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   Articles with "registration trials" as a keyword



Postrecurrence Treatment in Neoadjuvant or Adjuvant FDA Registration Trials

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recommendations! Published in 2024 at "JAMA Oncology"

DOI: 10.1001/jamaoncol.2024.1569

Abstract: This systematic review examines the proportion and quality of postrecurrence treatment among patients in US Food and Drug Administration (FDA) registration trials of anticancer therapy in the neoadjuvant or adjuvant setting. read more here.

Keywords: fda registration; postrecurrence treatment; neoadjuvant adjuvant; registration trials ... See more keywords

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

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recommendations! Published in 2022 at "Clinical Pharmacology and Therapeutics"

DOI: 10.1002/cpt.2709

Abstract: Medication adherence is a key factor impacting efficacy and safety of medicines, yet how it is dealt with in European registration trials is unknown. A cross‐sectional analysis of European Medicines Agency (EMA) marketing authorization dossiers… read more here.

Keywords: registration trials; adherence; medication adherence; measurement methods ... See more keywords

Racial Diversity and Reporting in United States Food and Drug Administration Registration Trials for Thoracic Malignancies from 2006 to 2020

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recommendations! Published in 2022 at "Cancer Investigation"

DOI: 10.1080/07357907.2022.2131808

Abstract: Abstract There is significant racial disparity in thoracic malignancies in terms of epidemiology and outcomes. We analyzed race reporting and racial diversity in the registration trials of drugs approved by the FDA for thoracic malignancies… read more here.

Keywords: thoracic malignancies; malignancies 2006; registration trials; racial diversity ... See more keywords

Ethnic differences in response to atypical antipsychotics in patients with schizophrenia: individual patient data meta-analysis of randomised placebo-controlled registration trials submitted to the Dutch Medicines Evaluation Board

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recommendations! Published in 2023 at "BJPsych Open"

DOI: 10.1192/bjo.2023.19

Abstract: Background Little is known about the effect of ethnicity on the response to antipsychotic medication in patients with schizophrenia. Aims To determine whether ethnicity moderates the response to antipsychotic medication in patients with schizophrenia, and… read more here.

Keywords: meta analysis; response; patients schizophrenia; registration trials ... See more keywords

Frailty in relapsed/ refractory multiple myeloma registration trials.

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recommendations! Published in 2021 at "Journal of Clinical Oncology"

DOI: 10.1200/jco.2021.39.15_suppl.e20017

Abstract: e20017 Background: Multiple Myeloma (MM) is predominantly a disease of older adults with a median age of onset at 70 years. There is growing interest in using criterion other than chronological age, like frailty, to… read more here.

Keywords: myeloma; frailty; age; index ... See more keywords