All Clinical Trials articles
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Industry newsMHRA cuts approval times for UK clinical trials in half
This industry news update announces the MHRA’s decision to reduce clinical trial approvals from 91 days to 41 days.
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JournalNavigating the landscape of paediatric clinical trials under US FDA guidelines
This article explores paediatric clinical trials under the guidelines of US Food and Drug Administration (FDA) legislation, focusing on research development and ethics.
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JournalDiversity in clinical research: Regulatory considerations and updates
This article explores how to improve diversity and patient representation in clinical trials and looks at guidance from the EMA.
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JournalRealising opportunities to generate RWE for regulatory decisions through randomised pragmatic trials
This article summarises key features of the EFPIA paper and discusses how randomised pragmatic trials can be used to aid regulatory decision-making.
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JournalThe importance of patient advocacy in the EMA ODD process
This article discusses the role of patient advocacy groups in the orphan drug designation process to incoporate more patient-centred approaches.
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Industry newsNHS app opens access to trials for UK patients
This industry news update looks at the NHS app and the opportunities for patients to take part in clinical trials.
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JournalClinical trial design – keeping up with innovation
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract A well-designed clinical trial is essential for the collection of reliable, robust and meaningful data to ensure the protection of participants rights and safety and also minimise economic losses ...
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JournalNavigating the regulatory terrain down under: trends in Australia for 2024
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Introduction Australia is the most populous country in Oceania, and ranks 55th globally with its population around 26 million. It also ranks consistently high in other indicators that demonstrate the ...
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Industry newsScientists hail gram-negative-bacteria killing antibiotic
A novel class of antibiotic has been discovered that is effective against the extensive drug-resistant, gram-negative bacteria, Crab.