Factors influencing efficacy endpoints in clinical trials for new oral medicinal treatments for overactive bladder: a systematic literature review and meta-analysis
Sign Up to like & getrecommendations! Published in 2018 at "International Urology and Nephrology"
DOI: 10.1007/s11255-018-1869-y
Abstract: PurposeOveractive bladder (OAB) is a symptom-based disease; therefore, clinical trials to evaluate treatments for OAB employ a range of efficacy endpoints. Since factors that influence efficacy endpoints can affect trial outcomes, their identification could aid… read more here.
Keywords: change baseline; efficacy endpoints; clinical trials; factors influencing ... See more keywords
Oncology drugs and added benefit: insights from 3 European health technology assessment agencies on the role of efficacy endpoints.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of medical economics"
DOI: 10.1080/13696998.2021.2009711
Abstract: OBJECTIVE This study aimed to understand the impact of different efficacy endpoints on reimbursement decisions made by health technology assessment (HTA) bodies. MATERIALS AND METHODS European Medicines Agency (EMA) oncology product marketing authorizations were screened… read more here.
Keywords: benefit; efficacy endpoints; added benefit; oncology ... See more keywords
Healthcare Professionals’ Preferred Efficacy Endpoints and Minimal Clinically Important Differences in the Assessment of New Medicines for Chronic Obstructive Pulmonary Disease
Sign Up to like & getrecommendations! Published in 2019 at "Frontiers in Pharmacology"
DOI: 10.3389/fphar.2019.01519
Abstract: Background Registration authorities evaluate effects of new medicines for chronic obstructive pulmonary disease (COPD) on airway obstruction, dyspnea, health status and exacerbations. To establish clinical relevance, minimal clinically important differences (MCIDs) are used. The aim… read more here.
Keywords: new medicines; efficacy endpoints; registration authorities; healthcare professionals ... See more keywords