Project Pragmatica: US FDA’s OCE Initiative Aims To Encourage Simple Clinical Trials
OCE Director Richard Pazdur says idea for the latest initiative stemmed from a clinical trial in lung cancer that he thought only needed to measure the impact on overall survival.
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Oncology Center of Excellence director said clinical trial participation may increase if the research questions are ‘significant to answer.’
Former NCI Director Monica Bertagnolli, who now is head of the NIH, said FDA, NCI and National Clinical Trials Network officials are working on potential clinical trial system innovations.
Overall survival is the only viable endpoint for pragmatic trials in oncology, the US FDA and a panel of stakeholders agree, although other novel endpoints could be validated over time. In the meantime, FDA says, sponsors should focus on other aspects of trials that can be streamlined.