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More Cures If Local Physicians Can Conduct Clinical Trials



(p. A17) The good news is that technology innovations are moving us toward modern clinical trial designs. Electronic health records, now common in U.S. medical practices, allow physicians to collect timely and detailed data that could be used for exploring ways of bringing clinical research directly to patients. Those records are becoming the technological building blocks of a new research model based on real-world evidence, which aims to provide insights regarding the usage and potential benefits or risks of a drug by analyzing patient data collected as part of routine delivery of care.

Real-world evidence captures the experience of real-world patients, who are generally more diverse than the selective cohorts enrolled in clinical trials. Additionally, real-world data from electronic health records may be used after a drug's approval to answer important questions about its use. Researchers can, for example, search through anonymized data from patients taking a specific cancer drug to see whether those with a certain tumor mutation respond better or worse than other patients. Such information could help doctors personalize therapies based on the patient's genomic makeup.

Moving clinical research to a doctor's office, the point of routine care, may also address the difficulties patients and doctors face with off-label drugs. If local physicians can participate in conducting real-world randomized clinical trials in their own practices, new uses of approved drugs could be carefully studied, potentially generating evidence supporting approval of a new use. Real-world clinical trials could also limit disruptions to patients' lives by reducing the need for long-distance travel.



For the full commentary, see:

Amy Abernethy and Sean Khozin. "Clinical Drug Trials May Be Coming to Your Doctor's Office; Electronic medical records make possible a new research model based on real-world evidence." The Wall Street Journal (Weds., Sept. 13, 2017): A17.

(Note: the online version of the commentary has the date Sept. 12, 2017.)






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