In today’s ACT Brief, we look at why durable signal closure is emerging as a defining metric in risk-based quality management, how AI can reduce startup delays without burdening sites, and how patient-centric drug design is reshaping the CDMO landscape.
A new Applied Clinical Trials contributed analysis of more than 880 clinical trials shows that durability—not speed—is the key differentiator in effective signal management under risk-based quality frameworks. While statistical data monitoring and key risk indicator signals close on similar timelines, SDM signals are far less likely to be reopened. The findings reinforce growing regulatory expectations under ICH E6(R3) for defensible, evidence-based signal closure across the trial lifecycle.
In part 3 of a video interview with Applied Clinical Trials, Brian Mallon of ICON says AI and automation can help address persistent startup delays when applied to reduce administrative burden rather than add complexity. He points to contract tools that surface previously agreed language as practical examples of site-friendly innovation. Mallon emphasizes that operational technology must ultimately serve investigators and patients, preserving the human core of clinical research.
In a PharmTechQ&A, Dr. Asma Patel of Quotient Sciences says the rise of patient-centric drug formulations is driving greater reliance on CDMOs with specialized scientific and manufacturing capabilities. Patel explains that advanced modalities and personalized dosing needs are pushing CDMOs earlier into development, particularly for rare and orphan drugs. As a result, CDMOs are increasingly acting as strategic partners across formulation, scale-up, and regulatory readiness.
In today’s ACT Brief, we examine why community and rural patients lack access to research as a care option, what makes AI assistants trustworthy in regulated trials, and how FDA draft guidance could let gene editing therapies cover patient-specific variants.
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.
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
In today’s ACT Brief, we examine how cost barriers and site infrastructure limit participation in community trials, why endpoints should reflect what patients actually experience, and how the FDA expanded a prostate cancer combination to an earlier treatment setting.
In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
In today’s ACT Brief, we examine how AI is moving into continuous clinical operating models, how trust is built into oncology real-world evidence, and how the FDA approved a self-administered option for thyroid eye disease.
The planned sites in Livonia, Las Vegas, and San Antonio would expand a partnership that places clinical research and health screenings inside Walmart stores.
In this video interview, Kent Thoelke, CEO of Paradigm Health, calls for safe harbor protections, CMS reimbursement safeguards, and funding mechanisms modeled on EHR meaningful use to help community and rural institutions participate in research on par with academic centers.
