Table 3.
Error | Effect on Clinical Trial |
Where Problem Occurs |
Is Problem Detectable? |
Is Problem Preventable? |
Where Problem is Preventable |
---|---|---|---|---|---|
Inaccuracy [35] | Numerator distortion undermining power |
In CT | No | Yes | Pre-CT with criteria for accuracy |
Dose range [12] | Effective drug dose not tested |
In CT | No | Yes | Pre-CT with evidence of effects on mechanism in humans |
Lax monitoring: entry criteria not met by subjects [27] |
Trial report misrepresents subject sample |
In CT | No | Yes | Pre-CT with training and In CT with off site evaluators |