MedVector to Clarify Misunderstood FDA Guidance at J.P. Morgan Healthcare Conferences
LOS ANGELES--(BUSINESS WIRE)--Dec 20, 2022--
By the FDA’s admission, the clinical trial system is broken and no longer “serves the interests of patients.” More than 75% of patients would consider participating in a clinical trial, yet only 9% are typically invited. When done right, clinical trials have the potential to produce life-changing results.
Investors gathering in San Francisco the week of Jan. 9, 2023 for events surrounding the 41st Annual J.P. Morgan Health Care Conference will hear about a new FDA-backed approach to increase participant enrollment that doesn’t treat patients like big data by instead engaging a patient’s treating physician.
Scott Stout co-founded MedVector, a connectivity platform that empowers clinical trial sites to efficiently gain access to more qualified clinical trial participants through treating physicians, based on his own experience.
Stout was confined to a wheelchair in his 30s when he lost the ability to walk. No one could correctly diagnose why he had become immobile until he was lucky enough to be in the right place at the right time. While admitted to the hospital, he met world-renowned clinical research rheumatologist Dr. Orrin Troum, who determined he had a type of juvenile arthritis that caused severe swelling in his hip joints. Four hours after taking a new medication, Stout was walking again. He participated in a clinical trial run by Dr. Troum, which opened his eyes to the industry. He started MedVector to change the paradigm that treating physicians only have imperfect options available to them. By doing so, he saw an opportunity to remove traditional bottlenecks that hinder the industry and hamstring the number of qualified patients who participate in trials.
“The clinical trial industry has been self-regulated by fear. Even perceived solutions like decentralized clinical trials (DCTs) are great in theory, but a lack of regulatory clarity makes them challenging to implement,” said Stout, Co-Founder and CEO of MedVector. “Our approach is the opposite of DCT, and instead of bringing the study to the participant, we are bringing the participant to the clinical trial site, virtually. This FDA-supported solution gives access to patients otherwise siloed behind treating physicians who don’t refer to clinical trials.”
MedVector found that the industry has misinterpreted FDA guidance regarding the relevance of the patient location when using digital tools like telemedicine. The author of that guidance, former FDA Associate Office Director Jonathan Helfgott, is now a MedVector advisor and has validated the company’s approach.
Stout and Craig Lipset, Executive Advisor at MedVector and the designer of the industry’s first fully virtual clinical trial, were the driving force behind MedVector’s poster competition win at CNS Summit 2022. The peer-reviewed concept will be shared in further depth at the events in San Francisco.
Learn more about how MedVector brings the patient to the study without requiring the physician to give away control of the patient relationship.
MedVector is a connectivity platform that empowers clinical trial sites to efficiently gain access to more qualified clinical trial participants through treating physicians. MedVector’s team of healthcare, tech, and financial entrepreneurs is building relationships, breaking barriers, and working with industry leaders to improve the clinical trial enrollment process without reinventing it. Learn more at medvector.com.
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Gregory FCA on behalf of MedVector
KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: FDA PHARMACEUTICAL HEALTH CLINICAL TRIALS
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PUB: 12/20/2022 09:55 AM/DISC: 12/20/2022 09:56 AM