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… by: Ari Gnanasakthy, MBA, MSc Principal Scientist, Patient-Centered Outcomes Assessment RTI Health Solutions Almost 40% of the American population belongs to a racial or ethnic minority. However, clinical trials for new … logistics, or time constraints. Hard-to-reach communities within the US often experience higher rates of certain …
… Analysis of Heterogeneity of Treatment Effects for Patient-Centered Outcomes Let us help you understand your … more regulatory and reimbursement agencies are requiring a thorough exploration and understanding of subgroups who … your patients. These efficient methods allow patterns within heterogeneous data to emerge so subgroups can be …
… studies can help you: Understand the natural history of a disease and its treatment Quantify and characterize product … and effective design to yield the answers you need within your budget and timeline. Our services support all … with A-CASI, EDC systems, IVRS, phone interviews, web-based, paper/fax forms, interviews, chart …
… health-related quality of life, functional status, and patient satisfaction for use in clinical trials involving both pediatric and adult patients across a wide range of conditions. In addition, we have experience … to ensure clinical relevance Focus groups and in-depth interviews with targeted populations to elicit concepts of …
… New FDA Draft Guidance For Evaluating Patient-Reported Outcomes in Clinical Trials Share on: … patients. Consideration should also be given to aspects of a given concept that may be important to patients (e.g., … of findings, it is encouraged that cognitive interviews (to evaluate the item wording and response …
… With an increased regulatory focus on incorporating patient perspectives in drug development, patient-reported … of the statistical significance of the correlations both within and between the outcomes over time. We hope that this … in 2 clinical outcome assessments. Ther Innov Regul Sci. 2018 May;52(3):306-12. doi: 10.1177/2168479017731584 …
… Negotiating post-approval study commitments Determining if a post-marketing observational study could address a safety issue of regulatory importance within a risk management plan Designing studies to evaluate … strategies and data source(s) among alternatives Conducting feasibility assessments for studies using …
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… Using RTI Rarity™ to Support Clinical Trial Diversity Requirements Local Social Inequity Score … advanced data science methods, and geospatial analytics in a risk adjustment framework. Featuring a supervised machine …
… you to communicate key product information—including clinical evidence—to US payors well in advance of approval. … and Overview Product Information and Disease Description Clinical Evidence Economic Information PIE Decks and Other … about your products ahead of FDA approval can help improve patient access to emerging therapies and devices. Work with …