Table 2.
Estimated cost savings associated with registry utilisation versus standard trial design, as a function of study size and other key trial characteristics, assuming registry data accessed locally.
| Cost savings (95% CI) |
|||
|---|---|---|---|
| 10,000 data elements |
Study size* 100,000 data elements |
1,000,000 data elements |
|
| Research coordinator time per data element | |||
| ½ minute | $−613 (−$20,512 to $15,904) | $4547 (−$17,676 to $34,849) | $522,050 ($35,922–1,946,536) |
| 1½ minutes | $9,864 (−$15,421 to $54,562) | $152,314 ($4363–591,657) | $1,576,810 ($113,08–5,847,937) |
| 5 minutes | $46,828 (−$6,674 to $193,799) | $522,050 ($31,799–1,988,146) | $5,248,845 ($384,909–19,425,286) |
| # of centres | |||
| 1 | $15,532 ($1,903–57,100) | $157,982 ($11,327–575,888) | $1,584,478 ($114,378–5,762,109) |
| 10 | $9864 (−$2,120 to $50,753) | $152,314 ($4363–591,657) | $1,576,810 ($110,353–$5,756,799) |
| 200 | −$109,790 (−$131,148 to −$72,972) | $32,660 (−$69,542 to $425,076) | $1,457,156 ($82,468–5,573,837) |
| % data abstracted from registry | |||
| 1 | −$4635 (−$4,846 to −$2,216) | −$3052 (−$4370 to $2,227) | $12,776 ($−4387 to $63,527) |
| 90 | $9864 ($1014–35,040) | $152,314 ($4363–591,657) | $1,576,810 ($107,742–5,850,295) |
| 100 | $11,493 ($1941–40,432) | $169,771 ($12,445–632,672 | $1,752,745 ($123,501–6,481,290) |
| Research coordinator salary | |||
| $29,407 | $2310 ($734–8018) | $75,041 ($5147–280,119) | $802,351 ($57,089–2,893,852) |
| $57,596 | $9864 ($1182–37,485) | $152,314 ($4363–591,657) | $1,576,810 ($114,226–5,674,802) |
| $117,528 | $25,925 ($2010–99,466) | $316,602 ($21,551–1,152,697) | $3,223,370 ($236,132–11,586,442) |
| % of data requiring manual validation | |||
| 0.1 | $10,237 ($1280–39,175) | $155,449 ($10,218–579,240) | $1,607,563 ($113,372–5,853,231) |
| 2 | $9864 ($1068–38,643) | $152,314 ($4363–591,657) | $1,576,810 ($109,967–5,754,198) |
| 5 | $9275 ($870–37,738) | $147,365 ($8738–555,247) | $1,528,254 ($105,710–5,595,522) |
| Wage index, standard trial design** | |||
| 0.5 | $2170 ($539–8089) | $73,395 ($4597–279,521) | $785,644 ($53,629–2,877,068) |
| 1 | $9864 ($1113–38,582) | $152,314 ($4363–591,657) | $1,576,810 ($110,353–5,756,798) |
| 1.5 | $17,558 ($1768–69,244) | $231,233 ($14,889–858,067) | $2,367,976 ($167,109–8,637,726) |
| Fringe rate | |||
| 0.2 | $7892 ($909–31,124) | $121,851 ($7827–459,078) | $1,261,449 ($88,296–4,635,207) |
| 0.5 | $9864 ($1134–39,020 | $152,314 ($4363–591,657) | $1,576,810 ($110,371 to $5,794,010) |
| 0.7 | $11,180 ($1384–44,222) | $172,622 ($11,088–650,361) | $1,787,051 ($125,087–6,566,543) |
| # software platforms | |||
| 1 | $9864 ($1094–38,582) | $152,314 ($4363–591,657) | $1,576,810 ($110,352–5,756,799) |
| 20 | $2573 (−$3555 to $30,199) | $145,023 ($3660–561,827) | $1,569,519 ($103,076–5,748,996) |
| 100 | −$28,129 (−$18,702 to −$9,852) | $114,321 (−$14,443 to $526,209) | $1,538,817 ($75,754–5,716,833) |
| Indirect rate | |||
| 0.5 | $8704 ($989–37,035) | $134,395 ($8558–508,693) | $1,391,303 ($97,015–5,085,144) |
| 0.7 | $9864 ($1121–38,593) | $152,314 ($4363–591,657) | $1,576,810 ($109,951–5,763,163) |
| 0.9 | $11,024 ($1250–43,133) | $170,234 ($10,839–636,745) | $1,762,318 ($122,886–6,441,183) |
| Registry personnel experience level*** | |||
| 0.7 | $9864 ($1113–38,583) | $152,314 ($4363–591,657) | $1,576,810 ($110,352–5,756,799) |
| 5 | $14,374 ($3358–49,401) | $156,924 ($12,531–575,122) | $1,581,320 ($114,201–5,762,129) |
| 10 | $15,191 ($3855–50,951) | $157,641 ($13,092–575,700) | $1,582,137 ($114,888–5,762,609) |
| Wage index, registry-based trial design** | |||
| 0.5 | $12,626 ($1217–49,615) | $155,076 ($10,114–572,914) | $1,579,572 ($111,907–5,760,444) |
| 1 | $9864 ($1113–$38,582) | $152,314 ($4363–591,657) | $1,576,810 ($110,352–5,756,799) |
| 1.5 | $7102 ($1079–23,315) | $149,553 ($9306–564,946) | $1,574,049 ($108,700–5,754,717) |
Cost savings are calculated varying two study characteristics at a time and holding all other characteristics at base case values defined in Table 1.
*
Study size = number of total data elements (# of patients * # of discrete variables)
**
Wage index = a multiplier of base case salaries for a specific trial design’s personnel that accounts for regional or other variations in salary.
***
Experience = a multiplier of time to conduct each component of a registry-based trial; time decreases with prior experience with registry-based trials.