Some practical considerations for phase III studies with biomarker evaluations

Journal of Clinical Oncology

Volumn 32, Issue 8, 2014, Pages 854-855

  Goteti, Sasikiran ^a   Hirawat, Samit ^a   Massacesi, Cristian ^b   Fretault, Nathalie ^b   Bretz, Frank ^a   Dharan, Bharani ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b Novartis Oncology   (France)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; BUPARLISIB; TUMOR MARKER;

ADVANCED CANCER; BREAST CANCER; CANCER PATIENT; CANCER STAGING; HUMAN; LETTER; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; METHODOLOGY; NEOPLASM; NOTE;

CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; NEOPLASMS; RESEARCH DESIGN; TUMOR MARKERS, BIOLOGICAL;

EID: 84899639053     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2013.53.7613     Document Type: Letter

References (6)

1. Freidlin B, Sun Z, Gray R, et al: Phase III clinical trials that integrate treatment and biomarker evaluation. J Clin Oncol 31:3158-3161, 2013
2. Bretz F, Maurer W, Brannath W, et al: A graphical approach to sequentially rejective multiple test procedures. Stat Med 28:586-604, 2009
3. Maurer W, Bretz F: Multiple testing in group sequential trials using graphical approaches. Stat Biopharm Res 5:311-320, 2013
4. Brannath W, Zuber E, Branson M, et al: Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology. Stat Med 28:1445-1463, 2009
5. Food and Drug Administration: Guidance for industry: Enrichment strategies for clinical trials to support approval of human drugs and biological products, December 2012. www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM332181.pdf
6. Food and Drug Administration: Guidance for industry: Adaptive design clinical trials for drugs and biologics, February 2010. www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf