Table 2.
Categories and Actions to Address Slow Accrual | Phase 1 (n=69) | Phase 2 (n=66) |
---|---|---|
Amend the Trial | 55% | 44% |
Broaden eligibility criteria | 33% | 27% |
Amend the treatment design (decrease toxicity, statistical design, revise schema) | 20% | 14% |
Amend the trial-other | 1% | 3% |
Add Institutions | 43% | 85% |
Open group-wide/group endorsement | 1% | 5% |
Add international collaborators | 0% | 3% |
Place on CTSU | 0% | 5% |
Activation/IRB approval at planned participating sites | 6% | 27% |
Add new institutions beyond those originally planned | 36% | 45% |
Promotion of Trial | 36% | 42% |
External (reach out to other communities for additional referral base) | 14% | 12% |
Internal (within own group/CTSU/Cooperative Group system) | 19% | 27% |
Increase awareness through advocacy groups and professional societies | 3% | 2% |
Promotion-other | 0% | 2% |
Administrative/Institutional Processes | 29% | 26% |
Broaden patient screening activities (by study team) to identify eligible patients | 6% | 6% |
Increase study team review processes, meetings, conference calls around trial | 7% | 5% |
Increase/change staffing | 4% | 5% |
Change administrative processes (streamlining, increase efficiencies) | 4% | 3% |
Close competing trials internally | 4% | 3% |
Administrative-other | 3% | 5% |
Funding | 6% | 11% |
Increase per case funding | 0% | 5% |
Obtain additional funding | 6% | 6% |
Proposed element not considered an action | 32% | 23% |
No action provided | 13% | 2% |
Sorted in descending order for Phase 1 trial corrective actions