US FDA draft guidance standard for clinical trial imaging endpoints: More than just imaging?

Biomarkers in Medicine

Volumn 6, Issue 6, 2012, Pages 839-847

  Walovitch, Richard C ^a   Chokron, Patrick ^a   Agarwal, Sheela ^b  

^a WorldCare Clinical   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

adjudication; BICR; blinded review; DMIHP; DMIP; FDA guidance document; imaging; imaging contract research organization; independent review committee; subjective assessment

Indexed keywords

IMATINIB; SUNITINIB;

ANGIOCARDIOGRAPHY; CLINICAL RESEARCH; COST CONTROL; CYTOTOXICITY; DIAGNOSTIC ACCURACY; DIGITAL IMAGING; DOCUMENTATION; DRUG DEVELOPMENT; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; IMAGING SYSTEM; LEARNING ALGORITHM; MEDICAL SOCIETY; ONCOLOGY; POSITRON EMISSION TOMOGRAPHY; PRACTICE GUIDELINE; PROGRESSION FREE SURVIVAL; QUALITY CONTROL; REPRODUCIBILITY; REVIEW;

CLINICAL TRIALS AS TOPIC; ENDPOINT DETERMINATION; HUMANS; MOLECULAR IMAGING; PRACTICE GUIDELINES AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84870932089     PISSN: 17520363     EISSN: 17520371     Source Type: Journal    
DOI: 10.2217/bmm.12.74     Document Type: Review

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