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Genentech Wants Other Firms' Compounds For Mass Pediatric Cancer Screening

 
• By Sue Sutter

Master protocol for Phase I/II screening trial could make development more efficient, but concerns about regulatory obligations, lack of registrational intent and infrastructure complexity – as well as firms' willingness to share – may be hurdles to participation.

Master protocols could allow pediatric cancer trials to become a more proactive and efficient drug development exercise rather than the regulatory-driven, reactive approach that has long guided investigation of new oncologic agents for use in children and adolescents.

However, the ability to accomplish this task may depend upon a number of factors, including the willingness of sponsors to share their therapeutics for pediatric studies conducted under an umbrella protocol and

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