In today’s ACT Brief, we examine why APAC is attractive for global Phase III programs, how clinical research professionals can turn a failed pivotal trial into a redesigned success, and how FDA approved Sunharbo to reduce recurrent stroke risk.
News|Podcasts|November 12, 2026
ACT Brief: APAC Sponsor Priorities, Continuous Glucose Monitoring Trials, and GLP-1 Eye Warning
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we examine three priorities for first-time APAC sponsors, how continuous glucose monitoring should be used in diabetes trials, and why FDA is requiring a new eye-related warning across GLP-1 medications.
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- In
part five of a video interview , James Cheong, senior vice president of Asia Pacific at Precision for Medicine, shares three priorities for first-time APAC sponsors. He says they should align with marketing authorization plans, select the right sites, and choose a CRO with regional experience and KOL networks. - In a
new contributed article , Réka Balogh and Brian Rundle of Clario, part of Thermo Fisher Scientific, explain how FDA and EMA expectations shape the use of continuous glucose monitoring in diabetes trials. They advise sponsors to provision blinded study devices to all participants, since real-time glucose visibility can change behavior and bias outcomes. The article also stresses consistent device models and validated data systems that meet data integrity standards. FDA is requiring manufacturers of all GLP-1 medications to add a warning about a potential increased risk of a rare eye condition that can cause sudden vision loss in one eye. FDA’s meta-analysis of 126 randomized trials covering 134,253 patients identified 15 probable cases, 10 in patients treated with GLP-1 medications and 5 on placebo. The incidence was 6.4 cases per 100,000 person-years among GLP-1 users, compared with 3.8 among comparator-treated patients.
That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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