Development of a Charter for an Endpoint Assessment and Adjudication Committee
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Steve Kradjion, BA* Executive Directoc Regulatory Affairs, Vical Incorporated, San Diego. California John Gutheil, MD* Executive Directoc Clinical Research, Vical Incorporated, San Diego, California Anna
M. Baratelle ASRT,
(R), (MR) Director of Clinical Education Steven G. Einstein, MS Director. Clinical Trial Consulting Services
Bio-Imaging Technologies. Inc. 826 Newtown-Yardley Road Newtown, PA 18940 David C. Kaslow, MD Chief Scientific Officer, Research and Development Administration, Vical Incorporated. San Diego, California
Key Words Endpoint; Endpoint assessment; Endpoint Assessment and Adjudication Committee charter: Pivotal trial; Data Monitoring Committee Correspondence Address David C. Kaslow, MD, Chief Scientific Officer Vical Incorporated, 10390 Pacific Center Court, San Diego, California, 92121 (e-mail: dkaslow @vical.corn).
'Mr. Kradjian is now Principal Consultant. Regulatory Affairs, at Kradjian Consulting, LLC in San Diego, California. Dr. Gutheil is now Vice President of Medical Research at Favrille Incorporated in San Diego. California.
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Development of a Charter for an Endpoint Assessment and Adjudication Committee The significantprogrammatic risk inherent in a decision to advance a product candidate to a latephase of clinical development can be significantly reduced when there is complete objectivity in the data assessment and analysis underWng the decision to proceed in development. Such objectivity is especially needed in fields in which endpoints are determined by clinical or radiological examinations, rather than by predefined labomtory measurements. A charterfor an independent Endpoint Assessment and Adjudication Committee was developed for the unbiased assessment of clinical outcomes in a multicentec phase 3 oncology trial to enable a uniform, controlled-assessmentprocess that
INTRODUCTION IMPORTANCE OF OBJECTIVE CONCLUSIONS FROM CLINICAL RESEARCH The importance of reaching objective and definitive conclusions from clinical research and development is essential to clinical drug development. Completely excluding bias during this process is of critical importance. The lessons learned by sponsors (1)whose pivotal trial data were found not to support the conclusions set forth in a license application can reveal experiences that are best not repeated. While the critical decision to advance a product candidate to a very late phase of clinical development carries significant business risk, that risk is reduced when there is real objectivity in the interpretation of the data underlying the decision to proceed in development. Vical Incorporated completed a pivotal, multicenter, phase 3 trial of an immunotherapeutic product in a metastatic melanoma population. In an effort to increase the accuracy of the study's conclusions and eliminate bias, Vical collaborated with the U.S. Food and Drug Administration (FDA) and a state-of-the-art bio-imaging
would be independent of the sponsor. The Endpoint Assessment and Adjudication Committee charter enabled objectivity of endpoint assessment and app
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