Community participation gaps look less like a question of patient willingness and more like a financing and infrastructure problem that no single bill has yet solved.
News|Articles|April 29, 2011
REMS Challenges Discussed
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In late April, the Center for Business Intelligence (CBI) held a two-day forum on Drug Safety. The focus was REMS, the FDAs enforceable Risk Evaluation and Mitigation Strategy, and included discussions on REMS assessment, challenges, case studies, technology and more.
Applied Clinical Trials Editor Lisa Henderson attended the conference and blogged live. You can read the blogs by clicking the links below.
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In today’s ACT Brief, we examine what changes when AI is embedded across clinical operations, why faster trial data isn’t yet producing faster decisions, and how FDA granted accelerated approval to a therapy for a rare airway disease.
Data capture is no longer the bottleneck, and whether the lag between a signal and a decision shrinks depends on signal design, AI governance, and vendor orchestration.
In this Q&A, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, discusses what changes when AI is embedded across protocol strategy, data infrastructure, and workflow tools at once, where governance frameworks tend to fall short, and why CROs must orchestrate AI ecosystems rather than simply aggregate them.
In today’s ACT Brief, we examine what policy changes would help community and rural institutions join research, how Walmart is expanding clinical trial centers into three more states, and how FDA approved Ilumya for adults with active psoriatic arthritis.
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.
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lack access to research as a care option, what makes AI assistants trustworthy in regulated trials, and how FDA draft guidance could let gene editing therapies cover patient-specific variants.
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