Suicidal Ideation and Behavior: We Can Make a Difference - By Jean Paty

Description

Applied Clinical Trials, September 2013 - In this 'Closing Thought' article, Dr. Jean Paty provides his perspective on the FDA's Draft Guidance to Industry on Suicidal Ideation and Behavior (SIB): Prospective Assessment of Occurrence in Clinical Trials (2010/2012) and the opportunity it presents for the biopharmaceutical industry to make a difference in identifying those at risk of suicide.

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Assessing Suicide Risk

Description

European Pharmaceutical Contractor, December 2012 - The US FDA regulatory Guidance on Suicidal Ideation and Behaviour has been reviewed and re-released as study teams are concerned with patient safety, regulatory compliance and reducing site burden. This article provides an overview of the revised FDA draft guidance, the limitations of the C-SSRS and the benefits of the eC-SSRS in meeting this FDA requirement.

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Prospective Assessment Of Suicidal Ideation and Behavior (SIB) In Clinical Trials - By Michael Federico

Description

Life Science Leader, December 2012 - The U.S. FDA has revised its Guidance on Prospective Assessment of Suicidal Ideation and Behavior (SIB), suggesting that in addition to being required for psychiatric trials, it also applies to depression, smoking cessation, weight loss, and other studies of drugs that appear to have a CNS effect. This article reviews how researchers can meet the FDA's expectations in capturing this important assessment, regardless of the therapeutic area being studied.

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Capturing Suicidal Patient Data - By Mike Federico

Description

Applied Clinical Trials, November 2012 - This article will review the FDA's current recommendations on SIB assessment in clinical development, and offer insight as to how the electronic collection of this important data can help trial sponsors meet current regulatory requirements.

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Centralized ECGs Help Ensure Cardiac Safety of Obesity Drugs" Dr. Robert Kleiman

Description

International Pharmaceutical Industry, September 2012 - The author reviews the regulatory requirements biopharmaceutical organizations must meet for demonstrating cardiac safety during the clinical development of new obesity drugs, and presents the benefits of using centralized ECG data collection over the traditional, de-centralized approach.

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