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Related Concept Videos

Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Clinical Trials: Overview01:11

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Development and Maintenance of a Preclinical Patient Derived Tumor Xenograft Model for the Investigation of Novel Anti-Cancer Therapies
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Academic Cancer Center Phase I Program Development.

Arthur E Frankel1, Keith T Flaherty2, George J Weiner3

  • 1University of Texas Southwestern Medical Center, Dallas, Texas, USA arthur.frankel@utsouthwestern.edu.

The Oncologist
|March 19, 2017
PubMed
Summary
This summary is machine-generated.

Key factors for successful academic phase I cancer programs include strong philanthropic support, experienced staff, and efficient administration. Mature programs benefit from integration into disease-oriented teams for optimal patient care and research.

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Area of Science:

  • Oncology
  • Clinical Research
  • Health Services Research

Background:

  • Academic phase I cancer programs are crucial for early-stage cancer drug development.
  • Identifying critical success factors is essential for optimizing program effectiveness and patient outcomes.
  • Previous research has not comprehensively evaluated the multifaceted elements contributing to phase I program success.

Purpose of the Study:

  • To identify and assess the key factors contributing to the effectiveness of academic phase I cancer programs in the U.S.
  • To provide a framework for establishing and improving new and existing phase I programs.

Main Methods:

  • A cross-sectional assessment of 16 academic cancer centers in the U.S.
  • Data collection likely involved surveys, interviews, or analysis of program structures and outcomes.
  • Success metrics included clinical trial portfolio breadth, investigator-initiated studies, correlative science, and patient base size.

Main Results:

  • Successful programs feature broad phase I/II clinical trial portfolios, investigator-initiated studies, and correlative science.
  • Critical elements include philanthropic support, experienced research managers, robust basic research, streamlined administration, patient navigators, and a large patient base.
  • New programs may thrive as stand-alone operations, while mature programs integrate into disease-oriented teams.

Conclusions:

  • Institutional support, experienced personnel, efficient administration, and patient engagement are vital for academic phase I cancer program success.
  • Program structure (stand-alone vs. integrated) should adapt based on program maturity.
  • The identified metrics can serve as a valuable rubric for evaluating and enhancing phase I programs.