ACT Brief: Digital Consent, Global Diversity, and Clinical Setbacks Shape Today’s Clinical Research Landscape

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert perspectives, and keep you current on what’s moving the industry. Let’s get into it.

On today’s episode, we’re covering the expanding role of digital consent in decentralized trials, new insights on diversity in global breast cancer research, and a major mRNA program shift at Moderna.

We begin with how eConsent is transforming the clinical trial experience for both patients and sites. As decentralized and hybrid models expand, digital consent tools are helping replace paper-based forms with multimedia explanations, automated checks, and secure data management. According to the author of this new article, these platforms not only strengthen compliance and engagement across demographics—they also cut administrative workload and reduce protocol deviations. With regulators now endorsing eConsent adoption, it’s becoming a core capability for patient-centric and globally scalable studies.

Next, a new video interview highlighted encouraging signs of greater international participation in global breast cancer trials, while acknowledging that challenges persist. A new industry analysis found that nearly half of top trial leaders are still based in the US or China. There is progress, however, as more investigators emerge from Europe and Asia. The interviewee emphasized that AI and machine learning can help close equity gaps by identifying new sites, supporting local investigators, and redistributing workloads to underserved regions—paving the way for more globally representative research.

Finally, over on Pharmaceutical Executive, Moderna has announced it will discontinue development of its mRNA-1647 vaccine after the candidate failed to meet its primary goal in a Phase III trial. The vaccine was designed to prevent cytomegalovirus infection in seronegative women of childbearing age, a major unmet need in preventing congenital CMV. Despite the setback, Moderna leadership said the company will continue exploring mRNA-1647’s potential for treating reactivation in high-risk patients and will maintain its focus on oncology and respiratory programs moving forward.

That’s all for today’s ACT Brief. Join us next week for more insights shaping the future of clinical operations and drug development. Thanks for listening.