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Early-phase development of cancer prevention agents: challenges and opportunities

Marjorie Perloff1, Vernon E Steele

  • 1Division of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd. EPN 2112, Rockville, MD 20892, USA. perloffm@mail.nih.gov

Cancer Prevention Research (Philadelphia, Pa.)
|March 8, 2013
PubMed

Insights

Cancer chemoprevention agents aim to reduce cancer risk. The National Cancer Institute

Area of Science:

  • Oncology
  • Preventive Medicine
  • Drug Development

Background:

  • Chemoprevention involves using agents to lower cancer incidence or recurrence.
  • The National Cancer Institute's Division of Cancer Prevention (NCI, DCP) is a key funder of cancer prevention research.
  • Developing cancer preventive agents faces distinct challenges compared to therapeutic drugs.

Purpose of the Study:

  • To outline the NCI, DCP's comprehensive drug development program for cancer preventive agents.
  • To discuss novel approaches and programs implemented by NCI, DCP to address challenges in clinical development.
  • To highlight the PREVENT Cancer Program and the Clinical Trials Consortium for advancing cancer prevention agents.

Main Methods:

  • Implementation of phase 0 clinical trial designs and microdose studies.
  • Establishment of the PREVENT Cancer Program for a structured decision-making process.
  • Formation of a Clinical Trials Consortium to facilitate agent development.

Main Results:

  • NCI, DCP has a structured program for cancer preventive drug development.
  • New strategies like phase 0 trials and microdosing are employed.
  • Formalized programs (PREVENT Cancer Program, Clinical Trials Consortium) streamline drug advancement.

Conclusions:

  • NCI, DCP employs innovative strategies to advance cancer chemoprevention.
  • The implemented programs provide a structured pathway for drug development and clinical trials.
  • These approaches aim to accelerate the availability of effective cancer preventive agents.

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