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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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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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Clinical Trials01:16

Clinical Trials

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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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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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Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

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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...
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Drug Discovery: Overview01:26

Drug Discovery: Overview

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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...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Expanding access to early phase trials: the CATCH-UP.2020 experience.

Joaquina C Baranda1, Francisco J Diaz2, Larry Rubinstein3

  • 1Department of Medical Oncology, University of Kansas Cancer Center, Kansas City, KS, USA.

JNCI Cancer Spectrum
|December 16, 2022
PubMed
Summary
This summary is machine-generated.

The Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP.2020) initiative successfully accelerated early phase clinical trial activation and patient accrual. This program expanded access to novel cancer therapies for underserved populations, addressing critical disparities in cancer outcomes.

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Area of Science:

  • Clinical trial management
  • Cancer therapeutics
  • Health equity

Background:

  • Persistent disparities in cancer outcomes disproportionately affect underserved populations.
  • Limited access to early-phase clinical trials is a significant barrier for these groups.
  • The National Cancer Institute-funded Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP.2020) program was established to address these issues.

Purpose of the Study:

  • To report on the tools developed and accrual metrics from the initial year of the CATCH-UP.2020 program.
  • To focus on the engagement and enrollment of racial, ethnic, geographic, and socioeconomically underserved populations.
  • To evaluate the program's effectiveness in improving access to targeted cancer therapies.

Main Methods:

  • CATCH-UP.2020 is a supplement to P30 grants awarded to 8 National Cancer Institute-designated cancer centers.
  • Sites utilized a combination of patient-based, community-based, investigator-based, and program-based tools.
  • Emphasis was placed on rapidly opening and accruing patients to Experimental Therapeutics Clinical Trials Network (ETCTN) trials.

Main Results:

  • During the initial year (September 2020-August 2021), 45 ETCTN trials were opened by CATCH-UP.2020 sites.
  • The weighted average trial activation time was 107 days.
  • 145 patients were enrolled, with 68 (46.9%) from underserved populations (racial, ethnic, rural, socioeconomic).
  • Patients from racial and ethnic minority groups represented 15.8% of ETCTN network accruals and 21.4% of CATCH-UP site accruals.

Conclusions:

  • Targeted funding accelerated the activation and accrual of early-phase clinical trials.
  • The CATCH-UP.2020 program successfully expanded access to therapeutic options for underserved populations.
  • The initiative demonstrated a positive impact on cancer care equity.