Financing Clinical Trials Research at Kaiser Permanente

Abstract

Kaiser Foundation Research Institute (KFRI) has developed and implemented in the Kaiser Permanente (KP) Northern California Region a comprehensive system for assessing and budgeting costs of clinical trials and for negotiating study budgets with research sponsors. KFRI has shared its methodology and results with research leaders throughout KP. This article communicates the background and current status of this effort to the KP research community at large and specifically to all KP physicians interested in clinical trials research. KFRI hopes to benefit KP as an organization by giving its current and future researchers a deeper understanding of the economic and financial factors underlying clinical trials and the importance of using a systematic approach to developing and negotiating research budgets. As a research organization, KP has unique strengths as well as unique financial concerns. This article presents basic economic and financial concepts as the basis for understanding cost assessment and the logic of budget development. Some key elements of successful negotiation strategies are also presented. Prospective KP principal investigators are urged to take a systematic approach to assessing and budgeting the costs of clinical trials. KFRI is prepared to assist KP physicians with this task and to negotiate industry-sponsored clinical trials budgets with sponsors.