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FDA Focuses On Innovative Trial Designs

The US Food and Drug Administration (FDA) is seeking stakeholder input on the use of complex innovative designs (CIDs) in drug development and regulatory decision-making. The agency intends to launch a CID pilot programme by the end of fiscal year 2018 and publish draft guidance approximately one year later. The FDA spoke about its plans relating to CIDs at a public meeting in March. Molly Fellin Spence at Clarivate Analytics discusses that the goal of the CID pilot programme is to facilitate the use of complex, Bayesian, and other novel clinical trial designs.