In today’s ACT Brief, we examine how legacy workflows pull community clinics away from patient care, why medical writing capacity depends on training rather than technology, and how an antiviral aims to prevent COVID-19 after exposure
News|Podcasts|October 29, 2026
ACT Brief: Community Trial Access Technology, RBQM Infrastructure, and Digital Clone Use Cases
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we examine why anti-kickback guidance and EHR-integrated trial matching must work together in community settings, why real-time trials depend on mature risk-based quality management, and how pharma is applying digital clones to predict outcomes.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In
part three of a video interview , Kent Thoelke, CEO of Paradigm Health, outlines why anti-kickback guidance and modern EHR-integrated trial matching technology must work in tandem to reach representative patient populations at the community level. Neither can close the gap alone, so the two must be addressed together. - In a
new contributor article , Mohamed Natheem of IQVIA argues that the FDA’s real-time clinical trials initiative transmits predefined, clinically meaningful signals to regulators rather than raw data streams. Its value therefore depends on the maturity of sponsors’ upstream risk-based quality management, including key risk indicators, quality tolerance limits, and root-cause context, rather than on data speed. He concludes that RBQM is the infrastructure real-time trials cannot exist without. - In an
interview with Pharmaceutical Executive , Hamish Brocklebank, founder of Brox.AI, outlines three levels of digital clone use cases in pharma. The simplest level tests thousands of variations of HCP-facing content, while the middle level predicts behaviors such as price sensitivity, using GLP-1 therapies as an example. The most complex level simulates how quickly a cohort of physicians would begin prescribing a drug after FDA approval.
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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In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patients in community and rural settings too often lack access to clinical research as a care option, and how closing that gap could improve outcomes and lower long-term costs.
The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.
In this video interview, Kent Thoelke, CEO of Paradigm Health, outlines why anti-kickback guidance and modern EHR-integrated trial matching technology must work in tandem to reach representative patient populations at the community level.
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