Clinical Research Question of the Month: July 2018

In collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and highlight discussion generated by the prior month’s question.

This month’s scenario:

You are a member of an IRB that is reviewing a study on the effectiveness of placebo “treatments.” It is well known that different sizes, shapes and colors of pills cause different levels of the placebo effect, which also varies by the therapeutic indication and the country/culture. The investigators want to test the placebo effect across a broad range of diseases and countries. The placebo pill will be presented as a “booster” to their current treatment—not a placebo. 

Will you vote to approve this study? How much does it concern you that the participants will be deceived into thinking that the pill is a real drug? To answer this question and others, take the survey here.

The last question posed readers with a hypothetical situation in which a diagnostic study was proposed to detect which patients infected with a new virus would develop dementia. The experimental test is believed to be 100% accurate in identifying who would get dementia, but has the unique “quantum” effect of flipping the medical condition of the person tested. Seventy-two percent of survey respondents replied that they would not vote to approve the study. The full report further delves into the complex issues of acceptable levels of risk and the rights of an individual patient when there is possible benefit to many. You can read the full report here.

The Question of the Month also appears on the IRB Forum. The IRB Forum is a robust community of IRB professionals engaged in an ongoing discussion of the latest issues and questions that arise for human subjects protections professionals. An account is free, and gives you access to an invaluable resource—the insight of your peers.

PRIM&R thanks Norm Goldfarb of First Clinical Research for allowing us to share this feature with our community!