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Report: Average Phase I Trial Costs Approach $9,000 Per Patient Per Month

By Pharmaceutical Processing | September 27, 2013

A study by Cutting Edge Information found that pharmaceutical companies measure cost per patient per month to allow trials of different sizes and durations to be compared easily. This measurement also helps to illustrate the high costs associated with delays.

The study, “Phase I Clinical Trials: Optimizing Cost-Drivers for Clinical Pharmacology Programs,” found that neurology and central nervous system (CNS) trials cost the most at $8,943 per patient per month. The trials’ high price tag, combined with a relatively short average duration of 9.6 months helps CNS top the list among all surveyed therapeutic areas.

Surveyed cardiology and respiratory Phase I trials’ short average durations (8.6 months and 5.0 months, respectively) help to elevate these therapeutic areas above oncology in terms of cost per patient per month. In fact, oncology trials’ relatively average long duration (36 months) gives the therapeutic area an average cost per patient per month of $2,822.

The research team at Cutting Edge Information analyzed cost per patient per month data for oncology, cardiology, CNS and gastroenterology trials. The following are highlights from each therapeutic area:
•An oncology trial reported the second highest cost per patient per month ($20,635) of all trials in this study behind only one CNS trial.
•A cardiology trial, which incurred the lowest cost per patient per month at $2,375, lasted five months longer than the other trials studied. This is a rare instance when shorter trials incur higher total costs — likely the result of imaging procedures built into their protocol.
•CNS trials have the widest range of costs per patient per month at $20,606.
•Gastroenterology trials report the narrowest range of cost per patient per visit — only $347.

“Phase I Clinical Trials: Optimizing Cost-Drivers for Clinical Pharmacology Programs,” ( http://www.cuttingedgeinfo.com/research/clinical-development/phase-i-clinical-trials/ ) examines the critical cost drivers when budgeting for Phase I trials. Use this report to:
•Manage critical cost-drivers when budgeting for Phase I trials.
•Save time and prevent costly delays with early strategic planning.
•Balance the number and quality of trial sites during site selection to manage patient enrollment and drop-off rates.

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