A report published in Clinical Pharmacology & Therapeutics discusses the use of RWD (real world data) and RWE (real world evidence) in medical product applications submitted to the FDA (Food and Drug Administration). The authors note that more applications in the fields of oncology and rare diseases compared to other disease areas utilize RWE, but that this trend could change as more pharmaceutical and medical device companies expand their clinical trial design and therapeutic effectiveness strategies.
“Evaluators identified 34 instances of RWE submitted between 1954 and 2020, where 26% of instances were for oncology, 18% for hematology, and 12% for neurology. Over 50% of the products were indicated for use in rare disease or pediatric populations. 82% of products where RWE was submitted received an orphan designation. RWE was included in the product label in 61% of instances.” Read more here.
(Source: Mahendraratnam et al., Clinical Pharmacology & Therapeutics, 4/23/21)
