Effective training from UBC, applied consistently to raters across a wide range of rating instruments, has been shown to increase scoring standardization and precision with clinician-rated scales. This leads to successful study design and effective study implementation.
UBC’s consistent training approach is equally effective when dealing with patient-reported outcome (PRO) instruments.
PRO instruments can be used as effective endpoints in clinical research. The amount and type of evidence required by the FDA to support labeling claims measured by PRO instruments is not different than any other endpoint, so inter-patient variability – like inter-rater variability – must be minimized.
According to the Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, the FDA notes that increased training for both clinicians and patients will be critical to ensuring the effective use and application of PRO assessments. The FDA suggests that study quality can be optimized through standardized instruction for investigators, standardized training and instruction for patients and standardized interviewer training and training format.
A sample training program designed by UBC to satisfy the draft Guidance might include:
- Disease-specific didactic training for investigators and site personnel regarding the influence of the targeted disease on patient comprehension and PRO reporting
- Protocol-specific didactic training for clinicians regarding the instruments
- Comprehensive patient education materials delivered not only at study initiation, but throughout the duration of a subject’s participation