{"id":50503,"date":"2022-11-04T14:02:13","date_gmt":"2022-11-04T13:02:13","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/new-approach-to-clinical-trial-design-helps-medical-devices-better-meet-patient-needs-and-priorities\/"},"modified":"2022-11-04T14:02:13","modified_gmt":"2022-11-04T13:02:13","slug":"new-approach-to-clinical-trial-design-helps-medical-devices-better-meet-patient-needs-and-priorities","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/new-approach-to-clinical-trial-design-helps-medical-devices-better-meet-patient-needs-and-priorities\/","title":{"rendered":"New Approach to Clinical Trial Design Helps Medical Devices Better Meet Patient Needs and Priorities"},"content":{"rendered":"
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\nScience of Patient Input Provides a Systematic Approach to Collect, Analyze, and Apply Patient Preferences into the Medical Device Development and Regulatory Process<\/i><\/b>\n<\/p>\n

ARLINGTON, Va.–(BUSINESS WIRE)–A Medical Device Innovation Consortium (MDIC) program today released a new framework that provides U.S. medical device companies a systematic approach for patient-focused clinical trial design to better meet patient needs and priorities. The Science of Patient Input<\/a> (SPI), with representatives from the U.S. Food and Drug Administration (FDA), patient advocacy groups, and the medical device industry, developed the approach so that the studies used to evaluate medical devices can better align with patients\u2019 interests.\n<\/p>\n

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\nThe patient-centered framework was developed to help inform researchers interested in conducting rigorous patient preference studies for medical device design, development, evaluation, and regulatory submissions. The approach is detailed in a new SPI framework, \u201cUsing Patient Preference Information in the Design of Clinical Trials<\/b>.\u201d <\/b>The framework describes the first and only collection of scientifically rigorous methods for integrating patient preferences into clinical trial design.\n<\/p>\n

\nAccording to MDIC Science of Patient Input (SPI) Program Director Kert Gunasekaran, \u201cScientific and technological advancements are accelerating device innovation, but ensuring access to those new therapies takes regulatory science. Our SPI program embraces the opportunity for industry to incorporate patient input more systematically into the process of developing products, enhancing our pathways to deliver unmet needs for patients, and ultimately speeding access to new therapies.\u201d\n<\/p>\n

\nBefore approving a new medical device, regulators evaluate its safety and effectiveness, which includes consideration of the successful achievement of predetermined clinical trial results. To date, patients have had limited input on how clinical trial success is defined.\n<\/p>\n

\nTo ensure patient preferences are included, MDIC encourages clinical trial sponsors to incorporate patient perspectives into the total product life cycle, from research and development, to clinical trial design, and regulatory decision-making.\n<\/p>\n

\n\u201cPatient preferences may differ from those of clinicians and device manufacturers,\u201d said Dr. Shelby Reed, professor of population health sciences and medicine at Duke University. \u201cPatients and their families have a deep and personal understanding of what it\u2019s like to live with a disease, and they often have valuable insights on how a device could affect their quality of life.\u201d\n<\/p>\n

\nPatient preference can often be contrary to conventional assumptions. Patient input may reveal patients\u2019 willingness to take a substantial risk that the device may not work in exchange for the potential benefits. Conversely, patient input may suggest that a treatment must provide significant, not-yet-identified benefits before patients would be willing to accept the risk of a new approach.\n<\/p>\n

\nBecause there are unique challenges to this novel approach to collecting, analyzing, and applying patient preferences to clinical trial design, SPI has developed data-driven approaches for regulatory and clinical teams to:\n<\/p>\n