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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.

Credit: Valerii Apetroaiei | stock.adobe.com

Topline results from the Phase III DESTINY-Breast11 trial show that Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab, and pertuzumab significantly improves pathologic complete response rates compared to anthracycline-based standard-of-care regimens in the neoadjuvant treatment of high-risk, locally advanced HER2-positive early-stage breast cancer.