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Plan, Design, and Manage Complex Trials Through Innovative Use of Master Protocols

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The FDA’s draft guidance on master protocol design strategies to expedite the development of oncology drugs and biologics, creates new opportunity for both sponsors and sites.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 Trials 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.

GAIN CRITICAL INSIGHTS AND STRATEGIES TO MASTER EMERGING COMPLEX TRIAL PROTOCOLS:

  • Collaborate with Stakeholders to Optimize and Define Master Protocols
  • Explore Key Considerations for Planning and Designing Complex Trials
  • Navigate Through Multi-Stakeholder Challenges with Novel Clinical Trial Designs
  • Deep Dive into Lung-MAP—Adapting to the Changing Scientific Environment
  • Operationalize Basket and Umbrella Trial Administration – NCI Perspective Update
  • Review Acceptable Models for Statistical Design in Adaptive Trials
  • Accommodate Flexible Protocol Design in Trial Management through IRT and Data Collection
  • Master Biomarker Screening by Learning the Insider Secrets of Patient Trial Assignments

Hot Topics for 2019:

  • Explore the Regulatory Considerations and Conduct of Global Master Protocols
  • Evaluate Multi-Pharma Master Protocols for Pediatric Oncology Studies
  • Apply Learnings from Oncology across Other Disease Indications
  • Mitigate Costs and Excessive Labor in Master Protocols
  • Maximize CROs, Site Management and Site Evaluation for Basket Capabilities
  • Manage Multi-Manufacturer Trial Contracts in a Competitive Market Place

Basket, Umbrella & Platform Trials

Plan, Design, and Manage Complex Trials Through Innovative Use of Master Protocols

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 Trials 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.

GAIN CRITICAL INSIGHTS AND STRATEGIES TO MASTER EMERGING COMPLEX TRIAL PROTOCOLS:

  • Collaborate with Stakeholders to Optimize and Define Master Protocols
  • Explore Key Considerations for Planning and Designing Complex Trials
  • Navigate Through Multi-Stakeholder Challenges with Novel Clinical Trial Designs
  • Deep Dive into Lung-MAP—Adapting to the Changing Scientific Environment
  • Operationalize Basket and Umbrella Trial Administration – NCI Perspective Update
  • Review Acceptable Models for Statistical Design in Adaptive Trials
  • Accommodate Flexible Protocol Design in Trial Management through IRT and Data Collection
  • Master Biomarker Screening by Learning the Insider Secrets of Patient Trial Assignments

Hot Topics for 2019:

  • Explore the Regulatory Considerations and Conduct of Global Master Protocols
  • Evaluate Multi-Pharma Master Protocols for Pediatric Oncology Studies
  • Apply Learnings from Oncology across Other Disease Indications
  • Mitigate Costs and Excessive Labor in Master Protocols
  • Maximize CROs, Site Management and Site Evaluation for Basket Capabilities
  • Manage Multi-Manufacturer Trial Contracts in a Competitive Market Place