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Clarifying Ownership of IRT Data in Clinical Trials: Distinguishing Investigator-Controlled Data from Sponsor Operational Data

Measuring Barriers to Improve Enrollment and Retention

ACT Brief: Support Services and Cancer Trial Access, 2025’s Most-Watched ACT Video Interviews, and FDA Approval of Narsoplimab

Our Top 5 Most Viewed Video Interviews in 2025

Precision Matching Meets Practical Support

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Examine how the American Cancer Society’s national ACTS expansion is designed to simplify trial discovery, reduce logistical barriers, and help patients, caregivers, and providers navigate cancer clinical trials through a centralized support model.

Generative AI adoption, regulatory scrutiny, DEI policy shifts, real-world evidence, and rare disease economics emerged as key themes across these most-read Applied Clinical Trials articles shaping clinical research and drug development today.

Persistent recruitment delays, high dropout rates, and missed timelines continue to slow global clinical trials, while data show that sub-Saharan Africa offers a largely untapped opportunity with established research capacity, large patient pools, and strong enrollment and retention performance.

In today’s ACT Brief, we cover the FDA approval of oral Wegovy based on Phase III OASIS 4 results, recap the most-read Applied Clinical Trials articles of 2025, and examine why data quality remains critical to enabling AI in clinical trials.

The FDA approval of oral semaglutide marks the first GLP-1 pill for chronic weight management, supported by Phase III OASIS 4 data demonstrating substantial weight loss, favorable safety, and improvements in cardiometabolic risk factors.

Review the performance, engagement, and satisfaction metrics sponsors and CROs should track to determine whether operational improvements are reducing burden and strengthening site relationships.

In today’s ACT Brief, we look at how AI-enabled workflows can automate existing site processes, review the FDA approval of subcutaneous Lunsumio VELO for relapsed or refractory follicular lymphoma, and examine early clinical development activity for a pan-KRAS inhibitor licensed by AstraZeneca.

The FDA has cleared subcutaneous mosunetuzumab for adults with relapsed or refractory follicular lymphoma after two or more prior therapies, supported by Phase I/II data showing durable responses and a manageable safety profile with markedly reduced administration time.

Learn how AI-enabled automation can streamline existing operational processes, reduce manual effort, and enhance efficiency while allowing sites to work as they do today.

In today’s ACT Brief, we examine why fragmented data systems continue to slow life sciences research, review how sponsor sourcing decisions may affect site experience and study execution, and report on topline Phase III results for Eli Lilly’s oral GLP-1 therapy orforglipron.

Only with recent advances in cloud computing, data standards, and interoperable platforms has it become feasible to realize the full potential of a digital thread.

Analyze how functional sourcing, application strategy, and consistency across sponsors and CROs directly influence site workflows, execution efficiency, and long-term collaboration.

In today’s ACT Brief, we examine how sponsors are reassessing new engagement technologies to avoid increasing site burden, review new research on integrating unstructured health data to scale eSource-enabled trials, and cover Novo Nordisk’s NDA submission for its fixed-dose amylin–GLP-1 obesity therapy, CagriSema.

New research finds that while eSource adoption is advancing through EHR-to-EDC workflows, scaling its impact will depend on integrating unstructured clinical data using AI, shared standards, and collaborative validation models across sites, sponsors, and vendors.

Explore why new tools should aim to remain burden-neutral before delivering efficiency gains, and how sponsors can introduce systems that benefit sites without disrupting daily trial management.






















