The direct assignment option as a modular design component: An example for the setting of two predefined subgroups

Computational and Mathematical Methods in Medicine

Volumn 2015, Issue , 2015, Pages

  An, Ming Wen ^a   Lu, Xin ^b   Sargent, Daniel J ^c   Mandrekar, Sumithra J ^c  

^a VASSAR COLLEGE   (United States)

^b EMORY UNIVERSITY   (United States)

^c MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ERROR ANALYSIS; PATIENT TREATMENT;

DESIGN FRAMEWORKS; FLEXIBLE DESIGNS; INTERIM ANALYSIS; MODULAR DESIGNS; RANDOMIZED DESIGN; RESPONSE RATE; STATISTICAL PROPERTIES; TYPE I ERROR RATE;

STATISTICAL METHODS;

ARTICLE; CONTROL GROUP; CONTROLLED STUDY; HUMAN; POST HOC ANALYSIS; RANDOMIZATION; SIMULATION; STUDY DESIGN; COMPUTER SIMULATION; METHODOLOGY; PHASE 2 CLINICAL TRIAL (TOPIC); REPRODUCIBILITY; SAMPLE SIZE; SOFTWARE; STATISTICAL MODEL; STATISTICS;

CLINICAL TRIALS, PHASE II AS TOPIC; COMPUTER SIMULATION; HUMANS; MODELS, STATISTICAL; RANDOM ALLOCATION; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SAMPLE SIZE; SOFTWARE; STATISTICS AS TOPIC;

EID: 84947649203     PISSN: 1748670X     EISSN: 17486718     Source Type: Journal    
DOI: 10.1155/2015/210817     Document Type: Article

References (7)

1. M.-W. An, S. J.Mandrekar, and D. J. Sargent, "A 2-stage phase II design with direct assignment option in stage II for initial marker validation," Clinical Cancer Research, vol. 18, no. 16, pp. 4225-4233, 2012.
2. A. Liandgrave;evre, J.-B. Bachet, V. Boige et al., "KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with Cetuximab," Journal of Clinical Oncology, vol. 26, no. 3, pp. 374-379, 2008.
3. L. V. Rubinstein, E. L. Korn, B. Freidlin, S. Hunsberger, S. Percy Ivy, and M. A. Smith, "Design issues of randomized phase II trials and a proposal for phase II screening trials," Journal of Clinical Oncology, vol. 23, no. 28, pp. 7199-7206, 2005.
4. S. J.Mandrekar and D. J. Sargent, "Predictive biomarker validation in practice: lessons from real trials," Clinical Trials, vol. 7, no. 5, pp. 567-573, 2010.
5. B. Freidlin, L. M. McShane, and E. L. Korn, "Randomized clinical trials with biomarkers: design issues," Journal of the National Cancer Institute, vol. 102, no. 3, pp. 152-160, 2010.
6. B. Freidlin, Z. Sun, R. Gray, and E. L. Korn, "Phase III clinical trials that integrate treatment and biomarker evaluation," Journal of Clinical Oncology, vol. 31, no. 25, pp. 3158-3161, 2013.
7. B. Freidlin, E. L. Korn, and R. Gray, "Marker Sequential Test (MaST) design," Clinical Trials, vol. 11, no. 1, pp. 19-27, 2014.