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   Articles with "efficacy endpoints" as a keyword



UNITED: A Unified Transparent and Efficient Phase I/II Trial Design for Dose Optimization Accounting for Ordinal Graded, Continuous and Mixed Toxicity and Efficacy Endpoints

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recommendations! Published in 2025 at "Statistics in Medicine"

DOI: 10.1002/sim.70098

Abstract: A primary objective of oncology dose‐finding trials for novel therapies is to determine an optimal biological dose (OBD) that is both tolerable and therapeutically beneficial for patients in subsequent clinical trials. These new therapeutic agents… read more here.

Keywords: unified transparent; efficacy; efficacy endpoints; toxicity efficacy ... See more keywords

Factors influencing efficacy endpoints in clinical trials for new oral medicinal treatments for overactive bladder: a systematic literature review and meta-analysis

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recommendations! 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.

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recommendations! 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

Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022

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recommendations! Published in 2025 at "Clinical Trials"

DOI: 10.1177/17407745241309318

Abstract: Background/aims Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges… read more here.

Keywords: etiology; trial; primary efficacy; drug ... See more keywords

Healthcare Professionals’ Preferred Efficacy Endpoints and Minimal Clinically Important Differences in the Assessment of New Medicines for Chronic Obstructive Pulmonary Disease

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recommendations! 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