New Clinical Insight: The Pathologist’s Role in the Diagnosis and Management of Disease
Posted by Kathy MurrayMarch 31, 2010, 2:33 AM
Our latest Clinical Insight is a must read for anyone conducting clinical trials that analyze pathology tissue. Written in partnership with Dr. Xiaolan Ou, Dr. John D’Souza and myself,we discuss how tissue specimens are an essential component for the diagnosis and assessment response to treatment, especially in oncology studies.
 
Studies involving tissue pathology require accurate and standardized interpretations of specimens from similar areas, and are essential for the assessment of primary end points prior to submission of the test product for approval to the FDA. In this issue, we discuss: 
  • 3 key elements for a successful study involving pathology tissue
  • The precise measures that must be conducted when using several different interpretations from many pathologist in a single study
  • An informative illustration on the pathologist’s role in the diagnosis and management of breast cancer
We would certainly like to hear from you about your experiences of how pathologists have helped diagnose subjects for valid inclusion in a trial.
 
For those unfamiliar with our Clinical Insights, we produce a series of technical reports written by our team of experts on issues effecting clinical testing today. These insights provide detailed information concerning current methodology, specimen requirements, and reference ranges on new and specialized tests. Based on our knowledge and experience with safety and specialty testing, we provide our opinions on the clinical significance of specific tests and how they can impact your clinical trial.
 
Thanks for tuning in. You can download the entire article here or browse our previous issues for more central lab services insights. We also encourage you to subscribe to our Clinical Insights to receive them directly in your inbox.
 
We look forward to your comments!
Category: Clinical Trials Testing
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