We want to share the acknowledgment that APICES has received in ORIGEN study, which is an NSCLC retrospective study, published in the ESMO 2023 congress, in which APICES has collaborated in start-up, project management, monitoring, biostatistics, and medical writing activities.
This recognition is a great motivation for the entire APICES team to continue the commitment we bring to every project we collaborate on. APICES is very proud of the acknowledgment of our work, and we would like to thank the authors and Astrazeneca, for giving us the opportunity to appear in the acknowledgments of the publication. We also congratulate them and all the investigators on the success of their project.
This Retrospective study aims to determine the prevalence of sensitizing EGFR mutations using real-time PCR-based molecular analysis in patients with early-stage nonsquamous NSCLC with stage IA–IIIB disease, who underwent surgical resection in Spain.
You can find further information in the following link: Prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain: the ORIGEN study – Varela – Translational Lung Cancer Research
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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...
EU MDR clinical investigation requirements have fundamentally changed how Medtech sponsors plan and execute device studies in Europe. Regulation (EU) 2017/745 replaced the clinical investigation provisions of Directive 93/42/EEC (MDD) and introduced a more stringent, harmonised framework across all 27 EU member states. For sponsors running investigations in Spain, Germany, France, the Netherlands, or any other member state, understanding which pathway applies to their study is the single most consequential regulatory decision before CIP submission.
