By Timothy J. Yeatman, M.D. and Mark L. Watson, MD, Ph.D
Published at TheJournalof PrecisionMedicine.com
Precision medicine has been defined as a medical model that proposes the customization of healthcare – with medical decisions, practices and products being tailored to the individual patient. Precision medicine offers great promise and hope to cancer patients who seek more targeted therapies with improved response rates and lower toxicities. To accomplish this goal, many changes in the current healthcare system must be made and accepted—from data warehousing to data integration and analysis. These efforts, aimed at breaking down data silos between hospitals, will lead to the “democratization” of clinical trial access, allowing cutting edge therapeutics to be made available to all patients in their community without leaving home. Currently, the US clinical trials architecture is not well suited for the rapid identification of molecularly-defined subpopulations of cancer patients to support the next generation of “smart” trials. This is primarily because there are simply not enough patients within a small radius of existing trial centers. Furthermore, the slow and expensive drug development process results in just a small fraction of available drugs being tested and approved. Here, we propose re-engineering the clinical trials architecture to access the large frontier of cancer patient pioneers (>80%) who routinely use the local community healthcare system as their main provider, and who otherwise have little or no access to cutting-edge targeted therapies. A comprehensive solution – the Guardian Research Network (GRN) – is described that will enable pharma, diagnostic and device companies to more rapidly discover, develop and deliver their products to patients in need, and enable wide adoption by community physicians.