The ethics of clinical trials

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This is a lecture on ethical issues related to clinical trials. It is for Module 4 of an online Medical Ethics course I am teaching at BGSU.

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The ethics of clinical trials

  1. 1. The Ethics of Clinical Trials<br />Medical Ethics Online<br />Summer 2011<br />Eli Weber-Instructor<br />
  2. 2. Lecture Goals<br />Explain the structure and organization of clinical trials<br />Highlight the ethical dilemma that clinical trials create for physicians<br />Outline the “standard” respond to this dilemma<br />Consider some further ethical issues associated with clinical trials<br />
  3. 3. What is a Clinical Trial?<br />A clinical trial is a research study designed to test the effectiveness and side effects of a treatment for human subjects.<br />4 Phases<br />-Phase 1-tests for toxicity only<br />-Phase 2-tests efficacy, further evaluates toxicity<br />-Phase 3-confirmation of efficacy in larger group<br />-Phase 4-fine tuning<br />
  4. 4. Why Clinical Trials?<br />Limits of animal experimentation<br />More reliable than other sources of evidence<br />-Isolates relevant variable<br />Control groups<br />Randomization<br />Blindness<br />
  5. 5. Ethical Issues with Clinical Trials<br />Embarrassing History<br />Treats patients in the control group as a means to an end.<br />-Conflict between physicians’ duty of beneficence and randomization<br />If physicians have a duty to recommend the treatment that they believe to be best, suggesting a clinical trial for a patient is rarely consist with this duty, because there is nearly always a better option for the patient.<br />
  6. 6. Ethical Issues with Clinical Trials<br />-Placebos vs. Active-control studies<br />A placebo study is never acceptable when there is an available treatment that is known to be effective.<br />Active-control studies involve comparing promising new treatments against treatments regarded as inadequate.<br />Standard worries with informed consent<br />-ability to understand relevant information<br />-vulnerable populations<br />-coercion<br />
  7. 7. Typical Reply to Ethical Objections<br />There is no ethical conflict between a physicians’ duty of beneficence and offering the patient the option of participating in a clinical trial, provided certain conditions are met:<br />Genuine clinical equipoise exists<br />Physician explains that their recommendation is based on evidence that isn’t the “gold standard.”<br />-This is a component of informed consent<br />-Marquis: physicians have a duty to offer clinical trials in these cases<br />*Also addresses concerns about active-control studies.<br />
  8. 8. Typical Replies to Ethical Objections<br />If patients give informed consent, it is acceptable to use them as a means.<br />In general, these issues are dealt with by appeals to informed consent and restrictions on when clinical trials are acceptable. The medical community defends a moderate view about the ethics of clinical trials.<br />
  9. 9. Further Issues with Clinical Trials<br />How do we assess clinical equipoise? How much equipoise is enough?<br />-PLX4032 Clinical trial<br />Balancing the need for information about long-term effectiveness against the fact of immediate need.<br />-Is it ethical to continue a study in the face of compelling evidence of efficacy, for the sake of assessing long-term effects?<br />
  10. 10. Further Issues with Clinical Trials<br />Should pharmaceutical companies be allowed to hold a promising new drug off the market for the sake of obtaining further evidence of its efficacy?<br />Can physicians fulfill their alleged duty to offer clinical trials without inadvertently coercing participation?<br />
  11. 11. The Bottom Line<br />Clinical trials appear to be a necessary component of medical research.<br />The ethical issues associated with clinical trials are numerous, and often involve patient autonomy and well-being juxtaposed with the duties of physicians and benefits to future generations (in addition to the standard worries about informed consent).<br />It’s not clear that informed consent is the “magic” solution to ethical issues related to clinical trials.<br />

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