New Investigator Clinical Trials Course

NCIC Clinical Trials Group

Learning Objectives

Upon completion of the course, participants will be able to:

List the prerequisites of preclinical studies necessary for the conduct of clinical trials;
Define and describe the phases of clinical development of therapeutics including endpoints and fundamentals of statistical analyses;
Define the term 'biomarker' and list the preclinical and clinical criteria for selection of a biomarker for further study in a clinical trial;
List and describe the different types of biomarker studies in clinical research and the principles of statistical analyses of these studies;
Undesrtand the rationale behind the inclusion of quality of life as an outcome measure in clinical trials and the associated principles of data collection and analysis;
Understand the rationale behind the inclusion of economic analysis as an endpoint in clinical trials and the associated principles of data collection and analysis;
Describe the general principles of data collection, database creation and analysis in a clinical trial;
List the organizations and documents that define the regulatory standards in Canada and internationally and describe aspects of clinical trial design and conduct that address these standards;
List key components of contract negotiation; and,
Describe the research opportunities for investigators that exist at the NCIC Clinical Trials Group.