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Latest From Recro Pharma, Inc.
Cell/Gene Therapies: US FDA Wants ‘Quantitative Correlation' Between Surrogate And Clinical Outcome, Former Reviewer Says
When weighing accelerated approval, the FDA wants to see that ‘X change in the surrogate translates into Y change in the clinically meaningful outcome,’ Parexel’s Steve Winitsky says. CBER Director Peter Marks opines on the types of therapeutic settings where accelerated approval is best suited, and what happens when a confirmatory trial disappoints.
The acceleration of efforts to increase diversity among clinical trial subjects is expected to continue in 2023. Furthermore, many executives hope for greater inclusivity within companies, from new recruits to leadership.
Neuroscience and oncology fuel high hopes for therapeutic R&D progress among 90-plus surveyed biopharma industry leaders.
From synthetic data to real-world data, from patient engagement to patient stratification, from combination trials to master protocols and from fully decentralized through hybrid to onsite trials, the world of clinical development is undergoing major changes. Fifty executives share their predictions around clinical trial trends for the year ahead.
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