What does your measurement reliability framework look like?
Clinical trials with high levels of subjectivity also tend to encounter increased variability. For these trials, it is crucial to have a framework in place that supports measurement reliability. Each component of the trial can—and should—be calibrated consistently and effectively to achieve the intended results.
Optimizing the performance of each study participant is essential in preventing data quality risks in a given program. For example, when patients are unable report their pain accurately, it can have negative consequences on patient reported outcomes and trial data. Likewise, the measurement instruments themselves must be built to provide information that is precise and reliable. Otherwise, the ability to truly demonstrate a drug’s efficacy is minimized. Add to this: issues of protocol adherence, confounders, rescue med consumption, and diary non-compliance, and you dramatically increase the possibility of a failed trial.
Establish your measurement reliability framework and sharpen the accuracy of your clinical trial data.