Journal: bmj: british medical journal / Publication Year Range: Last 3 years / Topic: european medicines agency - Searchworks@Jio Institute Digital Library Search Results

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Start Over Topic european medicines agency Publication Year Range Last 3 years Journal bmj: british medical journal

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1. REPLACING RCTS WITH REAL WORLD DATA FOR REGULATORY DECISION MAKING.

Author: Morales, Daniel R. and Arlett, Peter
Subjects: PROFESSIONAL standards, DRUG efficacy, RANDOMIZED controlled trials, DECISION making in clinical medicine
Published: 2023
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2. Replacing RCTs with real world data for regulatory decision making: a self-fulfilling prophecy?

Author: Wieseler, Beate, Neyt, Mattias, Kaiser, Thomas, Hulstaert, Frank, and Windeler, Jürgen
Subjects: DRUG approval, HEALTH policy, EXPERIMENTAL design, SCIENTIFIC observation, GOVERNMENT regulation, INVESTIGATIONAL drugs, RANDOMIZED controlled trials, GROUP decision making, DRUG development
Published: 2023
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3. Seven days in medicine: 24-30 November 2021.

Subjects: ASSISTED suicide laws, SUICIDE prevention, DRUG efficacy, PRESS, COVID-19, HEALTH services accessibility, HOSPITAL emergency services, COVID-19 vaccines, AWARDS, PLASTIC surgery, HEALTH status indicators, MENTAL health, MARKETING, LABOR supply, EUTHANASIA, PHARMACEUTICAL industry, ALCOHOLS (Chemical class)
Published: 2021
Full Text: View/download PDF

4. Patient reported outcomes are also needed: If regulators use surrogate endpoints to approve drugs, they also have to consider patients' stories.

Author: Wilson, Roger
Subjects: BIOMARKERS, DRUG approval, DRUG efficacy, CLINICAL trials, HEALTH outcome assessment, QUALITY of life
Published: 2021