Factor | Considerations |
---|---|
Patient and site recruitment | Use of vendors to identify and recruit patients, payment for participation in qualitative studies, ease of access to target patient groups |
Multiple stakeholder involvement | PRO experts, IRBs, clinicians, patients, researchers, PRO and ePRO vendors |
Number of iterations | Multiple rounds of concept elicitation interviews and cognitive interviews to achieve saturation of concepts and satisfactory evidence of content validity |
Delays in clinical program unrelated to PRO development | Need to update reviews prior to regulatory approval, increased risk of staff changes reducing efficiency of process |
Approach selected for quantitative validation | Stand-alone vs regular clinical trials |
Mode of instrument administration | ePRO vs pencil and paper vs mixed mode; need to demonstrate instrument equivalence |
Clinical trial design | Number of languages and cultural adaptations needed |
Dissemination strategies | Dossier preparation, conference presentations, manuscripts, etc. |