The landscape of today’s clinical trials is ever changing, posing greater challenges for sponsors, investigators and FDA alike. Challenges include increased complexity, novel therapies, large multi-site trials, inclusion of vulnerable patients, trials conducted outside of the United States, and outsourcing of various trial related responsibilities. In response to these complexities, FDA is implementing several new initiatives to maintain better oversight, and sponsors and investigators will need to be more vigilant throughout all phases of a clinical trial in order to achieve success.
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