Table 2.
Reporting of primary mixed model analyses by clinical development phase
| Evaluation Item | Development Phase | P Value | All Studies (n = 39) | |
|---|---|---|---|---|
| II (n = 15) | III (n = 24) | |||
| Fixed and random effects | 15/15 (100.0%) | 22/24 (91.7%) | .51** | 37/39 (94.9%) |
| Covariance structure | 13/15 (86.7%) | 17/24 (70.8%) | .44** | 30/39 (76.9%) |
| Testing method | 5/15 (33.3%) | 9/24 (37.5%) | .79* | 14/39 (35.9%) |
| Estimation method | 4/15 (26.7%) | 7/24 (29.2%) | 1.00** | 11/39 (28.2%) |
| Computation method | 0/15 (0.0%) | 1/24 (4.2%) | 1.00** | 1/39 (2.6%) |
| Fallback strategy | 1/15 (6.7%) | 6/24 (25.0%) | .22** | 7/39 (17.9%) |
| SAP reference | 3/15 (20.0%) | 9/24 (37.5%) | .31** | 12/39 (30.8%) |
| All items specifieda | 0/15 (0.0%) | 0/24 (0.0%) | ‐ | 0/39 (0.0%) |
| Main items specifiedb | 5/15 (33.3%) | 7/24 (29.2%) | .78* | 12/39 (30.8%) |
| Main items specifiedb or SAP reference | 7/15 (46.7%) | 14/24 (58.3%) | .48* | 21/39 (53.8%) |
a
Excluding reference to SAP.
b
Main items are fixed/random effects, covariance structure, and testing method.
*
P value derived from chi‐squared test comparing proportions between study phases.
**
P value derived from Fisher's exact test comparing proportions between study phases.