Building a new foundation for oncology clinical trials

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The COVID-19 pandemic disrupted oncology clinical trials, and drug developers and regulators, including the FDA, continue to look for ways to catalyze clinical trial innovation.  The FDA has been “vigilant as they always are to make sure that there is strong science, but they are much more open both in study design, alternative execution methods and the use of real-world evidence (RWE) and retrospective data,” said Jeff Elton, CEO of ConcertAI.

ConcertAI is now in a five-year collaboration with the FDA that involves RWE and AI to support regulatory decision-making. “One of the first projects is looking at cardiovascular adverse events that occur in [immuno-oncology]-treated patient populations,” Elton said.

One factor contributing to the evolution of oncology clinical trials is the change in interactions between sponsors and regulatory agencies. “It is materially diffe…

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Prioritizing translational research is changing drug development for patients and doctors, for good

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Twelve years. That’s the average amount of time it takes for a viable therapeutic to make it from the research stage to approval for market. In that time, 2.4 million Americans will suffer the effects of severe acute pancreatitis, many of which can be long-lasting and debilitating. Roughly 240,000 of these patients will die as a result of the illness. This is from just one potentially treatable disease.

With more Americans falling ill to preventable diseases each year, the pressure has never been greater for researchers and developers to find ways to create higher-quality therapeutics in less time to save and improve lives. Surprisingly, the way forward is not to change the approval process but to improve the research and development methods applied at each pipeline stage.

The logjam isn’t the approval process — it’s the methods

At first glance, it is easy to assume …

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