Table 4.
Activity | No. of low- enrolling studies requiring each activity |
Cost of activity ($) | Cost of activity for all low-enrolling studies ($) |
Total cost ($) (FY2009) |
---|---|---|---|---|
Start-up costs | 637,080 | |||
Clinical study preparation by study team | 97 | 4,800 | 465,600 | |
Uncompensated industry clinical study start-up, budget, and institutional review board (IRB) preparation |
20* | 3,250 | 65,000 | |
Non-industry study IRB full-board review | 70 | 1,023 | 71,610 | |
Confidential disclosure agreement (CDA) negotiation |
50 | 125 | 6,250 | |
Clinical trial agreement (CTA) negotiation | 57 | 400 | 22,800 | |
Award set-up | 97 | 60 | 5,820 | |
Maintenance costs | 349,875 | |||
Continuing IRB reviews | 229 | 130 | 29,770 | |
Study modifications | 1614 | 195 | 314,730 | |
CTA amendment negotiation | 43 | 125 | 5,375 | |
Close-out costs | 1,940 | |||
Award close-out | 97 | 20 | 1,940 | |
Total: 988,895 |
A total of 45 full-board studies in FY2009 used central resources for start-up, budget, and/or IRB preparation and therefore charged non-refundable start-up fees to recoup the costs of these activities regardless of subsequent enrollment.