WP2 – Scientific, Regulatory and Operational Methodology
EU-PEARL has developed this comprehensive glossary of terms with the objective of educating people and building knwoledge around complex clinical trials. The document draws on external definitions from authoritative sources to propose a common use of terminology beyond the project’s scope. But the deliverable takes a step further and offers a wide range of materials (beyond terminology) to better understand the relevance and scope of master protocols and platform trials.
Read or download EU-PEARL Report on Terminology and Scenarios for Platform Trials and Masterprotocols (D2.1)
WP2 – Scientific, Regulatory and Operational Methodology
As new complex, innovative designs such as platform trials emerge, clinical operations best practices need to be reviewed to address the new challenges they bring. Clarity on roles and responsibilities, effective resource planning, a sound governance structure, a strategic approach to vendor management and robust training for all key stakeholders are some of the topics which need to be taken into account for multi-sourced, multi-company platform trials to work.
Read or download EU-PEARL Clinical Operations Best Practices Report (D2.2)
Project – EU-PEARL 1st Technical Report: Milestones, deliverables and major achievements
In its first year, EU-PEARL has focused on laying a foundation for the creation of generic and disease-specific IRP frameworks and common tools, while generating awareness on the project and the advantages of adaptive platform trials. Besides developing generic “data management and governance” guidelines, a comprehensive glossary with key terminology and a report on best practices in platform trial operational aspects, disease-specific teams, in collaboration with expert methodologists, have started to address trial design challenges and master protocol development in each of the four disease areas. EU-PEARL also organised 4 successful online Stakeholder Workshop sessions on October’20 focused on: regulatory & ethical issues, methodological challenges and patient engagement priorities for IRP development.
Read or download EU-PEARL_PR01_Technical report_PUBLISHABLE_SUMMARY