International regulators provide guiding principles for COVID-19 clinical trials

1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...

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Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines

24 June 2020 - Under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators discussed COVID-19 vaccine ...

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First drug proves able to improve survival from COVID-19, trial shows

17 June 2020 - A low-cost, widely used anti-inflammatory drug has improved survival in patients with COVID-19, scientists say, the ...

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EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...

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EMA calls for high-quality observational research in context of COVID-19

26 May 2020 - For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, ...

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International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials

15 May 2020 - Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of ...

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Human trials to begin on COVID-19 vaccine by Thursday

21 April 2020 - A million doses of their experimental coronavirus vaccine could be ready as early as September, Oxford scientists ...

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EMA shares advice on validated computer systems used in clinical trials

16 April 2020 - The EMA has published a notice about validating and qualifying all types of computerised systems used ...

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Global regulators stress need for robust evidence on COVID-19 treatments

9 April 2020 - International regulators have published a report today highlighting their considerations on the development of potential COVID-19 ...

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Global regulators map out data requirements for phase 1 COVID-19 vaccine trials

24 March 2020 - Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...

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Beyond “Intent‐to‐treat” and “Per protocol”: improving assessment of treatment effects in clinical trials through the specification of an estimand

27 December 2019 - There is a key problem in randomised clinical trials as outcomes can be distorted due to ...

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Call for all sponsors to publish clinical trial results in EU database

3 July 2019 - The European Commission, the European Medicines Agency and the Heads of Medicines Agencies have co-signed a ...

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The evolution of adaptiveness: balancing speed and evidence

29 November 2018 - 'Adaptive' approaches to bringing drugs to market have been widely discussed in recent years.  ...

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Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

12 September 2018 - Following the 2012 EC guideline, sponsors must ensure that all trials registered on EUCTR since 2004 disclose ...

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MHRA clarifies post-Brexit clinical trials rules

8 August 2018 - The MHRA has clarified how the UK’s clinical trials rules will function in partnership with the ...

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