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[Informed consent in phase I trial]

Y Shimada1

  • 1Department of Medical Oncology, National Cancer Center Hospital, Japan.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|January 1, 1996
PubMed
Summary
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Informed consent for phase I trials requires full disclosure of trial details, including purpose, procedures, and risks, for cancer patients. This process ensures ethical participation in early drug development, resembling a collaborative discussion before treatment.

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Bioethics

Context:

  • Phase I trials represent the initial human testing phase for novel drug candidates.
  • These trials are crucial for assessing the safety and determining optimal dosing of new cancer therapies.
  • Ethical considerations are paramount due to the experimental nature and potential risks involved.

Purpose:

  • To elucidate the essential components of informed consent in phase I clinical trials.
  • To highlight the unique challenges and ethical imperatives in obtaining consent for early-phase cancer drug studies.
  • To emphasize the necessity of comprehensive disclosure regarding trial objectives, procedures, and risk-benefit profiles.

Summary:

  • Informed consent in phase I trials necessitates thorough disclosure of the trial's purpose, procedures, and associated risks and benefits.

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  • Patients must be fully informed about their cancer diagnosis and disease extent prior to enrollment.
  • The informed consent process should be viewed as a collaborative discussion, not a legalistic contract, between patient and physician.

    • Impact:

    • Enhances ethical conduct in early-phase cancer research.
    • Promotes patient autonomy and understanding in experimental cancer treatment.
    • Contributes to the responsible advancement of new drug development through transparent patient engagement.