A pooled real-world dataset, 427 cancer patients, and one side effect that can derail pain care. The NALOPOOL analysis puts naloxegol under the spotlight, and APICES contributed as an author and in the statistics.
APICES author in a NALOPOOL study publication
We want to share that APICES is an author and has received acknowledgment in the NALOPOOL study, which is a Real-World Data (RWD) study on opioid-induced constipation in cancer patients, published in Cancers. Moreover, APICES also contributed to the statistical analysisof the study.
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 authorship and the acknowledgment of our work, and we would like to thank Kyowa Kirin International, as well as Dr. Sabaté and Dr. Beato-Zambrano, for giving us the opportunity to be part of the authorship and appear in the acknowledgments of the publication. We also congratulate them and all the investigators on the success of their project.
This Real-World Data (RWD) study evaluates the effectiveness and safety of naloxegol in treating opioid-induced constipation (OIC) among cancer patients, analyzing data from multiple sites and focusing on patient-reported outcomes and clinical efficacy.
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.