Developing generic templates to shape the future for conducting integrated research platform trials

Developing generic templates to shape the future for conducting integrated research platform trials

Abstract Background Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Practice—scientific guideline, first published in 2002 and last updated i...

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Main Authors: Madhavi Gidh-Jain, Tom Parke, Franz König, Cecile Spiertz, Peter Mesenbrink, On behalf of EU-PEARL (Europe [EU] Patient-cEntric clinicAl tRial pLatforms) an Innovative Medicines Initiative (IMI) initiative Work Package 2 (WP 2)
Format: Article
Language:English
Published: BMC 2024-03-01
Series:Trials
Subjects:
Master Protocol Template
Integrated research platform trials
EU Patient-cEntric clinicAl tRial pLatforms
Online Access:https://doi.org/10.1186/s13063-024-08034-8

Internet

https://doi.org/10.1186/s13063-024-08034-8

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