ACT EU aims to facilitate aligned clinical trial guidance development across the European network resulting in high impact guidance documents implemented in practice.
In order to reach this goal, the objectives of the work will be to:
- ensure mutual awareness of our guidance landscape across European Union (EU) expert groups;
- ensure involvement of all relevant stakeholders at the right time to facilitate alignment, consolidation and implementation of methodology guidance;
- bring together clinical trial authorisation by Member States and down-stream decision makers;
- help our stakeholders navigate the EU clinical trial guidance landscape;
- ensure capturing and sharing of lessons learned.
These objectives ensure that all relevant EU expert groups pool their expertise and align their priorities in order to accelerate the development of future guidance, in collaboration with relevant stakeholders.
Direct deliverables to fulfil these objectives will include:
- a roadmap to clarify the guidance landscape with an overview of the existing, ongoing and planned key guidance activities;
- a methodology workshop to facilitate alignment, consolidation and accelerate guidance development;
- internal best practice on how to develop guidance documents and ensure implementation;
- internal process for coordination of guidance development to ensure sustainable coordination of methodology guidance development.
Overview of methodology guidance on clinical trials
This section provides an overview of EU regulatory guidance on clinical trial methodology.
- General overview of all clinical efficacy and safety guidelines: EMA website: Clinical efficacy and safety guidelines
- Biostatistics: EMA website: Biostatistics
- Real-world evidence and registry-based studies: EMA website: Real-world evidence
- Multidisciplinary guidelines, including paediatric development and Artificial Intelligence: EMA website: Multidisciplinary guidelines
- Good Clinical Practice (GCP) inspector’s working group: EMA website: Good Clinical Practice Inspectors Working Group
Overview of guidance documents with regard to authorisation and supervision of clinical trials, including complex clinical trials, safety reporting, contraception/pregnancy testing, Good Laboratory Practice and recommendations for the intersection of Clinical Trials Regulation and the In-vitro Diagnostic Regulation.
Heads of Medicines Agencies: Clinical Trials Coordination Group, see key documents list
Overview on documents applicable to authorisation and conduct clinical trials under Regulation EU No 536/2014, support to the implementation of the clinical trial as well as relevant frameworks for clinical trials, e.g. risk proportionate clinical trials, complex clinical trials and decentralised elements in clinical trials.
European Commission: EudraLex - Volume 10 - Clinical trials guidelines
Overview of procedural and scientific guidance on Health Technology Assessment (HTA), including guidance on the validity of different types of studies to answer HTA research questions, on study outcomes required for HTA and on methods of evidence synthesis for HTA.
European Commission: Health technology assessment - Key documents
Related material
Decentralised clinical trials
- EMA website: Guidance for decentralised clinical trials
- EMA website: Facilitating decentralised clinical trials in the EU
Complex clinical trials
- EMA website: Guidance for complex clinical trials
- HMA website: CTCG Q&A on submission complex clinical trials in CTIS
Additional topics
