Development of a Charter for an Endpoint Assessment and Adjudication Committee

Abstract

The significant programmatic risk inherent in a decision to advance a product candidate to a late phase of clinical development can be significantly reduced when there is complete objectivity in the data assessment and analysis underlying 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 laboratory measurements. A charter for an independent Endpoint Assessment and Adjudication Committee was developed for the unbiased assessment of clinical outcomes in a multicenter, phase 3 oncology trial to enable a uniform, controlled-assessment process that would be independent of the sponsor. The End-point Assessment and Adjudication Committee charter enabled objectivity of endpoint assessment and approximated the critical review that the U.S. Food and Drug Administration (FDA) might impose on clinical endpoint data. The Endpoint Assessment and Adjudication Committee charter was reviewed rigorously in consultation with the FDA, resulting in a charter that may prove to be a useful example in generating independent assessment of pivotal clinical outcomes. The Endpoint Assessment and Adjudication Committee charter is available for review at http://www.vical.com/eaaccharter.pdf.