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

October 28-29, 2019
  • Philadelphia, PA

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.

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The FDA’s draft guidance on master protocol design strategies to expedite the development of oncology drugs and biologics, creates new opportunity for both sponsors and sites.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

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

  • Collaborate with Stakeholders to Optimize and
    Define Master Protocols
  • Key Considerations for Planning and Designing Complex Trials
  • 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
  • Set up the Randomization Scheme within the IRT for
    Success in Complex Innovative Trials

Hot Topics for 2019:

  • Creating a Win-Win for Companies and Patients through
    Better Trial Design and Patient Engagement
  • Evaluate Multi-Pharma Master Protocols for
    Pediatric Oncology Studies
  • Round Table —
    Apply Learnings from Oncology to Other Disease Indications
  • Optimal Two-Stage Designs for Exploratory Basket Trials
  • Explore the Regulatory Considerations and Conduct of
    Global Master Protocols
  • Maximize CROs, Site Management and Site Evaluation for
    Basket Capabilities
  • Master Biomarker Screening by Learning the Insider Secrets of Patient Trial Assignments

Basket, Umbrella & Platform Trials

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

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.

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.

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

  • Collaborate with Stakeholders to Optimize and
    Define Master Protocols
  • Key Considerations for Planning and Designing Complex Trials
  • 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
  • Set up the Randomization Scheme within the IRT for
    Success in Complex Innovative Trials

Hot Topics for 2019:

  • Creating a Win-Win for Companies and Patients through
    Better Trial Design and Patient Engagement
  • Evaluate Multi-Pharma Master Protocols for
    Pediatric Oncology Studies
  • Round Table —
    Apply Learnings from Oncology to Other Disease Indications
  • Optimal Two-Stage Designs for Exploratory Basket Trials
  • Explore the Regulatory Considerations and Conduct of
    Global Master Protocols
  • Maximize CROs, Site Management and Site Evaluation for
    Basket Capabilities
  • Master Biomarker Screening by Learning the Insider Secrets of Patient Trial Assignments