The cost associated with conducting clinical trials is one area that many institutions fail to consider. The “hidden costs” as I like to call them or administrative fees incurred by institutions for maintaining non-enrolling clinical trials is just one example. At a time when costs are rising in practically every area of running clinical trials, it is absolutely necessary to have a budget that adequately meets the financial needs of a study regardless if the study is enrolling patients or not.
The research department at Holy Cross Hospital implemented a program in August 2010 to annually review patient accrual and the continuing scientific viability of pharmaceutical and NCI-sponsored clinical trials. Utilizing our Research Advisory Committee (RAC) comprised of medical physicians and research personnel, we are able to analyze the costs and look at the feasibility of every clinical trial. Guided by a protocol assessment checklist (see appendix II), our committee can determine whether to proceed with a potential study or not to. The implementation of the program was triggered upon reviewing the protocol database and identifying many non-accruing clinical trials that have remained unnecessarily open for more than a year.
The Food and Drug Administration (FDA) regulations require continuing review of research to be conducted at intervals appropriate to the degree of risk, but not less than once per year (21 CFR 56.108). At Holy Cross Hospital, one designated regulatory coordinator submits continuing reviews for every clinical trial to the Institutional Review Board (IRB) one month prior to the study expiration date. During this process, the regulatory coordinator identifies the non-accruing trials and reports ...
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