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… rate of decline in kidney function over a longer period, using existing clinical trial data. THE CHALLENGE Our client … receiving standard of care. We adjusted for confounding using covariate matching and regression adjustment to obtain …
… can help you, your patients, regulators, and prescribers understand the real-world use, value, and safety of your products. Observational … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… of new cardiovascular therapies,” explains Dr. Mangel. The theory that the aorta actively contracts in rhythm with the …
… measure real-world treatment patterns, healthcare resource use, HRQOL, and indirect burden associated with chronic … idiopathic urticaria (CIU). They needed this data to understand the natural history of the disease and inform …
… Real-World Comparative Effectiveness Analysis for Use in Cost-Effectiveness Modeling in Multiple Sclerosis …
… Ischemic Stroke Treatment OPPORTUNITY Our client wanted to understand if the costs of adding computed tomography …
… (FDA) for cancer treatment found that the agencies use different standards to evaluate evidence from … trials. Study sponsors pursuing PRO drug labeling who understand these differences can use that knowledge to guide … feedback on specific outcome measures? • What are the main challenges sponsors face when including PRO-related endpoints …
… Plasma-derived products Small biotech drugs (2026-2028) Using the guidance on drug selection criteria, manufacturers … consider therapeutic alternatives to their product(s) and understand how to narrow the list if there are many … Manufacturer Engagement CMS will provide public engagement opportunities for patients, providers, advocacy groups, and …
… the inclusion of clinical data affect planned or pending publications? Manufacturers should determine the appropriate … funnel. The overall patient population can be described using epidemiological data. In cases where a product targets … be useful to develop a funnel diagram to help the payer understand the size of the population to be treated. In some …
… that address high unmet medical needs as well as the use of comparative clinical trials, among other factors. How … are equipping themselves to address potential challenges they may face in drug development as they move … Health Solutions. From very early on, we help our clients understand disease burdens, unmet medical needs, and patient …