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Related Concept Videos

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.
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Ethical principles are essential in guiding nurses to fulfill their responsibilities, focusing on the quality of nursing care and decision-making. These principles, including autonomy, beneficence, non-maleficence, justice, and fidelity, shape the ethical framework within healthcare settings.
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Related Experiment Video

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Time Burdens for Participants With Advanced Cancer in Phase I Trials: A Cross-Sectional Study.

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  • 1McGill University, Montreal, Quebec, Canada.

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|October 1, 2024
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Participating in phase I cancer trials requires significant time commitment, with patients dedicating 15% of trial days to planned research visits, particularly in the first month. This highlights the substantial contribution of time by participants in early-phase cancer drug development.

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Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Biostatistics

Background:

  • Phase I cancer clinical trials are crucial for early drug development.
  • Participation often involves extensive patient time for visits and procedures.
  • Quantifying this time commitment is essential for understanding participant burden.

Purpose of the Study:

  • To quantify the planned time commitment and number of procedures for participants in phase I cancer clinical trials.
  • To provide an estimate of the patient time investment in early-phase cancer drug development.

Main Methods:

  • Searched ClinicalTrials.gov for phase I cancer trials (2020-2022) with available assessment schedules and results.
  • Included trials for participants with advanced or metastatic disease.
  • Measured planned research days (PRDs) per participant up to the first month and for the entire trial duration.
  • Estimated the number of research procedures per participant.

Main Results:

  • Analyzed 71 phase I trials with 3,904 participants; median participation was 2.5 months.
  • Median PRDs per participant were 7 in the first month and 4.5 per month overall.
  • Participants spent 15% of trial days on planned research activities.
  • Common procedures included physical exams (8), infusions (6), ECGs (6), and biopsies (1).

Conclusions:

  • Phase I cancer trial participation demands substantial participant time, especially during the initial month.
  • Planned research activities account for 15% of a participant's trial days.
  • These findings represent a lower bound of time commitment, excluding unplanned visits.