Clinical trial designs for anti-cancer agents are sophisticated due to the
involvement of complex etiological and pharmaceutical mechanisms, multiple potential
indications, emergent therapeutic techniques, clinical needs of long-run assessments
and observations of primary endpoints, advanced assessment standards and techniques
for disease status as well as various data capture approaches for anti-cancer agents.Also,
poor subjects’ health conditions and concomitant therapeutics and medications result in
significant challenges for data management in anti-cancer clinical trials. This chapter
will overview and describe the main operational and processing elements in the
standpoints of data management views, include global data management standards,
good trial Case Report Form (CRF) design practice to support various trial design, key
elements in data management for anti-cancer trials, management of Independent Data
Monitoring Committees in oncological clinical trials, and risk-based data control and
collaboration with relevant stakeholders in the management of oncological trials.
Keywords: Anti-cancer Drugs, CDISC Standards, Clinical Endpoints in Cancer
Trials, Clinical Trials, CRF Designing, Data Management, Data Monitoring
Committee, Data Validation and Cleaning, Oncological Studies, Risk-based Data
Management.
