Table 5.
Reason for requesting further research | ACDs | Final guidance | ||
---|---|---|---|---|
OIR | AWR | OIR | AWR | |
None stated | 1 | 0 | 4 | 0 |
Clinical effectiveness | ||||
Need for more evidence on relative effectiveness | 17 | 2 | 16 | 0 |
Need for data on relative effectiveness in the target OIR population | 12 | 3 | 8 | 1 |
Need for long-term data | 8 | 5 | 3 | 4 |
Need for information on adverse effects | 3 | 3 | 1 | 3 |
Need for data on natural history/disease progression | 1 | 1 | 0 | 0 |
Need for further evidence to support mechanism of treatment action | 4 | 0 | 3 | 0 |
Cost effectiveness | ||||
Uncertainty in cost-effectiveness estimates | 10 | 3 | 6 | 0 |
Need for cost-effectiveness data with an appropriate comparator | 2 | 0 | 1 | 1 |
Need for more data on quality-of-life impact | 4 | 2 | 3 | 0 |
Need for more data on costs | 1 | 0 | 1 | 0 |
Other uncertainties | ||||
Budget impact | 0 | 0 | 0 | 0 |
Investment and reversal costs | 0 | 0 | 0 | 0 |
Potential impact on ongoing research | 0 | 0 | 0 | 0 |
Note that there may be multiple ACDs for each appraisal and that there may be more than one stated rationale for requiring further research
ACD Appraisal Consultation Document, AWR approval with research, OIR only in research