CBER’s 2021-2025 Strategic Plan Features Advances in Real-World Data
The FDA’s Center for Biologics Evaluation and Research (CBER) has released a strategic plan for 2021-2025 that outlines how the center will use advances in science and technology to help speed product development.
CBER plans to encourage more use of real-world data (RWD) in regulatory submissions by promoting a standardized format for sponsors. This will allow CBER to better track how real-world evidence is used to “assess effectiveness or safety outcomes in randomized clinical trials or in observational studies,” the center says. The agency is also focused on increasing the use of complex innovative designs in trials, the plan says.
CBER will also urge trial sponsors to develop patient-reported outcome instruments that “can be used in trials to directly measure the effect of a medical treatment by how the patient feels and functions” without the needed for a healthcare provider or clinician. “Integrating these measures into the design of a clinical study is one way to enhance a patient’s assessment of a medical product’s effects,” the center says.
In addition, the CBER flags its increased use of new technologies during product reviews and its greater reliance on modeling and simulations.
Model-Informed Drug Development approaches, for example, “can improve clinical trial efficiency, increase the probability of regulatory success and optimize drug dosing/therapeutic individualization in the absence of dedicated trials,” the center says. And once a product is approved, artificial intelligence and machine learning can be used to comb through RWD to improve postmarket surveillance for adverse events.
Read the 2021-2025 Strategic Plan here: https://bit.ly/3scgA1K.