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Clinical Research Question of the Month: October 2017

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 question:

You are a member of an IRB reviewing a study protocol for a new artificial heart that, if approved by the FDA, will likely save many lives. The study sponsor, a very small company, plans to test the device in patients who will probably die without the device. It cannot afford to test the device with an adequate sample size, so it proposes to increase the sample size with funds raised by auctioning off the right to participate. Any delay in approval will likely cost lives.

You have no other information to make your decision and no clever way to dodge it. How will you vote? Read the full question and give us your answer.

 

Last month’s question posed a dilemma about reporting an SAE in your struggling clinical research site. All respondents said they would report the problem, but responses about who they would tell varied somewhat. Nearly 75% said they would tell the the study sponsor, 67% would tell the IRB, 42% would tell the FDA, and 33% would tell someone in authority at the CRO. For more data and analysis of the problem, see the report.

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!

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