Importance of DCTs Moving Forward

A new global report finds that clinical research teams are making progress but still lack the skills and tools needed to keep pace with growing trial complexity and emerging technologies.

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.

Results from the Phase III FORTITUDE-101 trial showed that bemarituzumab combined with chemotherapy demonstrated both statistical significance and clinical relevance in previously untreated patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer who are FGFR2b-positive and HER2-negative.

At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.

In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.

As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.