Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies. If Dr. Robert M. Califf, center, is confirmed by the Senate, he will again take the reins of an agency that is responsible for more than $2.8 trillion worth of food, medical products and tobacco.
Dr. Califf is one of the most prestigious experts in the field of clinical trials, which is an important reason for his nomination. In the final analysis, the pharmaceutical industry needs to evaluate the efficacy of new drugs through clinical trials for the benefit of patients. When an FDA Commissioner spends most of his career on clinical trials, knowing what a good clinical trial is, this in itself sends a positive signal.
During the last time he was in charge of the FDA, Dr. Califf forward-looking advocated "real world evidence", collecting health information in a way more in line with the digital age, and answering questions that are difficult to answer in traditional clinical trials. These innovations are not intended to replace traditional clinical trials, but can complement the latter and reduce the failure rate of clinical trials. "Even if it has entered the stage of human clinical trials, more than 90% of them (therapies under development) still end in failure." And "Any factor that can reduce the failure rate from 90% to 80% or 70% will have a huge impact on clinical medicine." Dr. Califf said.
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