Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm Birth
| Autor: | Susan McCune, Lynn D. Hudson, Elektra J. Papadopoulos, Sarah Sheehan, Gerri Baer, Michelle Campbell, Robert Lim, Gregory W. Daniel, Morgan H. Romine |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Pharmacy Disease Health outcomes Article Pregnancy medicine Humans Pharmacology (medical) Intensive care medicine Pharmacology Toxicology and Pharmaceutics (miscellaneous) Bronchopulmonary Dysplasia business.industry Treatment development Infant Newborn Public Health Environmental and Occupational Health Limiting medicine.disease Clinical trial Patient population Bronchopulmonary dysplasia Premature Birth Female Morbidity business Infant Premature |
| Zdroj: | Ther Innov Regul Sci |
| ISSN: | 2168-4804 2168-4790 |
| DOI: | 10.1007/s43441-020-00153-z |
| Popis: | Chronic pulmonary and respiratory conditions associated with preterm birth are incompletely characterized, complicating long-term treatment and development of more effective therapies. Stakeholders face challenges in the development of validated, clinically meaningful endpoints that adequately measure morbidities and predict or represent health outcomes for preterm neonates. We propose in this paper a research agenda, informed by the input of experts from a 2018 workshop we convened on this topic, to advance endpoint and treatment development. We discuss the necessity of further evaluation of existing endpoints and the improved characterization of disease endotypes. We also discuss key steps to the development of optimized short- and long-term endpoints that can be linked to meaningful health outcomes. Finally, we discuss the importance of limiting variability in data collection and the application of new clinical trial endpoints as well as the critical nature of multi-stakeholder collaboration to advancing therapeutic development for this vulnerable patient population. |
| Databáze: | OpenAIRE |
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