On May 20, 2022, a set of Key Performance Indicators (KPIs) to monitor the European clinical trials environment were published to coincide with International Clinical Trials Day, a key date to celebrate the progress achieved in the area of clinical trials and those who make clinical research possible.
The creation and publication of the KPIs is a priority action of the Accelerating Clinical Trials in the EU (ACT EU) program, a joint initiative of the Heads of Medicines Agencies (HMA), the European Commission and EMA to transform the EU clinical trials environment.
The KPIs will be published monthly on the EMA website, pulling information from the two EU clinical trials databases, EudraCT and CTIS. The KPIs measure the number of clinical trial applications submitted under the Clinical Trial Regulation via CTIS and under the Clinical Trials Directive via EudraCT. They also include data on the number of authorized trials that are mono-national and multi-national, commercial and non-commercial, and the number of trials per trial phase and therapeutic area.
On June 2, 2022, a Q&A on complex clinical trials was published as part of the ACT EU priority action on developing and publishing guidance on key methodologies. This priority action aims to provide guidance on innovative tools and methods for clinical trials, strengthening the links between innovation and scientific advice.
The Q&A on complex trials covers topics such as key considerations for the planning and conduct of complex clinical trials, and for the planning and conduct of master protocols.
Read the official guidelines here.
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