5 Clinical Supply Tips For Handling Investigator Initiated Trials

Clinical supply teams have been managing a surge in packaging, labeling, and distribution projects due to a rapidly increasing number of investigator initiated clinical trials. Theses are studies in which the primary investigator also serves as the study sponsor with investigational drugs or devices typically donated by a manufacturer. Several different data points indicate a growing trend that has implications for supply chain professionals. First, an analysis of protocols submitted to the U.S. National Institutes of Health (NIH) shows the number of industry funded clinical trials sponsored by academic institutions nearly tripled from 100 trial protocols submitted in 2011 to 298 protocols submitted in 2014. Compiled from information posted on www.ClinicalTrials.gov, the data show more than 900 active Investigator Initiated Trials (IITs) worldwide.