Q&A document Complex clinical trials gepubliceerd
Op 2 juni 2022 is het document 'Complex clinical trials – Questions and answers, Version 2022-05-23' gepubliceerd.
"This Q&A document provides guidance and seeks to support sponsors, clinical trialists and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT authorisation (CTA), conduct, reporting and transparency, analysis and interpretation of complex clinical trials (CCTs) under the EU Clinical Trials Regulation (EU CTR) as well as their use in submissions for marketing authorisation. It complements and should be used together with relevant EU and ICH guidelines, in particular E6, E8, E9, E10, E16, E19, E11A and E20 (when available)."
bron: pagina 4 (Scope), Questions and answers - Complex clinical trials Version 2022-05-23.
In het Q&A document wordt ingegaan op de volgende vragen:
- Important considerations for the planning and conduct of complex clinical trials
- Which additional considerations are needed for the design and conduct of master protocol studies?
- How to describe and explain Bayesian approaches in complex clinical trials?
- What are the considerations for planning, collection and use of control data from within a complex clinical trial for regulatory purposes?
- Which principles apply, and which regulatory pathways should be considered when using biomarkers and biomarker assays in complex clinical trials and consequently applying for marketing authorisations?
- Safety, rights and well-being of participants
- Transparency (balance with integrity) and communication between regulators, sponsors and investigators