Blog
RSS FeedPosted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 real-world evidence and observational studies
31 July 2020 - Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main ...
Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable outcomes for clinical trials
31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the ...
Posted by Michael Wonder on 09 Jul 2020
International regulators align positions on phase 3 COVID-19 vaccine trials
9 July 2020 - Medicines regulatory authorities from around the world have published a report today highlighting the outcomes ...
Posted by Michael Wonder on 01 Jul 2020
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 ...
Posted by Michael Wonder on 24 Jun 2020
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 ...
Posted by Michael Wonder on 16 Jun 2020
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 ...
Posted by Michael Wonder on 03 Jun 2020
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 ...
Posted by Michael Wonder on 26 May 2020
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, ...
Posted by Michael Wonder on 15 May 2020
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 ...
Posted by Michael Wonder on 21 Apr 2020
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 ...
Posted by Michael Wonder on 16 Apr 2020
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 ...
Posted by Michael Wonder on 09 Apr 2020
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 ...
Posted by Michael Wonder on 24 Mar 2020
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 ...
Posted by Michael Wonder on 05 Jan 2020
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 ...
Posted by Michael Wonder on 03 Jul 2019
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 ...