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Molecular prescreening to select patient population in early clinical trials

Jordi Rodón1, Cristina Saura, Rodrigo Dienstmann

  • 1Medical Oncology Department, Vall d'Hebrón University Hospital, Spain. jrodon@vhio.net

Nature Reviews. Clinical Oncology
|April 5, 2012
PubMed

Insights

Biomarker-driven clinical trials are the future of cancer treatment, focusing on targeted therapies. This approach optimizes early drug development by testing safety, dosage, and patient selection in phase I trials.

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Translational Medicine

Background:

  • The paradigm of cancer treatment is shifting towards targeted therapies, necessitating patient selection based on molecular tumor characteristics.
  • Biomarker-driven clinical trials are crucial for evaluating the efficacy and safety of these novel therapeutics.

Approach:

  • This perspective outlines strategies for establishing pre-screening programs within academic institutions to support early-phase drug development.
  • It details the integration of these programs into ongoing clinical trials, using the Vall d'Hebrón phase I program as a case study.

Key Points:

  • Phase I trials are essential for early hypothesis testing, assessing safety, toxicity, target engagement, and optimal biological effective doses.
  • Identifying the appropriate patient population is a critical component of biomarker-driven trial design.
  • Academic institutions play a vital role in building the infrastructure for early drug development and biomarker discovery.

Conclusions:

  • Implementing robust pre-screening programs in academic settings can facilitate biomarker-driven clinical trials.
  • This approach enhances the efficiency of early drug development and supports the personalized medicine revolution in oncology.
  • The insights provided aim to guide other institutions in establishing similar early drug development programs.

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