EUXCT & EFPIA:2024年临床试验国际化研究报告(英文版)(24页).pdf

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EUXCT & EFPIA:2024年临床试验国际化研究报告(英文版)(24页).pdf

1、REPORTEU-X-CT PUBLIC STAKEHOLDERS FORUM MAKING CROSS-BORDER ACCESSTO CLINICAL TRIALS A REALITYWEBSITEEU-X-CT C/O EFGCP https:/eu-x-ct.eu/eu-x-ctCreated by Oksana Latyshevafrom the Noun ProjectCreated by Oksana Latyshevafrom the Noun ProjectThe pan-European public-private EU-X-CT initiative aims to f

2、acilitate cross-border access to clinical trials.As a first step,we are collecting information on the regulatory,ethical,social security,liability insurance and organisational conditions for the involved stakeholders,as well as experiences and best practices in all European countries.At the Public S

3、takeholders Forum held in Brussels on April 12,2024,the national conditions for patients,clinical investigators,academia/public funders,and industry sponsors needing cross-border participation of patients in clinical trials were reviewed.The EU-X-CT leadership presented the initial results of the EU

4、-X-CT gap analysis.This report summarises key insights from the meeting.INTRODUCTION2Table of ContentAcknowledgements.4Attendees.5Schedule.6Where we are today:Summary of session 1.8 Violetas experience as a caregiver and patient advocate.8 A caregivers and an investigators cross-border clinical tria

5、l experiences .10 Round table:Current experience with cross-border trial participation.11 Keynote:Overcoming borders will make Europe a more attractive place for clinical trials.12 The EU-X-CT gap analysis.13 Panel and Open Forum Discussion I.15Where we are today:Summary of session 2.18 PCM4EU&PRIME

6、-ROSE:Cross-border access to pragmatic precision medicine trials.18 Industry experience with cross-border enrolment in rare diseases.19 The way forward:How to make progress in cross-border access to clinical trials?.20 How can EU-X-CT achieve the most urgent goals and how to make them sustainable?.2

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