The Association of Clinical Research Professionals

Why Do Surgical Placebo Controlled Trials?

In this session, the rationale for surgical placebo-controlled trials will be reviewed. One example of such a trial is the world first randomized placebo-controlled trial to evaluate the efficacy and cost-effectiveness of decompressive surgery for lumbar spinal stenosis, which is currently being conducted in Australia. A variety of techniques have been used to address ethical and safety considerations including the unusual step of recruiting a consumer and ethicist to act in advisory roles to provide input on the practicalities of the study design. This session will provide attendees with a high level overview of the trial together with highlighting key learnings about protocol design, consent form drafting and collection of consent, recruitment of surgeons, working with private healthcare providers, and other relevant site level activities.

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This program is a session from ACRP 2019