Cancer and Blood Diseases Center

Translational Research Training

In addition to studies in basic and or clinical research as outlined above, training for fellows who choose to pursue a focus in translational research should include coursework (available at CHB through the Clinical Research Program (CRP) and the Translational Research Program (TRP) as well as through Harvard Catalyst) that introduces and educates the fellow in the following topics:

• The IND/IDE regulatory process
• Investigator responsibilities in FDA-regulated research
• Biomarker development in the clinical trial setting
• Data and safety monitoring boards vs. plans
• Delegation of responsibility/building a study team
• Negotiating relationships with industry: Conflict of interest, technology transfer, IP issues, contracts/budgets

Participation in an intensive clinical trial or clinical investigation course such as the Harvard Catalyst Intensive Training in Translational Medicine course (2 week course, offered annually in July) or the Introduction to Clinical Investigation course (5 day course), offered three times per year should be encouraged. Introduction to Statistical Genetics (CRP Education core), and an overview of Clinical Pharmacology could also be valuable for the fellow oriented towards translational research.