Real-world data (RWD) and real-world evidence (RWE) have become an increasingly important part of the medical product development landscape. These tools can enable sponsors to optimize clinical trial designs and demonstrate the real-world effectiveness of new medical products. Part 2 of this three-part blog series outlines a fit-for-purpose approach to RWE. (See Part 1: What...
The 21st Century Cures Act (Cures Act)1 signed into United States law in 2016 aims to accelerate medical product development and bring innovations to patients faster through real-world evidence (RWE) to support regulatory decision making. Incorporating real-world data (RWD) and real-world evidence (RWE) can help pharma and biotech companies optimize clinical trial designs and demonstrate...
Accelerated by increasing acceptance of decentralized medicine ushered in by the pandemic, the digital therapeutics (DTx) market is rising exponentially. In January 2022, a Research And Markets analysis valued the 2021 global market for DTx at $3.35 billion and estimated it would reach $12.1 Billion by 2026.1 In March 2022, Insider Intelligence revised its previous...
The realm of digital medicine is one that is always moving. As regulatory agencies try to keep up with the changing landscape, how can companies get the best out of new digital medicines and therapeutics? International Clinical Trials, May 2022, pages 18-21. © Samedan Ltd
Over the past decade, the development of digital medicines has been steadily gaining momentum, with real-world data demonstrating that these approaches can help improve patient lives. The COVID-19 pandemic further propelled the digital medicines industry forward by shining a light on the need for innovative treatment options and accelerating the adoption of technologies that integrate...
Typically, when people talk about a full-service contract research organization (CRO) they mean a group that handles every aspect of a clinical study, supplying the personnel, the systems, and the processes. The sponsor is spared all operational involvement with the full-service model, simply receiving key information at specified intervals. This model works very well for...
The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. While some of the dates have been extended1 to allow for...
Introduction The strongest foundation for successful widespread marketing of any diagnostic is evidence of clinical utility. Clinical validation – determining a test’s ability to diagnose a health condition or predict risk of clinical outcomes – may fail to convince physicians and especially healthcare payers to accept a new diagnostic. Failure to gain payer acceptance may...
Background Point-of-care (POC) tests offer significant convenience for patients and physicians, as well as cost-savings for payers. Yet, achieving regulatory approval can be daunting. Sponsors not only have to show safety and efficacy, they have to prove that the test is simple and poses an insignificant risk of an erroneous result. Assembling such proof requires...
Background Colorectal cancer (CRC) is the second most deadly form of cancer – although it is among the most curable and the easiest to detect in its early stages. The reason: patients notoriously avoid colonoscopy, placing themselves at unnecessary risk. Our client developed a unique solution – a multi-target, noninvasive screening test that could be...