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Updated: Apr 7, 2026

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
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Early phase cancer clinical trials: design, ethics and future directions

Nicholas Coupe1, Avinash Gupta2, Simon R Lord3

  • 1Clinical Research Fellow in Medical Oncology.

British Journal of Hospital Medicine (London, England : 2005)
|July 4, 2015
PubMed

Insights

Early phase cancer trials determine optimal drug dosage. Study designs are evolving to focus on molecularly targeted agents in cancer drug development.

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Drug Development

Background:

  • Early phase clinical trials are crucial for establishing the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) for novel cancer therapeutics.
  • Traditional dose-escalation designs are well-established but may not be optimal for all new drug classes.

Purpose of the Study:

  • To describe the evolving role of early phase clinical trials in cancer research.
  • To highlight the impact of molecularly targeted agents on trial design.

Main Methods:

  • Review of current early phase clinical trial designs.
  • Analysis of how drug development trends influence study methodologies.
  • Discussion of adaptive and novel trial designs.

Main Results:

  • The primary objective of dose determination remains central to early phase trials.
  • A shift towards incorporating molecular profiling and targeted therapies necessitates design modifications.
  • Newer designs aim for greater efficiency and earlier assessment of efficacy signals.

Conclusions:

  • Early phase cancer trial designs are adapting to the era of precision medicine.
  • Future trials will increasingly integrate molecularly targeted agents and potentially novel designs to optimize drug development pathways.

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