Introduction: The field of wound care has been facing major challenges in generating robust evidence of safety and efficacy for pre- and on-market therapies through traditional randomized controlled trials (RCTs) for FDA and CMS. While RCTs are the gold standard for clinical evidence generation, the enormous costs and time required for adequately powered wound care RCTs present a significant bottleneck in bringing innovative therapies and devices to patients in need. Numerous other fields in medicine such as oncology and cardiometabolic diseases have faced similar challenges with RCTs and have been increasingly leveraging real-world data (RWD) from sources such as electronic health records (EHR) and claims to accelerate and lower the cost of evidence generation for regulatory approvals and coverage decisions. For example, RCT designs using RWD to increase statistical power and reduce required enrollment are enabling smaller, shorter trials in diverse therapeutic areas. Adoption of these approaches in wound care can help solve the current evidence crisis and help the field to achieve rapid and cost-effective evidence generation across the product lifecycle including regulatory approvals and coverage decisions.
Methods: Droice Labs has developed real-world data clinical trial (rwCT) approaches that produce evidence as robust as traditional RCTs while significantly lowering costs and time by meeting stringent FDA requirements for RWE. Without meeting these requirements, such studies cannot be accepted for primary evidence by agencies like FDA or CMS. Droice’s dedicated AI technologies - AI middleware* and RWD traceability* - generate reliable RWD-derived study data that meets FDA requirements for RWD reliability. Droice’s and FDA formally discussed how these technologies and approaches enable RWD use in regulatory clinical trials - see press release: https://finance.yahoo.com/news/droice-labs-discusses-superlineage-real-150000597.html
Results: This presentation will show how Droice AI technologies have been implemented on diverse RWD sources across the globe to produce reliable RWD for rwCTs in various therapeutic areas like to support clinical development and market access for multiple big pharma, biotech, and device companies. Several rwCT examples will be discussed which achieve 30-50% reductions in required enrollment and 30-50% lower trial costs.
Discussion: This presentation will inform the wound care community of rwCT approaches to lower the cost and time for trials while maintaining full scientific and regulatory rigor and provide insights from Droice’s recent discussions with FDA and CMS on RWE reliability requirements for regulatory and coverage decision-making.
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