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 them to the Principal Investigator, Director of Research, and respective manager of the department. The Director of Research subsequently slates the non-accruing clinical trials for review at RAC. The regulatory coordinator notifies the Principal Investigator that the protocol will be reviewed for accrual at RAC and requests an explanation from the Principal Investigator about the slow accrual and their rationale for keeping the clinical trial open. At RAC, the committee defines the duration for an extension to keep the clinical trial open and makes recommendations to the Principal Investigator (FDA, 2011)
Low-reimbursing clinical trials, often considered for their scientific merit and promising treatment, could become an administrative challenge when accrual is low. Without a system to monitor accrual and terminate non-accruing trials in a timely fashion, major institutions continue to waste monetary and staff resources in keeping non-accruing trials in their pipelines. The Holy Cross Hospital Office of Protocol Regulations estimates that the costs for maintaining a non-accrual trial are averaging $3,300 per year. These costs include the regulatory coordinator time for processing the regulatory...