End points and United States Food and Drug Administration approval of oncology drugs

Journal of Clinical Oncology

Volumn 21, Issue 7, 2003, Pages 1404-1411

  Johnson, John R ^a   Williams, Grant ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; CONTROLLED STUDY; DRUG APPROVAL; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; SYMPTOMATOLOGY; UNITED STATES; BIOASSAY; METHODOLOGY; STANDARD;

ANTINEOPLASTIC AGENTS; DRUG APPROVAL; ENDPOINT DETERMINATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0037986306     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.08.072     Document Type: Article

References (17)

1. Schein PS: The case for a new national program for the development of cancer therapeutics. J Clin Oncol 19:3142-3153, 2001
2. 21 Code of Federal Regulations, Part 314.126
3. 21 Code of Federal Regulations, Part 314.530
4. Johnson JR, Temple R: Food and Drug Administration requirements for approval of anticancer drugs. Cancer Treat Rep 69:1155-1159, 1985
5. O'Shaughnessy J, Wittes R, Burke G, et al: Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials. J Clin Oncol 9:2225-2232, 1991
6. Justice R: FDA role in cancer drug development and requirements for approval, in: Teicher B (ed): Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval. Totowa, NJ, Humana Press, 1997
7. Johnson JR: Transcript of the 66th Meeting of the FDA Oncologic Drugs Advisory Committee, Rockville, MD, December 13, 2000. Http:// www.fda.gov/cder/audiences/acspage/
8. Transcript of the 57th Meeting of the FDA Oncologic Drugs Advisory Committee, Rockville, MD, June 2, 1998. Http://www.fda.gov/cder/audiences /acspage/
9. Johnson JR: A regulatory view, in: Walker SR, Rosser RM (eds): Quality of Life Assessment: Key Issues in the 1990s (ed 2). Boston, MA, Kluwer Academic Publishers, 1992, pp 393-400
10. Miller AB, Hoogstraten B, Staquet M, et al: Reporting results of cancer treatment. Cancer 47:207-214, 1981
11. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216, 2000
12. Fleming T, DeMets D: Surrogate end points in clinical trials: Are we being misled? Ann Intern Med 125:605-613, 1996
13. Buyse M, Thirion P, Carlson RW, et al: Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: A meta-analysis. Lancet 356:373-378, 2000
14. Williams G, Kun He, Chen G, et al: Operational bias in assessing time-to-progression (TTP). Proc Am Soc Clin Oncol 21:244a, 2002 (abstr 975)
15. Transcript of the 68th Meeting of the FDA Oncologic Drugs Advisory Committee, Rockville, MD, September 10, 2001. Http://www.fda.gov/cder/ audiences/acspage/
16. Norton L: A Gompertzian model of human breast cancer growth. Cancer Res 48:7067-7071, 1988
17. Norton L: Kinetic concepts in the systemic drug therapy of breast cancer. Semin Oncol 26:1-20, 1999 (suppl 2)