Our multidisciplinary patient-reported outcomes (PRO) team can help you assess the impact of diseases on patients and demonstrate the drug benefits most important to them. We will work with you to develop the strategy and tools to provide payers, providers, and regulators with a better understanding of the patient experience and perspective to improve your product in the marketplace.
Our Expertise
Consulting with PRO Experts
FDA PRO Guidance
Development and Support of PRO Measurement Strategies
RTI-HS has extensive experience in many therapeutic areas, including qualitative work with patients, partners, and physicians; development of PRO instruments and measurement strategies for clinical trials; design and implementation of patient surveys and observational studies; reviews of the literature; and critical appraisals of available instruments.
RTI-HS has developed and evaluated the psychometric properties of numerous PRO measures for use in clinical trials to assess a wide variety of health outcomes such as symptom severity, health-related quality of life, functional status, and patient satisfaction.
RTI-HS has negotiated with the FDA's Study Endpoint and Label Development (SEALD) group and a number of reviewing divisions to select and support measurement strategies acceptable to the FDA following the release of the draft PRO guidance (in 2006).
RTI-HS is focused on the client and on delivery of a high quality product.
For each project, a team is selected based on the members’ therapeutic experience as well as their expertise in instrument development and validation.
Deliverables
Our project objectives always define the deliverables. Depending on your unique needs, your PRO deliverables may include:
PRO instruments and measurement strategies for use in clinical trials
PRO validation study designs, analysis plans, results, and reports
PRO dossiers and documentation to support labeling claims
Manuscripts and abstracts
Study reports
Training materials
Conference posters and presentations
Related Services
For your projects that may have cross-functional requirements, we also offer the following complementary services:
