Proposal Development
Industry-Sponsored Clinical Trials
A clinical trial is defined by the Public Health Service as "a controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions." Clinical trials are frequently multicentered, i.e., investigators from a number of institutions follow the same study protocol, and results from all investigators are pooled for analysis.
Staff in the Office for Business and Industry Contracts (OBIC) at the Research Foundation work with investigators and sponsors to develop study agreements acceptable to the investigator and to the university. The Industry-Sponsored Clinical Trials: Checklist outlines the steps involved in establishing a clinical trial project.