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Evolving Concepts in Phases I and II Drug Development for Crohn's Disease

Vipul Jairath1,2,3, Barrett G Levesque2,4, Niels Vande Casteele2,4,5

  • 1Department of Medicine, University of Western Ontario, London, ON, Canada.

Journal of Crohn'S & Colitis
|August 5, 2016
PubMed

Insights

Improving early drug development for Crohn's disease is crucial. This review proposes strategies to accelerate promising treatments and stop ineffective ones at the proof of concept stage.

Area of Science:

  • Gastroenterology
  • Clinical Pharmacology
  • Drug Development

Background:

  • High attrition rates in drug development programs, particularly at the proof of concept stage, necessitate improved efficiency.
  • Numerous drug candidates for Crohn's disease (CD) underscore the need for better early-stage evaluation.
  • Current methods often fail to efficiently identify effective CD therapies.

Purpose of the Study:

  • To review strategies for enhancing early drug development in Crohn's disease.
  • To propose an integrated paradigm for more efficient proof of concept studies.
  • To accelerate the identification of promising Crohn's disease treatments.

Main Methods:

  • Review of existing and novel strategies for early drug development.
  • Analysis of responsive outcome measures in clinical trials.
  • Incorporation of pharmacokinetic (PK) and pharmacodynamic (PD) modeling.
  • Exploration of novel clinical trial designs and exposure-based dosing.

Main Results:

  • Responsive outcome measures can improve trial efficiency.
  • PK/PD modeling and biomarkers enhance understanding of drug exposure and effect.
  • Novel trial designs can optimize the evaluation of new therapies.
  • An integrated approach can significantly improve early drug development success rates.

Conclusions:

  • Implementing advanced outcome measures and PK/PD strategies is vital.
  • Novel trial designs are essential for efficient drug evaluation in Crohn's disease.
  • An integrated paradigm offers a pathway to accelerate the development of effective Crohn's disease therapies.
Keywords:
Crohn’s diseaseclinical trials

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