August 3, 2023
RegenMed has had the honor of working with providers and industry around the world for many years on studies and trials. Several broad themes emerge:
National authorities recognize the negative impact on broad healthcare metrics of over-reliance on traditional forms of medical studies. The European Medicines Agency and the U.S. FDA have stressed the importance of real-world data and evidence.
Similarly, the AHRQ publication Registries For Evaluating Patient Outcomes provides an independent and thorough review of efficient study formats. The 21st Century Cures Act, Right To Try Act and similar legislative initiatives are designed to expedite the availability of safe and efficacious treatment protocols and products. This means, necessarily, improving the efficiency and lowering the costs of trials and other studies.
The U.S. government’s recently announced RECOVER initiative represents a major validation of the importance of more pragmatic study formats. RECOVER builds upon and expands a $1 billion “long-COVID” research initiative already underway at the U.S. National Institutes of Health. It encompasses several key elements of modern approaches to studies:
There will always be legitimate needs for randomized, controlled, double-blinded clinical trials. However, their cost and narrow scope – virtually all are now industry sponsored – implies little genuine support in everyday clinical decision-making. As the foregoing governmental initiatives imply, there are often other equally valuable study approaches with greater benefits to broader patient populations.
There can be little question that contemporary technology, better clinician and patient user experiences, and thoughtful study designs can support clinical decision-making leading to better outcomes across much larger population groups.
Circles are designed precisely to enable such studies of any scale or complexity – in a turnkey, clinical-grade, and low-cost manner. Please contact us to find out more.