Key Data Management Elements in Clinical Trials for Oncological Therapeutics

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.