Healthcare1/12/2024 11:00 AM
Novel medical technologies are being introduced at unprecedented rates, demanding scientific evidence of their safety and efficacy at an unprecedented pace to ensure patient safety and benefit. With success in both in-vitro/in-vivo studies, products are tested on clinical trials assessing use in humans. Predicting low-frequency side effects has been difficult because such side effects may not become apparent until many patients adopt the treatment. When medical devices fail at later stages, financial losses can be catastrophic. Testing on many people is costly, lengthy, and sometimes implausible (e.g., paediatric patients, rare diseases, and underrepresented or hard-to-reach ethnic groups).