Friday, March 20, 2009

More suicidal monitoring needed in clinical trials?

In a recent post by Dr. Michael McKelvey, he addresses the issue of suicide monitoring in clinical trials. He states that the number seeking regulatory approval is increasing. And the FDA has recently issued guidelines for the topic. However, there needs to be a fully structured, procedurally reliable and replicated process for monitoring suicidality. What do you think? Is this an issue for your clinical trials?

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