Factors influencing approval of a trial and IRB members’ judgements whether the proposed trial will benefit current versus future patients
| Variable | OR (95% CI): trial approval | OR (95% CI): benefit of current patients | OR (95% CI): benefit of future patients |
|---|---|---|---|
| Competing interest of a clinician as investigator vs caregiver | 1.1 (0.79 to 1.52) | 1.08 (0.69 to 1.67) | 1.14 (0.74 to 1.74) |
| No requirement for discontinuing of standard therapy (adherence to standard treatment) | 3.84 (2.7 to 5.55)** | 2.17 (1.39 to 3.44)** | 1.66 (1.07 to 2.56)* |
| Testing and procedures that are intended to generate scientific knowledge vs necessary for patient care | 1.06 (0.77 to 1.49) | 0.86 (0.56 to 1.35) | 1.04 (0.67 to 1.58) |
| Purpose of the trial (explanatory vs pragmatic) | 1.18 (0.85 to 1.63) | 1.43 (0.91 to 2.24) | 1.16 (0.75 to 1.78) |
| Therapy type (gene therapy vs chemotherapy vs over counter medications) | 1.16 (0.97 to 1.41) | 1.02 (0.8 to 1.31) | 1.04 (0.82 to 1.34) |
| Severity of condition/disease (life-threatening vs non-life-threatening) | 2.04 (1.47 to 2.86)** | 1.4 (0.9 to 2.17) | 1.78 (1.15 to 2.28)** |
| Uncertainty about treatment effects (varied from 1% to 100%) | 1.13 (1.08 to 1.19)** | 1.54 (1.4 to 1.7)** | 1.27 (1.18 to 1.37)** |
For binary outcome: *significant at 0.05; **significant at 0.001; ORs are baseline adjusted for gender, age, review board status, education level, years on IRB, self-reporting as a scientist and quiz score.
IRB, institutional review board.