Patient Experience Is Key Element For Oncology Dose Optimization

The push for dose optimization in oncology should incorporate patient experience data, a Friends of Cancer Research White Paper recommends. ‘Tolerability’ is a key element to define in early development, and patient-reported outcomes can help.

Dose optimization
• Source: Shutterstock

Oncology drug developers should gather patient-reported outcomes (PROs) as part of their efforts to optimize dosing in early development, a Friends of Cancer Research white paper recommends.

FOCR released the white paper in conjunction with its annual meeting this month. It was developed by a group of industry, academic, patient and regulatory participants as part of the organization’s work to support the US Food & Drug Administration’s “Project Optimus” initiative to encourage better dose selection for new cancer therapies

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approval Standards

More from Pathways & Standards

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.