The workflow of evaluation of drug efficacy and safety using medical imaging information in clinical trials

Abstract

Medical imaging in clinical trials is the essential surrogate endpoint for evaluation of drug efficacy and safety.
Imaging core laboratory builds the comprehensive process of imaging evaluation under the guideline such as Food and Drug Administration（FDA）guidance. DICOM data collection has a rule of evidence-based condition for same image quality by the medical imaging devices such as CT, MRI, PET, SPECT, and the US. DICOM de-identification for clinical trials guided by DICOM standard（The DICOM standards committee Working Group 18（WG18）wrote Supplement 142）.
Detailed DICOM masking rule is identified in this DICOM standard supplement such as de-identification,pseudonymization, and anonymization. Various criteria represented such as Response Evaluation Criteria in Solid Tumors （RECIST）1.1 for drug efficacy and safety have introduced with recently advanced computer assisted lesion management software systems. These big data in imaging clinical trials are managed not only local PACS but also cloud imaging storage and managing with Vendor Neutral Archiving（VNA）and Quality Management Systems（QMS）system.
In this educational paper, we introduce the advanced workflow of evaluation of drug efficacy and safety with application technique of medical imaging and IT cloud solutions.