A Clinical Research Reality: Standardization of R&D Outsourcing

Results from the Phase Ib/II CARTITUDE-1 trial demonstrated that a single infusion of Carvykti delivered durable, treatment-free remissions for at least five years in a third of patients with relapsed or refractory multiple myeloma.

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.

Despite positive results from a Phase I/II trial of its investigational pandemic influenza vaccine, mRNA-1018, Moderna’s award for almost $600 million to accelerate vaccine development will be terminated.

In the Phase III IMforte trial, Tecentriq (atezolizumab) and Zepzelca (lurbinectedin) reduced the risk of disease progression or death by 46% as a first-line maintenance therapy for patients with extensive-stage small cell lung cancer.

Phase III data presented at ASCO 2025 and published in The New England Journal of Medicine show that Pfizer’s Braftovi (encorafenib), combined with Erbitux (cetuximab) and mFOLFOX6, significantly improves overall survival and progression-free survival in treatment-naïve patients with BRAF V600E-mutant metastatic colorectal cancer—potentially establishing a new first-line standard-of-care for this high-risk population.