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Titolo:
Design considerations for efficient prostate cancer chemoprevention trials
Autore:
Lee, JD; Lieberman, R; Sloan, JA; Piantadosi, S; Lippman, SM;
Indirizzi:
Univ Texas, MD Anderson Canc Ctr, Dept Biostat, Houston, TX 77030 USA UnivTexas Houston TX USA 77030 Ctr, Dept Biostat, Houston, TX 77030 USA Univ Texas, MD Anderson Canc Ctr, Dept Clin Can Prevent, Houston, TX 77030USA Univ Texas Houston TX USA 77030 pt Clin Can Prevent, Houston, TX 77030USA Johns Hopkins Oncol Ctr, Baltimore, MD USA Johns Hopkins Oncol Ctr Baltimore MD USA ns Oncol Ctr, Baltimore, MD USA Mayo Clin, Dept Hlth Sci Res, Rochester, MN USA Mayo Clin Rochester MN USA yo Clin, Dept Hlth Sci Res, Rochester, MN USA NCI, Div Canc Prevent, Rockville, MD USA NCI Rockville MD USANCI, Div Canc Prevent, Rockville, MD USA
Titolo Testata:
UROLOGY
fascicolo: 4A, volume: 57, anno: 2001, supplemento:, S
pagine: 205 - 212
SICI:
0090-4295(200104)57:4A<205:DCFEPC>2.0.ZU;2-U
Fonte:
ISI
Lingua:
ENG
Soggetto:
QUALITY-OF-LIFE; SURGICAL-ADJUVANT-BREAST; CLINICAL-TRIALS; PREVENTION TRIAL; BOWEL-PROJECT; BETA-CAROTENE; END-POINTS; HEALTH; MEN; ANTIGEN;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
45
Recensione:
Indirizzi per estratti:
Indirizzo: Lee, JD Univ Texas, MD Anderson Canc Ctr, Dept Biostat, Box 447,1515 Holcombe Blvd, Houston, TX 77030 USA Univ Texas Box 447,1515 Holcombe Blvd Houston TX USA 77030 030 USA
Citazione:
J.D. Lee et al., "Design considerations for efficient prostate cancer chemoprevention trials", UROLOGY, 57(4A), 2001, pp. 205-212

Abstract

Prostate cancer, even with its substantial public health impact of 180,400new cases and 31,900 deaths estimated for 2000, still has a very low annual incidence (0.27% for men 34.4 years and older), which makes designing andconducting efficient prostate cancer prevention trials a challenge. Definitive prevention trials with cancer endpoints, such as the Breast Cancer Prevention Trial (BCPT), Prostate Cancer Prevention Trial (PCPT), and Seleniumand Vitamin E Cancer Prevention Trial (SELECT), require long trial duration (up to 12 years) and large sample size (up to 32,400 subjects) to accomplish their objectives. This article discusses design concepts for potential prostate cancer prevention trials that require fewer years, subjects, and resources to complete. Design elements, such as high-risk populations, randomization, surrogate endpoints, including quality-of-life endpoints, masking/blinding, and various clinical/statistical designs (including 1-way layout, all-versus-none, factorial, and adaptive designs), are discussed, along with the ultimate goal of gaining US Food and Drug Administration approval for prostate-cancer preventive agents that can improve ea public health by reducing prostate cancer incidence and mortality.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 03/04/20 alle ore 11:13:14