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The American College of Cardiology and PatientsLikeMe to Bring Patient Focus to Diabetes Research and Care

Real-world, clinical insights and patient engagement central to improving health outcomes  WASHINGTON and CAMBRIDGE, MASS., November 9, 2015—The American College of Cardiology (ACC) and PatientsLikeMe have launched a partnership to explore innovative ways to make real-world patient feedback and experience more central to diabetes research and care. Focused on the ACC’s Diabetes Collaborative Registry®, the partnership will encourage people living with diabetes to offer perspectives to enhance and accelerate the registry’s research and development agenda. The announcement was made during American Diabetes Month and at the start of the week marking the International Diabetes Federation’s World Diabetes Day. The Diabetes Collaborative Registry is the first global, cross-specialty clinical diabetes registry designed to track and improve the quality of diabetes and cardiometabolic care delivered to patients across the primary and specialty care continuum. The registry’s founding industry sponsor, AstraZeneca, is also a PatientsLikeMe partner and shares the goal to bring the patient voice into the center of scientific discovery and development. ACC Executive Vice President of Science, Education, Quality and Publishing William J. Oetgen, MD, MBA, FACC, FACP said the collaboration will bring PatientsLikeMe’s expertise and engagement experience to the registry. “The Diabetes Collaborative Registry is focused on transforming the quality of …

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PatientsLikeMe and the FDA Sign Research Collaboration Agreement

WASHINGTON D.C., June 15, 2015—PatientsLikeMe and the U.S. Food and Drug Administration (FDA) have signed a research collaboration agreement to determine how patient-reported data can give new insights into drug safety. Under the collaboration, PatientsLikeMe and the FDA will systematically explore the potential of patient-generated data to inform regulatory review activities related to risk assessment and risk management. The announcement was made at the start of the Drug Information Association’s (DIA) annual meeting in Washington D.C. PatientsLikeMe Co-Founder and President Ben Heywood said the agreement is an unprecedented step toward enhancing post-market surveillance and informing regulatory science. “Most clinical trials only represent the experience of several hundred or at most several thousand patients, making it impossible to anticipate all the potential side effects of drugs in the real world. Patient-generated data give a more complete picture about a drug’s safety by providing a window into patients’ lives and healthcare experiences over time. We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier.” The cornerstone of the FDA’s post-approval drug safety surveillance is a spontaneous reporting system consisting of individual case safety reports. Reporting adverse events to the FDA is mandatory for …

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