The cost of a study depends on many factors, especially the number of sites conducting the study, the number of patients involved, and whether the study treatment is already approved for medical use.
The expenses incurred by a pharmaceutical company in administering a Phase III orIV clinical trial may include, among others:
* production of the drug(s) or device(s) being evaluated
* staff salaries for the designers and administrators of the trial
* payments to the contract research organization, the site management organization (if used) and any outside consultants
* payments to local researchers and their staff for their time and effort in recruiting test subjects and collecting data for the sponsor
* the cost of study materials and the charges incurred to ship them
* communication with the local researchers, including on-site monitoring by the CRO before and (in some cases) multiple times during the study
* one or more investigator training meetings
* expense incurred by the local researchers, such as pharmacy fees, IRB fees and postage
* any payments to subjects enrolled in the trial
* the expense of treating a test subject who develops a medical condition caused by the study drug
These expenses are incurred over several years.
In the US, sponsors may receive a 50 percent tax credit for clinical trials conducted on drugs being developed for the treatment of orphan diseases. National health agencies, such as the US National Institutes of Health, offer grants to investigators who design clinical trials that attempt to answer research questions of interest to the agency. In these cases, the investigator who writes the grant and administers the study acts as the sponsor, and coordinates data collection from any other sites. These other sites may or may not be paid for participating in the study, depending on the amount of the grant and the amount of effort expected from them. Using internet resources can, in some cases, reduce the economic burden.