Clinical trials, also called contract research, medical research or research studies, determine safety and efficacy of new drugs or treatment modalities. These studies are most often multi-institutional, global trials sponsored by pharmaceutical corporations.
Strengths of the clinical trials product are: the trials are of short duration, provide educational value and if properly priced, offset expenses. Their weaknesses include the fact that they are often very labor-intensive, volatile (terminated with little notice at the discretion of the drug company) and therefore high risk.
Clinical trials, in our patient care center, are managed by our Human Subjects Core under the direction of Judith M. Jenkins RN, MSN. Each clinical trial has a division faculty member designated as site Principal Investigator (PI) and has multiple Sub-investigators. Junior faculty, interested in trial design and execution, are encouraged to become PIs.
Since its inception 14 years ago, our Human Subjects Core has successfully conducted 46 clinical trials, managed 5 federal grants, procured over 10,000 biologic samples (including 7,000 genetics samples), contributed to numerous abstracts and manuscripts, supervised six data repositories, and ensured regulatory compliance for all research endeavors of the division.. Research-experienced critical care nurses provide coverage 24 hours a day, 7 days a week. These nurses screen patients, obtain informed consent, procure specimens and foster the clinical research culture across the Surgical Critical Care platform.
Involvement in clinical trials provides practical experience within the Fellowship structure that allows the Fellow exposure to study design, implementation, IRB regulations, and subject protections. A well designed well executed clinical trials program provides significant revenue enhancement for the division. Therefore it is useful skill for the Fellow's career development.