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How Do We Get Drug Labeling Based on Patient Reported Outcomes? With Ari Gnanasakthy , MBA, MSc, Principal Scientist, Patient-Centered Outcomes Assessment at RTI Health Solutions. Transcript A frequent request we receive from clients relates to labeling, …
… areas including dermatology, infectious diseases, movement disorders, oncology, vaccines, and rare diseases. In her role …
… HEOR and medical technology experts to review the client’s data. Our team included researchers who have worked at NICE … and digital technologies. Our team reviewed clinical data on the technology that had not previously been assessed … on existing evidence gaps, the likelihood that the data assessed would facilitate a change to the current NICE …
… Our client wanted to leverage real-world effectiveness data to compare the long-term clinical and economic value of … treatment effectiveness—such as studies that evaluate data from real-world registries—are not typically designed to … modeling methods. OUR APPROACH We utilized data from a disease registry including roughly 78,000 patient …
… developing protocols and analysis plans, statistical data analysis and interpretation, and producing study … in Canada, where she worked with a variety of real-world data sources to conduct observational studies and health … She has worked on projects that span a variety of therapeutic and clinical areas including cardiovascular and …
… Instrument/method selection Study implementation Utility data analysis Data incorporation into cost-utility models Country Agency … of measuring QALYs is to use quality-of-life or utility data. Australian-based preference weights are preferred for …
… diseases, and rare diseases such as lysosomal storage disorders (Fabry, Gaucher, organic acidemia). …
… neurology (multiple sclerosis), vaccines, and rare disorders. Prior to joining RTI-HS, Mr. Spencer worked as a …
… and team management, financial planning and monitoring, data protection and ethics compliance, quality control and … postapproval safety studies (PASS) in several therapeutic areas, settings and analytical approaches … including those that use local-level programming or common data model (CDM) and federated analysis approach. These range …
… in the analysis of comparative studies using categorical data methods, nonparametric statistics, multiple comparisons …