The Democratization of Clinical Trials
Clinical trials represent the primary means to test new drugs before they become approved by the FDA for sale and marketing as a standard of care. The purpose of these trials is to test the safety and efficacy of new drugs and their combinations. Clinical trials must be performed with the highest ethical standards and must include geographically, genetically and socio-economically diverse populations. Trials provide completely free care for all participants, ensuring that any patient can participate.
However, the vast majority of cutting-edge trials are performed in elite academic tertiary care centers, requiring patients not living in the immediate vicinity to undergo burdensome travel and long stays away from home. The Guardian Research Network was developed to address these issues by bringing novel trials to community health systems where most patients are treated, effectively democratizing clinical trial access. A new digital approach was developed to consenting patients, and collecting and reporting clinical data, and a network was formed using centralized approaches to save time and expense. Real-world data is used to submit comparator control arms to the FDA to support rapid drug approvals.
Timothy J. Yeatman, M.D. is an adjunct professor of surgery at the University of Utah, where he has an active National Cancer Institute (NCI)-funded laboratory, and he is a member of the Cell Response and Regulation Program of the Huntsman Cancer Institute (HCI). He has spent the past two and a half years directing the development of an integrated cancer program for Intermountain Healthcare and its 24 hospitals, and coordinating collaborations with the University of Utah and HCI. He recently joined Phenome Health as its chief clinical officer in charge of identifying and accruing 1million participants in the Beyond the Human Genome Project (BHG).
Robert Lee Kilpatrick
MLF: Health & Medicine