In today’s ACT Brief, we examine how ZIP code shapes trial availability and enrollment, why smaller biotechs hold outdated views of APAC sites, and how FDA approved Pimjetmi for symptomatic tenosynovial giant cell tumor.
News|Articles|April 5, 2024
Digital biomarkers show early clinical validity and provide greater confidence in Movement Disorder clinical trials
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Digital biomarkers, smartphones, and wearables are transforming clinical trials by revolutionizing remote data collection and providing insights into treatment efficacy. Learn more about these exploratory endpoints and how they provide greater confidence in a clinical trial.
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In this video interview, Shaalan Beg, MD, MBA, FASCO, chief medical officer at ConcertAI, explains why trial availability, shaped heavily by zip code, is the biggest barrier to enrollment and how access patterns mirror broader healthcare disparities.
In this Q&A, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, discusses why outdated perceptions of APAC sites persist among smaller biotechs, how China’s regulatory reforms have reshaped Phase III startup timelines, and what first-time sponsors need to get right in the region.
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.
In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, shares three priorities for first-time APAC sponsors: aligning with marketing authorization plans, selecting the right sites, and choosing a CRO with regional experience and KOL networks.
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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.
A pivotal trial that missed its primary endpoint became the basis for a successful redesign after the team used the data to define the high-risk patients most likely to benefit, showing that setbacks can strengthen development when organizations interrogate the evidence rather than abandon it.
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