Medical device companies may find success in the use of real-world evidence. In fact, the top concern for companies and sponsors was getting “robust, standardized data” according to a study by the Tufts Center for the Study of Drug Development.
The FDA “seems receptive to the data that's coming in to support the expansion of FDA-approved indications for use,” she said. “Randomization controls bias almost automatically,” she added. “But there are other ways to control bias. As long as it's robust and you have some reliability data, [the agency] may take it.”