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Roche Oncology Trials Designed For “Learning On The Go”

 
• By Bridget Silverman

Roche is innovating in the structure of clinical development to manage the increasingly complex knowledge of cancer biology, using adaptive trial designs and extensive analysis of responders to find biomarkers that can inform, adjust and enrich clinical studies in a continually iterative process of “learning on the go.”

Roche/Genentech Inc. is using “smart development” strategies to manage the increasing complexity of oncology development by allowing the company to “learn on the go” – rapidly and efficiently moving clinical development forward using biomarkers and parallel clinical trial designs that continue to feed information back to the company, which can then modify other studies in response.

That’s a useful innovation for the oncology market leader, which presented new data on nine approved and 18 investigational products...

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• By Vibha Sharma

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Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

More from R&D

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
• By Neena Brizmohun

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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.