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NASH Drug Development Guidance Encourages Sponsors To Adopt Innovative Trial Designs

 
• By Michael Cipriano

Although guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.

Liver

As US FDA Commissioner Scott Gottlieb has touted the use of seamless clinical trial designs, the agency appears to promote the concept in a new draft guidance on developing drugs for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

In the guidance published Dec. 3 that otherwise contains mostly expected information, the agency says that, "Sponsors could use innovative designs to combine phase 2 and phase 3 trials (e.g., a trial design with an initial dose response exploration phase followed by continuation at a selected dose or doses)

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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
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