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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Preclinical Development: Overview01:28

Preclinical Development: Overview

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...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Drug Discovery: Overview01:26

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

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Related Experiment Video

Updated: Jul 17, 2026

Preclinical Assessment of the Bioactivity of the Anticancer Coumarin OT48 by Spheroids, Colony Formation Assays, and Zebrafish Xenografts
09:20

Preclinical Assessment of the Bioactivity of the Anticancer Coumarin OT48 by Spheroids, Colony Formation Assays, and Zebrafish Xenografts

Published on: June 26, 2018

Compressing drug development timelines in oncology using phase '0' trials.

Shivaani Kummar1, Robert Kinders, Larry Rubinstein

  • 1Center for Cancer Research, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland, USA.

Nature Reviews. Cancer
|January 26, 2007
PubMed
Summary

Phase 0 trials integrate pharmacodynamic assays into early cancer drug development. These trials assess assay feasibility, biomarkers, and pharmacokinetics, potentially accelerating anticancer drug discovery.

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Related Experiment Videos

Last Updated: Jul 17, 2026

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Evaluating molecularly targeted anticancer agents needs pharmacodynamic assays in early clinical studies.
  • Current early-phase trials may not fully leverage pharmacodynamic data.

Purpose of the Study:

  • To explore the utility of Phase 0 trials in optimizing the evaluation of novel anticancer agents.
  • To establish Phase 0 trials as a platform for assay feasibility and biomarker assessment.

Main Methods:

  • Utilizing the US Food and Drug Administration's Exploratory Investigational New Drug Guidance.
  • Integrating pharmacodynamic assays and pharmacokinetic data collection within Phase 0 trials.
  • Assessing target modulation and drug effects in human samples.

Main Results:

  • Phase 0 trials can establish the feasibility of pharmacodynamic assays in human samples.
  • These trials provide valuable pharmacokinetic data and biomarker information.
  • Early identification of therapeutic failures and rational drug selection are facilitated.

Conclusions:

  • Phase 0 trials offer a valuable platform for early assessment of molecularly targeted anticancer agents.
  • Integrating these trials can potentially compress anticancer drug development timelines.
  • Phase 0 trials are expected to become a standard in early-phase oncology research.