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Design of phase I and II clinical trials in oncology and ethical issues involved

B C Goh1

  • 1Department of Medical Oncology, National University Hospital, 5 Lower Kent Ridge Road, Singapore 119074. gohbc@nuh.com.sg

Annals of the Academy of Medicine, Singapore
|December 29, 2000
PubMed
Abstract

Insights

Developing novel anticancer drugs targeting signal transduction and antiangiogenesis presents challenges. These newer agents require different clinical trial strategies compared to traditional cytotoxic chemotherapy drugs.

Area of Science:

  • Oncology Drug Development
  • Clinical Trial Design

Background:

  • Anticancer drugs fall into two main classes: classical cytotoxic agents and newer agents targeting signal transduction or antiangiogenesis.
  • Classical cytotoxic agents have low therapeutic indices, necessitating distinct developmental strategies compared to non-oncology drugs.
  • Newer targeted anticancer agents share characteristics with non-oncology drugs, potentially altering oncology drug development paradigms.

Purpose of the Study:

  • To review the challenges and issues inherent in phase I and II cancer clinical trials.
  • To outline how these identified issues have been addressed in the context of anticancer drug development.

Main Methods:

  • Literature review of phase I and II cancer trials.
  • Analysis of developmental strategies for cytotoxic versus targeted anticancer agents.

Main Results:

  • Phase I and II cancer trials face significant scientific and ethical considerations that impact study design.
  • Novel anticancer agents targeting signal transduction and antiangiogenesis present unique developmental challenges.
  • The conventional cytotoxic drug development model is expected to evolve for these newer agents.

Conclusions:

  • Despite challenges, phase I and II clinical trials are crucial for advancing anticancer agent development.
  • The development of targeted therapies necessitates a shift from traditional cytotoxic drug development approaches.
  • Future oncology drug development will likely see changes in trial design to accommodate novel therapeutic strategies.

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