Table 3.
Multivariate analysis of study initiation, completion, and publication*
|
Study initiation (n=649)
|
Study completion (n=565)
|
Study publication (n=248)
|
||||
|---|---|---|---|---|---|---|
| Study characteristics | No | Odds ratio (95% CI)† | No | Odds ratio (95% CI)‡ | No | Odds ratio (95% CI)§ |
| Type of study: | ||||||
| Others
|
509
|
1.0
|
432
|
1.0
|
NA | |
| Phase I | 140 | 3.09 (1.35 to 7.06) | 133 | 3.30 (1.34 to 7.84) | ||
| Funding: | ||||||
| None
|
54
|
1.0
|
39
|
¶ | 21
|
¶ |
| Mixed
|
42
|
13.70 (1.71 to 109.76)
|
37
|
21
|
||
| Private
|
471
|
2.56 (1.28 to 5.14)
|
418
|
167
|
||
| Public | 82 | 4.05 (1.50 to 10.94) | 71 | 39 | ||
| Adverse events: | ||||||
| None
|
NA | 448
|
1.0
|
194
|
¶ | |
| Adverse effects observed | 117 | 0.52 (0.29 to 0.94) | 54 | |||
| Results: | ||||||
| Inconclusive results
|
NA | NA | 44
|
1.0
|
||
| Confirmatory results
|
188
|
4.59 (2.21 to 9.54)
|
||||
| Invalidating results | 16 | 0.44 (0.10 to 1.86) | ||||
| Scope: | ||||||
| National
|
530
|
1.0
|
312
|
¶ | 182
|
1.0
|
| Multinational | 119 | 3.07 (1.27 to 7.40) | 253 | 66 | 2.25 (1.14 to 4.41) | |
| Design: | ||||||
| Experimental
|
558
|
¶ | 490
|
¶ | 212
|
1.0
|
| Non-experimental (descriptive/observational) | 91 | 75 | 36 | 2.83 (1.13 to 7.06) | ||
| Analysis: | ||||||
| No interim analysis
|
495
|
¶ | 487
|
¶ | 203
|
1.0
|
| Interim analysis | 86 | 78 | 45 | 2.21 (0.98 to 4.95) | ||
NA=not applicable (when testing a variable was a nonsense—for example, adverse effect could never explain initiation of a study as it occurs after initiation).
Adjusted by using forward stepwise regression on the subset of variables linked at the 0.25 level with each criterion; odds ratio of 1.00 assigned to reference category.
Variables tested: sponsor status, investigator status, revision (yes/no), planned duration, scope of recruitment (national/international), funding, phase (phase I/others, including observational), design (experimental v non-experimental).
Variables tested: sponsor status, investigator status, revision (yes/no), planned duration, interim analysis, funding, phase (phase I/others), design (experimental v non-experimental), adverse effects.
Variables tested: interim analysis, design (experimental v non-experimental), with or without direct benefit for patient, scope of recruitment (national/international), results.
Not included in final model because multivariate statistical significance was >0.25 to enter or >0.15 to stay.