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Dynamic development paths for expanding a proof-of-concept study to explore dose range.

Qiqi Deng1, Xiaofei Bai1, Naitee Ting1

  • 1Department of Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc, 900 Ridgebury Road, Ridgefield, CT 06877, USA.

Statistics in Medicine
|June 22, 2018
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Summary
This summary is machine-generated.

This study introduces a novel two-stage Phase II clinical trial design for new drugs. It aims to efficiently assess drug efficacy and determine optimal dosage through adaptive strategies, improving drug development timelines.

Keywords:
clinical trialdose rangingproof-of-concepttwo-stage design“Go/NoGo” decision

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Area of Science:

  • Clinical pharmacology
  • Drug development
  • Biostatistics

Background:

  • Phase II clinical trials are critical for establishing proof of concept (PoC) and dose ranging for new drug candidates.
  • Traditional Phase II trials often involve separate studies for PoC and dose ranging, potentially extending development timelines.
  • Current PoC studies typically compare a high dose against a placebo, followed by extensive dose-ranging studies if successful.

Purpose of the Study:

  • To propose and evaluate a novel two-stage Phase II clinical trial design.
  • To generate an early signal of drug efficacy in the first stage.
  • To efficiently explore the dose-efficacy relationship in the second stage based on early results.

Main Methods:

  • A two-stage adaptive design is proposed for Phase II clinical development.
  • Stage 1 focuses on obtaining an early efficacy signal using a high dose and placebo.
  • Stage 2 employs a 'Go Fast' strategy (expanding the study with lower doses) if Stage 1 is successful, or a 'Go Slow' strategy (stopping with reduced sample size) otherwise.

Main Results:

  • The proposed design allows for early assessment of efficacy.
  • Adaptive 'Go Fast' or 'Go Slow' strategies enable efficient resource allocation.
  • The design aims to optimize the balance between confirming efficacy and exploring the dose range.

Conclusions:

  • This two-stage design offers a more efficient approach to Phase II drug development.
  • It allows for timely decision-making regarding further drug investigation and dose selection.
  • The adaptive nature of the design can accelerate the identification of effective drug dosages.