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Stopping trials early for commercial reasons: the risk-benefit relationship as a moral compass

A S Iltis1

  • 1Center for Health Care Ethics, Saint Louis University, 221 N. Grand Blvd, Saint Louis, MO 63103, USA. iltisas@slu.edu

Journal of Medical Ethics
|July 5, 2005
PubMed

Insights

Industry sponsors ending clinical trials early for profit is controversial. Early termination is unethical if risks outweigh benefits and crucial data is still obtainable, altering the fundamental risk-benefit balance.

Area of Science:

  • Clinical Research Ethics
  • Medical Trial Oversight
  • Biomedical Research Governance

Background:

  • Industry-sponsored clinical trials are frequently terminated early.
  • These early terminations, often for commercial reasons, raise ethical concerns regarding participant safety and scientific integrity.

Purpose of the Study:

  • To evaluate the ethical implications of early clinical trial termination by industry sponsors.
  • To establish the primary ethical consideration for assessing such decisions.

Main Methods:

  • This study presents a philosophical argument.
  • It analyzes the concept of the risk-benefit relationship in human research ethics.

Main Results:

  • Early termination is ethically impermissible if the potential scientific benefits do not justify the risks already borne by participants.
  • Such termination constitutes an unethical alteration of the established risk-benefit relationship.

Conclusions:

  • The risk-benefit relationship is the principal ethical consideration when assessing early trial terminations.
  • Unethical alterations to this relationship violate the foundational principles of human research, informed consent, and investigator agreement.
Keywords:
Analytical ApproachBiomedical and Behavioral Research

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