Regulatory

The Supreme Court has ruled 5-4 to allow the Trump administration’s NIH funding cuts to continue, impacting more than 1,700 medical research grants in areas including heart disease, HIV/AIDS, Alzheimer’s disease, and mental health.

In this episode of the Applied Clinical Trials Brief, we spotlight a recent video interview in which Jon Walsh, founder and chief scientific officer of Unlearn.AI, shared how digital twins can improve trial efficiency, enhance patient-centric designs, align with regulatory expectations, and accelerate access to new therapies.

In this episode of the Applied Clinical Trials Brief, we spotlight a recent video interview in which Jon Walsh, founder and chief scientific officer of Unlearn.AI, shared how digital twins can improve trial efficiency, enhance patient-centric designs, align with regulatory expectations, and accelerate access to new therapies.

With approval to proceed, the Phase II trial (NCT06092034) of RP-A501 for Danon disease restarts under an optimized dosing and immunomodulatory strategy.

An overview of how recent funding reductions are reshaping clinical trial operations, from site sustainability and patient recruitment to trial design and long-term strategy.

Breakthrough Therapy Designation was based on results from the Phase II IDeate-Lung01 trial (NCT05280470), which demonstrated clinically meaningful benefits in patients with extensive-stage small cell lung cancer treated with ifinatamab deruxtecan.

Ron Lanton, partner, Lanton Law, explains how shifts in policy and government guidance could reduce public participation and complicate the design and recruitment of future vaccine trials.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, shares practical ways clinical teams can strengthen trial protocols for expedited programs—such as incorporating control groups where possible, leveraging synthetic and real-world data, and adopting adaptive trial designs to reduce regulatory risk.

In this Q&A, Rohit Nambisan, CEO of Lokavant, and Jonathan Crowther, head of predictive analytics, Pfizer, explore how AI is transforming study feasibility, regulatory review, and trial execution.

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the previous week with a look into the FDA’s heightened scrutiny of trial design, the wind-down of federal mRNA vaccine programs, and how digital innovation is reshaping the clinical research landscape.

A unified technology approach improves study efficiency and data collection.

As clinical trials become more complex, success depends on early collaboration, thoughtful protocol design, and practical strategies to manage risk, reduce delays, and support patients.

In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, outlines how even unenforced executive orders can influence federal funding decisions, prompting sponsors and sites to alter public trial messaging to avoid informal scrutiny.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how recent executive orders are creating uncertainty around compliance for clinical research teams receiving federal funding, and why staying alert to agency interpretation is key.

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.

Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and highlights global momentum behind Blenrep combination approvals.

In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, discusses the operational investments required to activate pharmacies as clinical trial sites, including staff training, regulatory coordination, and patient-facing technology.

Outdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with modern, compliant marketing tools could turn the tide.

In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how clinical trial sites and sponsors are responding to funding constraints by turning to telemedicine, cost-containment strategies, and increased reliance on industry-sponsored research.

In this video interview, Kyle McAllister, co-founder, CEO, Trially, explains how staffing reductions caused by clinical trial budget cuts are threatening patient recruitment and retention and warns of the long-term ripple effects on trial timelines and healthcare innovation.