SOURCE: Xtalks

Xtalks Webinars

October 27, 2015 07:30 ET

Upcoming Webinar to Provide An Overview and Guide to Clinical Trial Endpoint Adjudication

TORONTO, ON--(Marketwired - October 27, 2015) - On Monday, November 9, 2015, Xtalks will host a complimentary webinar providing an overview of the independent endpoint adjudication process with a focus on understanding what is necessary to operationalize an endpoint committee. Featured speakers include Dr. Richard Walovitch, President of WorldCare Clinical, and Dr. Glenn Bubley, Director of Genitourinary Medical Oncology at Beth Israel Deaconess Medical Center.

Over the last few years the majority of drugs approved by the FDA have been approved based on results obtained using independent adjudication committees. The data from these committees are often used to determine primary safety and efficacy endpoints and are of paramount importance to drug and device approvability. Yet little regulatory guidance is provided regarding how these committees should be designed and performed.

Besides being a mechanism to remove bias, by using integrated teams of sub-specialty trained clinical experts, independent adjudication committees may also increase the accuracy and precision of any subjective assessment. In addition, a central adjudication can provide a solution to the variability in endpoint definition based on standard of care caused by trials becoming more global and of longer duration.

During this session you will:

  • Learn to determine what data needs independent adjudication and what type of adjudication paradigm fits what type of data
  • Be introduced to the limited guidance that exists regarding endpoint adjudication and how to develop the critical regulatory document, the "Endpoint Charter"
  • Become familiar with the technological considerations for developing a cost effective and fully digital endpoint adjudication process
  • Be provided with a clinical perspective on the differences between clinical assessments made in the practice of medicine versus independent assessments utilizing selective clinical trial data
  • Learn how to develop an on-study training and testing program for your adjudicators to maximize accuracy and precision of their assessments
  • See case histories utilizing different adjudication paradigms and processes

If you are designing trials with subjective endpoints this webinar may benefit your design. Whether you are from a biotech, pharmaceutical, or medical device company with responsibility or involvement in Clinical Operations, Project Management, Medical Affairs, Pharmacovigilance, Protocol Development, Biostatistics, or Data Management, you will come away with tools that can bring your trials greater accuracy and precision.

For more information or to register for this free webinar visit: An Overview and Guide to Clinical Trial Endpoint Adjudication

About WorldCare Clinical

WorldCare Clinical is a global CRO that employs scientific expertise, innovative technology, and operational excellence to maximize the precision and accuracy of a blinded independent central review of Phase I - IV clinical trial data. The company has worked with thousands of sites in more than 60 countries providing endpoint adjudication management services, as well as imaging CRO services, for clinical trials. WCC uses a proprietary technology platform to automate workflow, manage data, support analysis tools, and provide real-time, web-based reporting of clinical trial data. Originally founded in 1992 by the Massachusetts General Hospital (MGH) Department of Radiology, WorldCare Clinical today is a Proscan Imaging company. With over 400 employees worldwide supporting WorldCare Clinical's mission, the company continues to extend a strategic relationship with the Harvard Hospital System, as well as other leading academic institutions.

For more information on WCC's services, please visit our website at or contact:

Thomas O'Donnell,

Executive Vice President

(513) 924-5183

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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