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Developing generic templates to shape the future for conducting integrated research platform trials.

Madhavi Gidh-Jain1, Tom Parke2, Franz König3

  • 1, 55 Corporate Drive, Bridgewater, NJ, 08807, USA.

Trials
|March 22, 2024
PubMed
Summary
This summary is machine-generated.

New templates streamline integrated research platform trials (IRPs), enhancing simultaneous multi-therapy evaluation. This guide supports adaptive designs, improving clinical trial efficiency and drug development.

Keywords:
EU Patient-cEntric clinicAl tRial pLatformsIntegrated research platform trialsMaster Protocol Template

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Area of Science:

  • Clinical Trials
  • Drug Development
  • Regulatory Science

Background:

  • Clinical studies adhere to International Council for Harmonisation (ICH) E6 (R2) guidelines.
  • Integrated Research Platforms (IRPs) are gaining importance for simultaneous multi-therapy evaluation.
  • Existing templates require re-examination for modern drug development and regulatory challenges.

Purpose of the Study:

  • To develop and disseminate a suite of templates for designing Integrated Research Platforms (IRPs).
  • To provide practical guidance for adaptive platform trial designs.
  • To support the setup, design, planning, implementation, and conduct of complex platform trials.

Main Methods:

  • A collaborative effort involving regulatory medical writing, biostatistics, and EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) members.
  • Input from diverse stakeholders including academic hospitals, pharmaceutical companies, NGOs, patient groups, and SMEs over 3.5 years.
  • Development based on TransCelerate's Common Protocol Template (CPT) and statistical analysis plan (SAP).

Main Results:

  • A suite of templates for IRPs, incorporating TransCelerate CPT and EU-PEARL guidance.
  • Templates offer practical suggestions for adaptive designs, including dropping futile treatments or adding new ones.
  • A user-friendly Platform Trials Best Practices tool complements the templates, forming a comprehensive reference manual.

Conclusions:

  • The EU-PEARL templates enhance the design and understanding of IRPs.
  • The reference user manual and website aim to facilitate the creation of IRP trials.
  • Dissemination of these resources will improve the efficiency and effectiveness of platform trial design.