Sarah Owermogle, Politico: August 13, 2018.
[…] FDA LOOKS TO MODERNIZE CANCER TRIALS — The FDA issued guidance on Friday intended to speed up certain early and mid-stage clinical trials for oncology drugs by merging elements typically found in phase 1 and phase 2 trials. Studying multiple patient groups separately for criteria like safety and efficacy has the potential to lower costs and add efficiency, Commissioner Scott Gottlieb said in a statement.
Initial reviews were positive: “There is no tablet that got handed down from God to Moses that said drug trials must be conducted in three conventional phases,” said Dana-Farber’s George Demetri, who chairs the American Association for Cancer Research’s government affairs committee. The new approach, known as expanded cohort trials, could allow researchers to be more nimble, Demetri said — more easily spotting a drug’s effect on specific cancers or realizing earlier that it isn’t working.
Vanessa Lucey said the Cancer Research Institute, where she directs the venture fund and clinical accelerator, has itself moved toward these kinds of studies.
The costs: But while the proposed changes could streamline certain cancer trials — the guidance is limited to cases in which a drug’s benefits justify an increased risk, like for cancers that have no cure — there still could be additional costs. In the guidance, the FDA warned that trial sponsors would need to streamline logistics and data collection, and incorporate plans to assess data in real time.
“What’s important about this guidance is it’s trying to come to some kind of political compromise,” said Diana Zuckerman, president of the National Center for Health Research. “It’s trying to do two things that usually conflict — speed and safety don’t go together, usually.” She added: “It’s OK to say they’re going to do this to speed up drug development, but some patients are definitely going to get harmed.” […]
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