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Looking for a Publication? Search the bibliography for: publications assessment therapy changes drug discontinuation among crohns disease patients using
… be considered when evaluating PROs intended to support drug submissions as well as medical devices. The draft offers … feasible, rather than creating new measures. Concepts and changes in concepts measured by the PRO instrument should be … about the amount of change that is clinically meaningful. Assessment of a PRO instrument as “fit for purpose” is …
… bring more equity to health technology assessments (HTAs), drug and medical device developers are looking to understand … she is seeing product developers respond to Joint Clinical Assessment (JCA) regulation and Medicare price negotiations. … more tenable. Individual Drugs in Development We will see changes in strategy, particularly for phase 2b or 3 trials, …
… Evidence Assessment for a Digital Medical Technology OPPORTUNITY Our … technology had previously undergone a health technology assessment by the National Institute for Health and Care … The client’s digital diagnostic technology was in a busy disease area with multiple guidelines. This made …
… Identifying an Appropriate Drug for Comparative Safety Research Antiepileptic Drugs in Pregnancy: Searching for a Reference Drug for Comparative Safety AV Margulis , AS Oberg, S … confidence interval. Bigger dots reflect larger numbers of patients in the study. Our literature review shows quite …
… Recent FDA Drug and Device Guidelines for Sharing Pre-Approval … July 17, 2018 Communication of Pre-approval Information by Drug and Device Manufacturers to Payers in the US In the US, … often respond to these unsolicited requests from payers using evidence requirements outlined in the Academy of …
… How Do We Get Drug Labeling Based on Patient Reported Outcomes? With Ari … , MBA, MSc, Principal Scientist, Patient-Centered Outcomes Assessment at RTI Health Solutions. Transcript A frequent … proposition in simple language that can be understood by patients or other stakeholders as well. There is no point of …
Navigating EU Joint Clinical Assessments and Joint Scientific Consultations From January 2025 Onward
… centralise the clinical domains of the health technology assessment (HTA) process on a European level. Non-clinical … that access to innovative medicines is accelerated for EU patients. Whether the new legislation and centralised process … in advance, and nimbly adjust to the final scope and label changes. In addition, we provide a range of strategy, …
… our clients on projects to research gastrointestinal (GI) disease, GI treatment, and complications and comorbidities of … studies Cohort and case-control studies Consulting on drug development from preclinical through postmarketing … models (cost effectiveness, budget impact, Markov) Drug utilization studies Economic burden of illness studies …
… Comparison Challenge on Cost-Effectiveness Models in Alz Disease and Related Dementias William L Herring, PhD Executive Director, Health Economics Transcript As disease-modifying therapies for Alzheimer’s disease, or AD, … submit model results based on a common benchmark scenario using hypothetical clinical trial data for a treatment for …
… patients and their caregivers to help inform the drug development process. The Alzheimer’s Disease Patient and … (AD PACE) initiative is a first-of-its-kind collaboration among pharmaceutical companies, advocacy organizations, … Hauber, PhD, Senior Economist and VP of Health Preference Assessment at RTI-HS, will lead the AD PACE What Matters Most …