Table 5.
Total costs by functional group.
| Functional Group | RCT Design |
Total Cost Differences |
|||
|---|---|---|---|---|---|
| Registry-Based | Pragmatic | Explanatory | Explanatory vs. Pragmatic | Pragmatic vs. Registry-Based | |
| Leadership | |||||
| Steering Committee | 20,000 | 20,000 | 20,000 | 0 | 0 |
| Trial Leadership | 530,819 | 533,342 | 942,986 | 409,644 | 2523 |
| Project Management | 194,858 | 206,227 | 304,803 | 98,576 | 11,369 |
| Subtotal | 745,677 | 759,569 | 1,267,900 | 508,219 | 13,893 |
| Site Mgmt & Monitoring | |||||
| Site Coordination | 230,328 | 376,928 | 408,283 | 31,355 | 146,600 |
| Monitoring | 196,578 | 293,192 | 616,582 | 323,391 | 96,614 |
| Subtotal | 426,905 | 670,119 | 1,024,865 | 354,745 | 243,214 |
| Data Mgmt & Statistics | |||||
| Data and Safety Monitoring Board | 23,172 | 23,172 | 56,250 | 33,078 | 0 |
| Clinical Events Committee | 0 | 0 | 331,262 | 331,262 | |
| Clinical Data Mgmt | 191,872 | 313,039 | 370,317 | 57,278 | 121,167 |
| Registry Access Fee | 158,531 | −158,531 | |||
| Statistics | 185,918 | 187,083 | 585,544 | 398,461 | 1165 |
| Subtotal | 559,493 | 523,294 | 1,343,373 | 820,079 | −36,199 |
| Other Services | |||||
| Safety Surveillance | 77,867 | 79,397 | 79,397 | 0 | 1530 |
| Quality Assurance | 0 | 0 | 3105 | 3105 | 0 |
| Contracts/Payments | NA | NA | NA | NA | NA |
| Communications | 0 | 0 | 119,701 | 119,701 | 0 |
| Regulatory Services | 18,932 | 17,788 | 17,788 | 0 | −1144 |
| Subtotal | 96,799 | 97,185 | 219,990 | 122,806 | 386 |
| Miscellaneous Activities | |||||
| Meetings, Travel, Suppls | 9624 | 9989 | 207,401 | 24,389 | 365 |
| Randomization and Support | 148,613 | 148,613 | 0 | ||
| Subtotal | 9624 | 9989 | 356,014 | 346,026 | 365 |
| Site Payments | 1,430,006 | 2,104,706 | 5,928,232 | 3,823,526 | 674,700 |
| Total Costs | 3,268,504 | 4,164,863 | 10,140,263 | 5,975,401 | 896,358 |
Mgmt = Management.
Suppls = Supplies.
NA = These services are included in government supported trial indirect costs.