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Clinical trials

M Blichert-Toft1, H Mouridsen, K W Andersen

  • 1Danish Breast Cancer Cooperative Group, Rigshopitalet, Copenhagen, Denmark.

Seminars in Surgical Oncology
|January 1, 1996
PubMed
Summary
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Randomized clinical trials protect patients but face low enrollment due to informed consent challenges. Explaining randomization to patients significantly impacts participation rates in crucial cancer research.

Area of Science:

  • Clinical Research
  • Oncology
  • Medical Ethics

Background:

  • Randomized clinical trials (RCTs) are essential for evaluating new treatments, particularly in cancer care.
  • A significant gap exists between eligible patients and those enrolled in RCTs.

Purpose of the Study:

  • To investigate the discrepancy in patient enrollment in randomized trials.
  • To identify factors contributing to patient refusal to participate in clinical studies.

Main Methods:

  • Analysis of factors influencing patient enrollment in randomized clinical trials.
  • Examination of the impact of informed consent procedures on participation.

Main Results:

  • Informed consent requirements are a primary reason for patient non-participation in RCTs.
Keywords:
Biomedical and Behavioral Research

Related Experiment Videos

  • Disclosure of randomization as a treatment allocation method can lead to patient refusal rates as high as 50% or more.
  • Physicians may feel conflicted when explaining randomization, impacting their supportive role.

    • Conclusions:

    • The process of obtaining informed consent for RCTs, especially regarding randomization, presents a significant barrier to patient enrollment.
    • Addressing physician concerns and patient understanding of randomization is crucial to improve participation in vital clinical research.