Table 2 Top 10 most frequent additional comments about how eligibility criteria are developed or useda
Rank | Comment type | n | Proportion of all meaningful comments (n = 229)b |
|---|---|---|---|
1 | Support for earlier review of protocol/eligibility criteria | 66 | 29% |
2 | Want clarity/consistency of information | 20 | 9% |
3 | Already feedback to sponsor when criteria problematic | 14 | 6% |
4 | Criteria are often too restrictive | 12 | 5% |
5 | Criteria should be more inclusive of “real-world” patients | 11 | 5% |
6 | Support for sponsor-provided eligibility checklists | 9 | 4% |
7 | Happy to ask sponsor if have queries about criteria | 8 | 3% |
=8 | Justification for criteria would be useful | 7 | 3% |
=8 | Criteria can be long and complex | 7 | 3% |
=10 | Criteria need to be more specific | 6 | 3% |
=10 | Research Nurse involvement is/could be key in ensuring criteria quality | 6 | 3% |
=10 | The right people/enough people already tend to be involved in protocol development | 6 | 3% |