A real-time dashboard of clinical trials for COVID-19

In response to the global coronavirus disease 2019 (COVID-19) emergency, clinical trial research assessing the efficacy and safety of clinical candidate interventions to treat COVID-19 are emerging at an unprecedented rate. As of April 21, 2020, well over 500 clinical trials have been registered at the various international and national clinical trial registry sites.  Most

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Court of Justice upholds EMA’s approach to transparency

EMA welcomes today’s two appellate judgments by the Court of Justice1 that confirmed, in clear and unambiguous terms, the right of citizens for access to clinical study and toxicology reports submitted to EMA for the purpose of the granting of a marketing authorisation for human and veterinary medicinal products. Source EMA “Transparency is an important feature of the Agency’s

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European Commission publishes new documents regarding the Clinical Trials Regulation

Shortly after updating the related draft Questions and Answers document, the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form. 2. Recruitment and Informed consent procedure template This draft template was developed

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