The efficiency of clinical trial designs for predictive biomarker validation

Clinical Trials

Volumn 7, Issue 5, 2010, Pages 557-566

  Young, K Y ^a   Laird, A ^a   Zhou, X H ^a,b  

^a UNIVERSITY OF WASHINGTON   (United States)

^b VA PUGET SOUND HEALTH CARE SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

BIOASSAY; CLINICAL STUDY; CONFERENCE PAPER; EVALUATION; FEASIBILITY STUDY; PREDICTIVE VALIDITY; PREVALENCE; PRIORITY JOURNAL; PRODUCTIVITY; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY; SIMULATION; VALIDATION PROCESS;

BIOLOGICAL MARKERS; HUMANS; PREDICTIVE VALUE OF TESTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 78649943187     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774510370497     Document Type: Conference Paper

References (12)

1. Fine BM, Amler L. Predictive biomarkers in the development of oncology drugs: a therapeutic industry perspective. Clin Pharmacol Therop 2009 ; 85: 535-8.
2. Hammond M., Taube S. Issues and barriers to development of clinically useful tumor markers: a development pathway proposal. Sem Oncol 2002 ; 29: 213-21.
3. Maitournam A., Simon R. On the efficiency of targeted clinical trials. Stat Med 2005 ; 24: 329-39.
4. Lenehan P., Gliklich R., Worzel B., Freshley J. Rescuing drugs through personalized medicine: a new clinical trial design paradigm could potentially transform a failed drug into a successful one. Appl Clin Trials, 2005. Available at: http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/ article/articleDetail.jsp?id=154236&sk=&date=&pageID=4
5. Slamon D., Leyland-Jones B., Shak S., et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpressed HER2. N Engl J Med 2001 ; 344: 783-92.
6. Mandrekar SJ, Grothey A., Goetz MP, Sargent DJ Clinical trial designs for prospective validation of biomarkers. Am J Pharmacogenomics 2005 ; 5: 317-25.
7. Park S., Shimizu C., Shimoyama T. Gene expression profiling of ATP-binding cassette (ABC) transporters as a predictor of the pathologic response to neoadjuvant chemotherapy in breast cancer patients. Breast Cancer Res Treat 2006 ; 99: 9-17.
8. Sargent DJ, Conley BA, Allegra C., Collette L. Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol 2005 ; 23: 2020-7.
9. Wang SJ Biomarker as a classifier in pharmacogenomics clinical trials: a tribute to 30th anniversary of PSI. Pharm Stat 2007 ; 6: 283-96.
10. Wang SJ, O'Neil RT, Hung HMJ. Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset. Pharm Stat 2007 ; 9: 227-44.
11. Lehmann EL, D'Abrera HJM. Nonparametrics: Statistical Methods Based on Ranks. Holden-Day, Inc., San Francisco, 1975.
12. Wagner PD, Verma M., Srivastava S. Challenges for biomarkers in cancer detection. Ann NY Acad Sci 2004 ; 1022: 9-16.