Genetic Exposé Of Ovarian Cancer Prompts Radical Rethink Of Trial Design

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.