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Table 1 Factors that affect the cost of PRO development

From: Incorporating development of a patient-reported outcome instrument in a clinical drug development program: examples from a heart failure program

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.

  1. PRO patient-reported outcome, IRBs Institutional Review Boards