Cargando…

A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020

INTRODUCTION: Cancer and corresponding available treatments are associated with substantial symptoms and functional limitations. In this context, collection of patient-reported outcomes (PRO) in clinical trials gained special interest and is recommended by regulatory authorities. Within clinical tri...

Descripción completa

Detalles Bibliográficos
Autores principales:	Teixeira, Maria Manuel, Borges, Fábio Cardoso, Ferreira, Paula Sousa, Rocha, João, Sepodes, Bruno, Torre, Carla
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Frontiers Media S.A. 2022
Materias:	Medicine
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9411861/ https://www.ncbi.nlm.nih.gov/pubmed/36035431 http://dx.doi.org/10.3389/fmed.2022.968272

Ejemplares similares

Predictors of orphan drug approval in the European Union
por: Heemstra, Harald E., et al.
Publicado: (2008)

Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan
por: Yano, Kazuo, et al.
Publicado: (2014)

Approval and Certification of Ophthalmic AI Devices in the European Union
por: Grzybowski, Andrzej, et al.
Publicado: (2023)

Evolving prevalence of haematological malignancies in orphan designation procedures in the European Union
por: Polsinelli, Benedetta, et al.
Publicado: (2017)

Patient-Reported Outcome Measures in Oncology Drugs Approved by the European Medicines Agency, 2017-2021
por: Ciani, Oriana, et al.
Publicado: (2023)

Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non‐orphan, Non‐oncology Drugs in the European Union and United States from 2012−2016
por: Morant, Anne Vinther, et al.
Publicado: (2019)

Establishing medical plausibility in the context of orphan medicines designation in the European Union
por: Tsigkos, Stelios, et al.
Publicado: (2014)

Cell-based medicinal products approved in the European Union: current evidence and perspectives
por: Bellino, Stefania, et al.
Publicado: (2023)

The 2017 European Union report on pesticide residues in food
Publicado: (2019)

Erratum to: Establishing medical plausibility in the context of orphan medicines designation in the European Union
por: Tsigkos, Stelios, et al.
Publicado: (2015)

Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework
por: Carvalho, Marta, et al.
Publicado: (2017)

The 2020 European Union report on pesticide residues in food
por: Carrasco Cabrera, Luis, et al.
Publicado: (2022)

The European Union One Health 2020 Zoonoses Report
Publicado: (2021)

Navigating the maze of requirements for obtaining approval of non-interventional studies (NIS) in the European Union
por: Ramirez, Isabelle
Publicado: (2015)

Engineered Microorganisms for the Production of Food Additives Approved by the European Union—A Systematic Analysis
por: Kallscheuer, Nicolai
Publicado: (2018)

Consumption of cephalosporins in the community, European Union/European Economic Area, 1997–2017
por: Versporten, Ann, et al.
Publicado: (2021)

Consumption of quinolones in the community, European Union/European Economic Area, 1997–2017
por: Adriaenssens, Niels, et al.
Publicado: (2021)

Consumption of penicillins in the community, European Union/European Economic Area, 1997–2017
por: Bruyndonckx, Robin, et al.
Publicado: (2021)

Consumption of antibiotics in the community, European Union/European Economic Area, 1997–2017
por: Bruyndonckx, Robin, et al.
Publicado: (2021)

Treatment Advances in Sepsis and Septic Shock: Modulating Pro- and Anti-Inflammatory Mechanisms
por: Marques, Adriana, et al.
Publicado: (2023)

Oncology approvals in 2020: a year of firsts in the midst of a pandemic
por: Amiri-Kordestani, Laleh, et al.
Publicado: (2021)

Use of biomarkers in the context of orphan medicines designation in the European Union
por: Tsigkos, Stelios, et al.
Publicado: (2014)

European Society for Medical Oncology 2020
por: Bartsch, Rupert
Publicado: (2021)

Changes in sedentary behaviour in European Union adults between 2002 and 2017
por: López-Valenciano, A., et al.
Publicado: (2020)

Medication Adherence Measurement Methods in Registration Trials Supporting the Approval of New Medicines: A Cross‐Sectional Analysis of Centralized Procedures in the European Union 2010–2020
por: Mantila, Katerina M., et al.
Publicado: (2022)

Change-points in antibiotic consumption in the community, European Union/European Economic Area, 1997–2017
por: Bruyndonckx, Robin, et al.
Publicado: (2021)

Consumption of macrolides, lincosamides and streptogramins in the community, European Union/European Economic Area, 1997–2017
por: Adriaenssens, Niels, et al.
Publicado: (2021)

Quality appraisal of antibiotic consumption in the community, European Union/European Economic Area, 2009 and 2017
por: Adriaenssens, Niels, et al.
Publicado: (2021)

COVID-19 treatments approved in the European Union and clinical recommendations for the management of non-hospitalized and hospitalized patients
por: Bellino, Stefania
Publicado: (2022)

Public Health Policies in European Union: An Innovation Strategy—Horizon 2020
por: Soulis, Sotiris, et al.
Publicado: (2015)

Leishmaniases in the European Union and Neighboring Countries
por: Berriatua, Eduardo, et al.
Publicado: (2021)

Implementation and Access to Pre-exposure Prophylaxis for Human Immunodeficiency Virus by Men Who Have Sex With Men in Europe
por: Sepodes, Bruno, et al.
Publicado: (2021)

Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union
por: Jokura, Yoji, et al.
Publicado: (2017)

Navigating Market Authorization: The Path Holoclar Took to Become the First Stem Cell Product Approved in the European Union
por: Pellegrini, Graziella, et al.
Publicado: (2017)

Consumers' acceptance of the first novel insect food approved in the European Union: Predictors of yellow mealworm chips consumption
por: Petrescu‐Mag, Ruxandra Malina, et al.
Publicado: (2022)

Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
por: Hwang, Thomas J., et al.
Publicado: (2022)

Towards a taxonomically unbiased European Union biodiversity strategy for 2030
por: Mammola, Stefano, et al.
Publicado: (2020)

A Regulatory Take on Cannabis and Cannabinoids for Medicinal use in the European Union
por: Lipnik-Štangelj, Metoda, et al.
Publicado: (2020)

Demographic Composition of Select Oncologic New Molecular Entities Approved by the FDA Between 2008 and 2017
por: Ramamoorthy, Anuradha, et al.
Publicado: (2018)

Open government data portals in the European Union: A dataset from 2015 to 2017
por: de Juana-Espinosa, Susana, et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_ct2nckck5t1t8urd0cki5gvnbs