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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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When toxic substances penetrate the human body, they disseminate to various tissues, undergoing metabolic changes. This process yields reactive metabolites that may covalently bind with specific target molecules, resulting in toxicity.
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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.
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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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Updated: Jun 24, 2025

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Time Toxicity Experienced by Early-Phase Cancer Clinical Trial Participants.

Sienna M Durbin1, Debra M Lundquist2, Andrea Pelletier3

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Patients in early-phase clinical trials (EP-CTs) spend over 20% of their time on health care visits, a metric known as time toxicity. Higher time toxicity in EP-CTs is linked to poorer cancer treatment outcomes.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Health Services Research

Background:

  • Early-phase clinical trials (EP-CTs) are crucial for developing novel cancer therapeutics.
  • The extent of patient engagement with the healthcare system, termed 'time toxicity,' during EP-CTs is not well understood.

Purpose of the Study:

  • To quantify time toxicity in patients undergoing EP-CTs.
  • To identify predictors of increased time toxicity.
  • To evaluate the association between time toxicity and clinical outcomes in cancer patients.

Main Methods:

  • Retrospective review of electronic health records for 408 patients in EP-CTs (2017-2019).
  • Calculation of health care-associated days as a proportion of total days on trial.
  • Univariable and multivariable analyses to identify predictors and regression models to assess associations with outcomes.

Main Results:

  • Patients experienced an average of 22.5% health care-associated days during EP-CTs.
  • Higher time toxicity was associated with specific cancer types (GI, head/neck, breast), worse performance status, and targeted therapies.
  • High time toxicity correlated with reduced disease response rates, progression-free survival, and overall survival.

Conclusions:

  • Patients in EP-CTs dedicate a significant portion of their trial time to health care interactions.
  • Predictors of time toxicity were identified, highlighting patient and treatment characteristics.
  • High time toxicity is a significant factor associated with worse clinical outcomes in cancer patients on EP-CTs, informing patient counseling and trial design.