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Master protocols and other innovative trial designs in inflammation and immunology to expedite clinical drug

Elena Peeva1, Anindita Banerjee1, Christopher Banfield1

  • 1Pfizer Inc., 1 Portland St, Cambridge, MA 02139, USA.

Drug Discovery Today
|March 9, 2024
PubMed

Insights

Master protocol designs, like umbrella and basket studies, are now used in inflammation and immunology trials. These innovative approaches offer cost savings and faster drug development for patients.

Area of Science:

  • Clinical trial design
  • Pharmacology
  • Immunology

Background:

  • Master protocol designs, including umbrella and basket studies, are established in oncology.
  • These designs enable simultaneous evaluation of multiple compounds or patient populations within one study.
  • Traditional randomized controlled trials can be resource-intensive and time-consuming.

Purpose of the Study:

  • To explore the application of master protocol designs beyond oncology.
  • To detail Pfizer's implementation of these designs in inflammation and immunology studies.
  • To highlight potential benefits such as cost savings and accelerated timelines.

Main Methods:

  • Review of Pfizer's recent clinical studies utilizing master protocol designs.
  • Focus on implementation in inflammation and immunology therapeutic areas.
  • Analysis of opportunities for cost and resource optimization.

Main Results:

  • Demonstration of master protocol designs' applicability in non-oncology settings.
  • Identification of significant cost and resource efficiencies.
  • Evidence of expedited timelines for new treatment evaluation.

Conclusions:

  • Master protocol designs offer a viable and beneficial alternative to traditional trial designs in inflammation and immunology.
  • These designs can accelerate the delivery of novel therapeutics to patients.
  • Pfizer's experience showcases the practical advantages of implementing master protocols.
Keywords:
basket designdrug developmentimmunologyinflammationmaster protocolplatform protocolumbrella design

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