Do investigators show selection biases when enrolling patients in phase I oncology registration trials?

Journal of Geriatric Oncology

Volumn 2, Issue 1, 2011, Pages 25-30

  Yonemori, Kan ^a   Hirakawa, Akihiro ^b   Ando, Masashi ^a   Hirata, Taizo ^a   Shimizu, Chikako ^a   Katsumata, Noriyuki ^a   Tamura, Kenji ^a   Fujiwara, Yasuhiro ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b TOKYO UNIVERSITY OF SCIENCE   (Japan)

Author keywords

Age; Barrier; Elderly patients; Oncology; Performance status; Phase I; Registration trial

Indexed keywords

CYTOTOXIC AGENT;

ADULT; AGE DISTRIBUTION; AGED; AGING; ARTICLE; CANCER PATIENT; CANCER REGISTRY; CANCER RESEARCH; CONTROLLED STUDY; DEMOGRAPHY; DESCRIPTIVE RESEARCH; DRUG RESEARCH; FEMALE; GEOGRAPHIC DISTRIBUTION; HUMAN; JAPAN; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASTIC DISEASE; PATIENT PARTICIPATION; PERFORMANCE; PERFORMANCE STATUS; PHASE 1 CLINICAL TRIAL; POPULATION RESEARCH; SEX RATIO; UNITED STATES;

EID: 78650419771     PISSN: 18794068     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jgo.2010.09.003     Document Type: Article

References (25)

1. Horstmann E., McCabe M.S., Grochow L., Yamamoto S., Rubinstein L., Budd T., et al. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 2005, 352:895-904.
2. Decoster G., Stein G., Holdener E.E. Responses and toxic deaths in phase I clinical trials. Ann Oncol 1990, 1:175-181.
3. Estey E., Hoth D., Simon R., Marsoni S., Leyland-Jones B., Wittes R. Therapeutic response in phase I trials of antineoplastic agents. Cancer Treat Rep 1986, 70:1105-1115.
4. Bachelot T., Ray-Coquard I., Catimel G., Ardiet C., Guastalla J.P., Dumortier A., et al. Multivariable analysis of prognostic factors for toxicity and survival for patients enrolled in phase I clinical trials. Ann Oncol 2000, 11:151-156.
5. Han C., Braybrooke J.P., Deplanque G., Taylor M., Mackintosh D., Kaur K., et al. Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs. new noncytotoxic agents. Br J Cancer 2003, 89:1166-1171.
6. Roberts T.G., Goulart B.H., Squitieri L., Stallings S.C., Halpern E.F., Chabner B.A., et al. Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 2004, 292:2130-2140.
7. Arkenau H.T., Olmos D., Ang J.E., de Bono J., Judson I., Kaye S. Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the Royal Marsden Hospital experience. Br J Cancer 2008, 98:1029-1033.
8. Pharmaceutical research and development. Data book 2010, 37-55. Japan pharmaceutical manufactures association, Japan Pharmaceutical Manufacture Association, Tokyo.
9. Farrell A.T., Papadouli I., Hori A., Harczy M., Harrison B., Asakura W., et al. The advisory process for anticancer drug regulation: a global perspective. Ann Oncol 2006, 17:889-896.
10. Pharmaceuticals and Medical Devices Agency: Public assessment report. (last accessed on 1 March 2010). http://www.info.pmda.go.jp/shinyaku/shinyaku_index.html.
11. Japan Pharmacists Education Center: Public assessment report. (last accessed on 20 October 2009). http://www.jpec.or.jp/contents/c01/link.html.
12. Nomura K. Cancer Statistics in Japan 2003 2003, Foundation for Promotion Cancer Research, Tokyo.
13. Annual Report on Health. Labour and Welfare 2003-2004 2004, Ministry of Health Labor and Welfare, Gyosei, Tokyo.
14. Surveillance, Epidemiology, and End Results: (last accessed on 1 March 2010). http://www.seer.cancer.gov.
15. Janisch L., Mick R., Schilsky R.L., Vogelzang N.J., O'Brien S., Kut M., et al. Prognostic factors for survival in patients treated in phase I clinical trials. Cancer 1994, 74:1965-1973.
16. Seidenfeld J., Horstmann E., Emanuel E.J., Grady C. Participants in phase 1 oncology research trials: are they vulnerable?. Arch Intern Med 2008, 168:16-20.
17. Penel N., Vanseymortier M., Bonneterre M.E., Clisant S., Dansin E., Vendel Y., et al. Prognostic factors among cancer patients with good performance status screened for phase I trials. Invest New Drugs. 2008, 26:53-58.
18. Greenlee R.T., Murray T., Bolden S., Wingo P.A. Cancer statistics. CA Cancer J Clin 2000, 50:7-33.
19. Ford J.G., Howerton M.W., Lai G.Y., Gary T.L., Bolen S., Gibbons M.C., et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 2008, 112:228-242.
20. Townsley C.A., Selby R., Siu L.L. Systemic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol 2005, 23:3112-3124.
21. Talarico L., Chen G., Pazdur R. Enrollment of elderly patients in clinical trial for cancer drug registration: a 7-year experience by the US Food and Drug Administration. J Clin Oncol 2004, 22:4626-4631.
22. Shipp M.A., Harrington D.P., Klatt M.M., Jochelson M.S., Pinkus G.S., Marshall J.L., et al. Identification of major prognostic subgroups of patients with large-cell lymphoma treated with m-BACOD or M-BACOD. Ann Intern Med 1986, 104:757-765.
23. Tam C.S., Wolf M.M., Januszewicz E.H., Grigg A.P., Prince H.M., Westerman D., et al. A new model for predicting infectious complications during fludarabine-based combination chemotherapy among patients with indolent lymphoid malignancies. Cancer 2004, 101:2042-2049.
24. Janssen-Heijnen M.L., van Spronsen D.J., Lemmens V.E., Houterman S., Verheij K.D., Coebergh J.W. A population-based study of severity of comorbidity among patients with non-Hodgkin's lymphoma: prognostic impact independent of International Prognostic Index. Br J Haematol 2005, 129:597-606.
25. Cabinet Office Director-general for Policies on Cohesive Society White paper on aging society 2009 2009, Cabinet Office, Tokyo.