Willems Y and Cavalli F (1995) Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients. Ann Oncol 6: 363-369
20. Von Hoff DD and Turner J (1991) Response rates, duration of response, and dose response effects in phase I studies of antineoplastics. Invest New Drugs 9: 115-122
21. Willems Y and Sessa C (1989) Informing patients about phase I trials - how should it be done? Acta Oncol 28: 106-107