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Ethics and clinical trials.

O Chassany1, M Duracinský

  • 1Department of Internal Medicine, Hôpital Lariboisière, Paris, France.

Fundamental & Clinical Pharmacology
|August 24, 1999
PubMed
Summary
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This study outlines ethical guidelines for clinical trials, emphasizing patient consent and risk assessment. It details appropriate placebo use, stressing ethical considerations for vulnerable populations and severe diseases.

Area of Science:

  • Medical Ethics
  • Clinical Trial Design

Background:

  • The Declaration of Helsinki provides foundational ethical principles for human rights in medical research.
  • Key ethical tenets include patient autonomy, acceptable risk-benefit ratios, and protection of vulnerable subjects.

Observation:

  • Informed consent is paramount, requiring investigators to fully inform patients before trial participation.
  • New drugs should ideally be compared against placebos to demonstrate superiority; small trials against reference drugs risk inconclusive results.
  • Placebo effects can be significant (≥30%), influencing trial outcomes across various diseases.

Findings:

  • Placebo use is unethical in life-threatening conditions or when effective treatments exist.
  • Placebo administration is ethically permissible in severe diseases lacking effective drugs, and in some cases with existing treatments.

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  • Placebos are ethically acceptable for moderate and functional diseases.

    • Implications:

    • Journals increasingly require checklists to ensure the quality and ethical conduct of randomized clinical trials.
    • Physicians retain ultimate responsibility for ethical protocol evaluation, participation decisions, and patient enrollment.