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Key Stakeholders to Discuss Regulatory Issues Related to the Use of Study Endpoints in Multinational Clinical Trials
Date:9/2/2009

The Drug Information Association (DIA) Study Endpoints Special Interest Area Community (SIAC) will host Measuring Study Endpoints in Multinational Clinical Trials: Outcomes Reported from the Viewpoint of the Clinician, Patient, and Caregiver from October 26-27, 2009 in New Orleans, LA.

Horsham, PA (Vocus) September 2, 2009 --The Drug Information Association (DIA) Study Endpoints Special Interest Area Community (SIAC) will host Measuring Study Endpoints in Multinational Clinical Trials: Outcomes Reported from the Viewpoint of the Clinician, Patient, and Caregiver from October 26-27, 2009 in New Orleans, LA.

Representatives from industry, FDA, and EMEA will convene to discuss the scientific and regulatory issues surrounding the use of study endpoints in support of medical product labeling claims. Sessions will discuss common principles for the development and validation of all study endpoint measures and the relationships between entry criteria and outcome measurement and between different types of endpoint measures. Specific sessions include:

 
  • Defining Terms and Setting the Regulatory Context
  • Models, Measures and Claims  &
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