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Strategies for sponsors in navigating the European Union's new health technology assessment regulation.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Overcoming the illusion of knowledge in clinical research can enhance decision-making, training, and project success—helping ensure trials run smoothly and effectively.

In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.

Phase III DeLLphi-304 results show T-cell engager Imdelltra (tarlatamab) delivers superior overall survival, improved progression-free survival, and better symptom control compared to chemotherapy in patients with small-cell lung cancer following platinum-based treatment.