FDA releases new app aimed at integrating patient-generated data with clinical trial design

November 11, 2018


Clinical trials are a critical bridge between the worlds of scientific discovery and patient care. Billions of dollars and countless hours of empirical investigation go into this last step of turning a therapeutic concept into a viable drug or device.  While the emphasis of this empirical investigation has classically been centered in the hard sciences, regulatory agencies, pharmaceutical companies, and clinical researchers increasingly recognize and value a long-overlooked component to these trials: the patients themselves.  The FDA recently released “MyStudies,” an app that sources and integrates patient information and experiences related to a given therapy.  Patients who download the app are able to view ongoing clinical trials and even provide their experience with a new drug or device.  This app will undoubtedly aid market research efforts and potentially widen profit margins for the biotech and pharmaceutical industries. However, in a less cynical interpretation, it heralds an age where the patient gets a seat at the table, where their voice is heard, and where they can make an impact on the trajectory of modern medical science.



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