Patient-Reported Outcomes

Throughout the product lifecycle, data from patient-reported outcome (PRO) measures and other clinical outcome assessments (COAs)—such as observer-reported outcome (ObsRO), clinician-reported outcome (ClinRO), and performance-based outcome (PerfO) measures—provide an accepted and often actively solicited source of evidence in the evaluation, approval, and marketing of pharmaceuticals. Such measures are often critical to assess the impact of disease and demonstrate the drug benefits most important to patients and other stakeholders.

Evaluating PROs is critical for products that treat conditions with symptoms and treatment effects known only to patients. In addition, data generated by PRO measures and other COAs are particularly important in conditions where the intention is to alleviate symptoms, facilitate functioning, or improve quality of life rather than to cure. There is also growing recognition that the patient's perspective is an important component of health technology assessment (HTA) given that patients are the stakeholders most affected by HTA decisions.

To provide you with comprehensive support from clinical development to post-marketing, the PRO team routinely collaborates with other RTI-HS experts in health economics, market access, health-preference assessment, survey research, and biostatistics.

Our PRO and COA services include measurement strategiesinstrument developmentpsychometric evaluation, utility assessmentmarket research, and regulatory guidance and support.

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