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Plan, Design, and Manage Complex Trials Through Innovative Use of Master Protocols — Drive Patient-Centered Approaches that Enable Accelerated Access to New Therapies

October 28-29, 2019
  • Philadelphia, PA

Adaptive trials, including basket, umbrella and platform trials, are some of the fastest growing areas for clinical innovation. These complex protocols allow life sciences companies to expand patient pools by allowing more patients to have accelerated access to treatment therapies in many disease indications.

The FDA’s draft guidance on master protocol design strategies to expedite the development of oncology drugs and biologics, creates new opportunity for both sponsors and sites. Although originating in oncology, master protocols are beginning to extend into other disease indications, such as immunology, creating a new world of possibility for patient treatment.

CBI’s Basket, Umbrella, & Platform Trial Innovation convenes industry experts to overcome trial complexities and operationalize strategies to plan, design, and manage basket, umbrella and platform trials. Explore new trial formats, legal hurdles, patient recruitment challenges and other operational considerations to prepare for and maintain clinical trial protocol success.

Key Takeaways:

  • Efficiently operationalize basket and umbrella trials
  • Ensure your team is prepared and trained for
    emerging clinical formats
  • Overcome the protocol complexities of large scale
    umbrella and basket trials
  • Manage multi manufacturer trial contract; protecting legal commitments, proprietary data, and a competitive market place
  • Master biomarker screening by learning the insider secrets of patient trial assignments
  • Mitigate costs and excessive labor in basket and umbrella trials

Basket, Umbrella & Platform Trial Innovation

Plan, Design, and Manage Complex Trials Through Innovative Use of Master Protocols — Drive Patient-Centered Approaches that Enable Accelerated Access to New Therapies

Adaptive trials, including basket, umbrella and platform trials, are some of the fastest growing areas for clinical innovation. These complex protocols allow life sciences companies to expand patient pools by allowing more patients to have accelerated access to treatment therapies in many disease indications.

The FDA’s draft guidance on master protocol design strategies to expedite the development of oncology drugs and biologics, creates new opportunity for both sponsors and sites. Although originating in oncology, master protocols are beginning to extend into other disease indications, such as immunology, creating a new world of possibility for patient treatment.

CBI’s Basket, Umbrella, & Platform Trial Innovation convenes industry experts to overcome trial complexities and operationalize strategies to plan, design, and manage basket, umbrella and platform trials. Explore new trial formats, legal hurdles, patient recruitment challenges and other operational considerations to prepare for and maintain clinical trial protocol success.

Key Takeaways:

  • Efficiently operationalize basket and umbrella trials
  • Ensure your team is prepared and trained for
    emerging clinical formats
  • Overcome the protocol complexities of large scale
    umbrella and basket trials
  • Manage multi manufacturer trial contract; protecting legal commitments, proprietary data, and a competitive market place
  • Master biomarker screening by learning the insider secrets of patient trial assignments
  • Mitigate costs and excessive labor in basket and umbrella trials