Adaptive Design Alternatives

How to Maximize the Effectiveness of Phase I and Phase II Oncology Studies

Adaptive trial designs are a hot topic in oncology drug development, especially in phase I and phase II studies. An adaptive trial provides the greatest impact when you don’t have enough data to design a traditional trial with confidence – which is common in early stage studies.

Medelis can analyze your drug and create an adaptive trial design alternative for your phase I or phase II study. This short-term consulting engagement can have a dramatic impact on your clinical development path – delivering faster data to reduce your time to market.

Value to Sponsors

Adaptive trial designs in phase I and phase II oncology studies can result in:

  • A greater chance of phase III success by obtaining superior information in phase I and phase II
  • Fewer patients receiving ineffective doses
  • An opportunity to combine proof of concept with dose escalation in particular cases
  • Fewer patients required in phase II and in phase III
  • Faster study outcomes
  • Reduced time to market; reduced spending during development

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