ACT EU aims to facilitate activities on methodological aspects for clinical trials.
In order to reach this goal, the objectives of the work are to:
- ensure aligned clinical trial guidance development across the European network resulting in high impact guidance documents implemented in practice;
- bring together key decision makers during the clinical trial life cycle via sustainable coordination of guidance development;
- help stakeholders navigate the EU clinical trial guidance landscape;
- organise dedicated workshops on topics of interest.
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 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.
Roadmap of methodology guidance on clinical trials
Under ACT EU, regulatory expert groups working on clinical trial methodology are collaborating closely to deliver guidance on high-impact topics.
The roadmap illustrates the planned collaboration on guidance expected in the next few years.
Overview of methodology guidance on clinical trials
This section provides an overview of EU regulatory guidance on clinical trial methodology.
European Medicines Agency
- 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
Clinical Trials Coordination 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
Clinical Trials Coordination and Advisory Group
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
Health Technology Assessment
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 (DCTs)
In DCTs, some or all of a clinical trial’s activities occur at locations other than a traditional clinical trial site, including the participant’s home, a local health care facility, or a nearby laboratory. DCTs aim to reduce the barriers to clinical trial participation for patients, thereby improving recruitment and retention, and targeting a wider demographic of participants.
For more information, see:
- EMA website: Guidance for decentralised clinical trials
- EMA website: Facilitating decentralised clinical trials in the EU
Complex clinical trials
Guidance is available for clinical trial sponsors, clinicians engaged in clinical trials and marketing authorisation applicants on planning and conducting complex clinical trials:
- EMA website: Guidance for complex clinical trials
- HMA website: CTCG Q&A on submission complex clinical trials in CTIS
Additional topics
News
The ACT EU workplan for 2026-2027 outlines the initiative's revised objectives and areas of focus, informed by feedback from stakeholders.
Following consultation with the Multi-stakeholder platform Advisory Group, new documents have been published to support sponsors in the implementation of the Clinical Trials Regulation (CTR).
The ACT EU workplan for 2025-2026 outlines the initiative's areas of focus, which reflect feedback from stakeholders.
