APICES acknowledged for its role in the GGCP 081/21 Study
How does first-line osimertinib perform for advanced EGFR-mutated NSCLC in routine care in Spain? The GGCP 081/21 retrospective study addresses effectiveness and safety in a real-world setting, and APICES was acknowledged for supporting analysis and publication activities.
APICES acknowledged for its role in the GGCP 081/21 Study
We are proud to announce that APICES has been acknowledged for its ongoing collaboration in the GGCP 081/21 study, an Observational retrospective study in Lung Cancer (NSCLC). This acknowledgement was highlighted in the Journal of Clinical and Translational Oncology.
This acknowledgment is a great motivation for the entire APICES team to continue the commitment we bring to every project we collaborate on. We sincerely thank Astrazeneca Spain and Dra. Maria Carmen Areses Manrique for giving us the opportunity to support the study as CRO and for including us acknowledgments. We also congratulate them and all investigators and patients on the GGCP 081/21 Study progress and results.
The GGCP 081/21 study aims to evaluate the effectiveness and safety of osimertinib as a first-line therapy in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) in a Spanish real-world setting.
Key Takeaways: First-in-human trials in the EU are governed by Regulation (EU) No 536/2014 and the EMA’s first-in-human guideline (EMEA/CHMP/SWP/28367/07 Rev 1). Sponsors must submit a complete Clinical Trial Application via the CTIS portal and obtain both Part I...
Key Takeaways: Phase I dose escalation design in the EU is governed by ICH E8(R1), EMA first-in-human guidance (EMA/CHMP/SWP/28367/07 Rev.1), and EU Clinical Trial Regulation 536/2014 via CTIS. The classical 3+3 design is increasingly replaced by model-based...
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