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Placebo: Why and why not?

Placebo: Why and why not?. Group Four Mariam Ahmed, Irine Jepchirchir, Dylan Galos, Lucie Turcotte, Chris Campbell, Junghi Kim, and Brett Peterson. Placebo. An inactive agent, used in the study control arm, to maintain blinding in a clinical trial

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Placebo: Why and why not?

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  1. Placebo: Why and why not? Group Four Mariam Ahmed, Irine Jepchirchir, Dylan Galos, Lucie Turcotte, Chris Campbell, Junghi Kim, and Brett Peterson

  2. Placebo • An inactive agent, used in the study control arm, to maintain blinding in a clinical trial • Controls for changes in the course of disease and for suggestion (“placebo effect”) • Can be used as a single agent or as an “add-on” to optimal medical management to facilitate blinding

  3. Consider Placebo If: • Limited knowledge of long-term or short-term effects of available therapy • Significant toxicity associated with available or standard therapy • Limited availability of current therapy in certain settings • External data is not clear and considering an active control trial

  4. Ellenberg and Temple. Ann Intern Med; 133;464-470.

  5. Therapeutic advances Ellenberg, S.S., & Temple, R. Ann Intern Med, 2000; 133;464-470

  6. Ethical Considerations • Seriousness of illness • Does withholding treatment increase risk of significant morbidity or decrease survival? • Allergic rhinitis vs. cancer • Informed consent • Does the patient understand the possibility of not receiving active therapy? • If alternative therapies are available, is the patient aware of them and consequences of delaying treatment?

  7. Declaration of Helsinki • Article II.3 of the declaration of Helsinki: “in any medical study, every patient—including those of a control group, if any—should be assured of the best proven diagnostic and therapeutic methods”

  8. Active Control Trials • Comparing a standard therapy to a test therapy • In order to establish treatment efficacy, one must: • Prove superiority of test over standard, OR • Show equivalence or non-inferiority to known effective therapy • Require information external to the trial • Past placebo-controlled studies proving superiority of standard over placebo Temple and Ellenberg. Ann Int Med 2000.

  9. Consider Active Control If: • Assay sensitivity can be assumed • Doing a later phase trial where superiority over standard therapy (relative effectiveness) is question of interest • Placebo is not ethically acceptable

  10. Example Ann Intern Med. 2000;133:455-463.

  11. Conclusions • Certain situations absolutely preclude use of placebo when effective therapy is available • Less clarity for non-life threatening conditions • Considerations must be given to: • Limitations to existing effective therapy • Importance of blinding • Potential use of optimal medical management • Ability to successfully carry out active control trial • Ultimately trial designers decide

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