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Oral Poster Session 6 - Clinical Development & Pharmacovigilance Content Hub
Learning Objective : The aim of this meta-epidemiological (ME) study is to give an overview of single-arm studies (SaS) provided as ultimate proof of treatment efficacy for authority approval, to highlight weakness and potential sources of biases of this type of clinical trials (CT).
Speaker(s)
Could we do without RCTs? The emergence of single-arm studies as a basis for approval, a meta epidemiologic study
Theo Blaise, MPharm
Universite Claude Bernard Lyon , France
Pharmacy resident - Master degree
ClinLine.ru – the first Russian clinical trial platform for Patients, Investigators, Sponsors and CRO
Oksana Karavaeva, MD
IPHARMA LLC, Russian Federation
ClinOps Director
Quality Assessment of Published Pharmacogenetic Association in Randomized Clinical Trials, a Systematic Review
Julie Quemeneur, MSc
Claude Bernard University Lyon 1, France
Pharmacy and Master 2 Clinical Evaluation Student
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