News

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed articles of the week—featuring updated cost estimates for trial delays, the benefits of a hybrid approach to site payments, and strategies for keeping complex protocols on track.

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 the Phase II STARLIGHT trial, MCO-010 gene therapy improved visual acuity in Stargardt disease patients, with some achieving early and sustained gains and no serious adverse events, paving the way for a Phase III study.

The trial’s first patient has been treated to assess the BREATHE Airway Scaffold, which was developed to enhance breathing and daily functioning in patients with severe emphysema.

A 2025 survey highlights growing momentum for multi-indication drug development, with opportunities in innovative trial design, targeted patient selection, and real-world evidence to speed label expansion.

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.

Ron Lanton, partner, Lanton Law, explains why evolving federal guidance and new technologies are pushing clinical operations teams to strengthen oversight and safeguard the credibility of clinical research.

In this randomized, double-blind trial, Aligos Therapeutics is evaluating its investigational oral capsid assembly modulator ALG-000184 against tenofovir disoproxil fumarate in 200 treatment-naïve patients with chronic HBV infection, with interim results expected in 2026 and topline data in 2027.

Results from the Phase II COLLECTiVE202 trial (NCT05370885) demonstrated a statistically significant difference between VE202 and placebo in producing endoscopic or clinical responses in patients with mild-to-moderate ulcerative colitis.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses whether recent trial design rejections signal a broader shift in FDA expectations or simply reflect changes in individual reviewers, emphasizing that current unpredictability may be more situational than systemic.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI and digital twins are helping clinical trials become more efficient, patient-centric, and capable of supporting innovative study designs over the next decade.

In this episode of the Applied Clinical Trials Brief, we spotlight a recent video interview with Luke Wilson of Thermo Fisher Scientific in which he shared insights on how data visibility, remote monitoring, and integrated systems can streamline inspections, improve patient safety, and keep decentralized trials compliant and on track.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI and digital twin technologies are being applied to improve data transparency, ensure reproducibility, and strengthen the reliability of clinical trial outcomes.

Results from a Phase II trial (NCT06640972) showed that patients treated with RDX-002 experienced significant reductions in postprandial triglycerides, less weight regain after GLP-1 therapy, and improvements in key cardiometabolic markers.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, explains why sponsors pursuing breakthrough or priority review designations must maintain rigorous trial design while building organizational agility.

Bringing some payment activities in-house while outsourcing others can help sponsors optimize clinical trial efficiency, reduce risks, and strengthen site relationships.

In the Phase III VAYHIT2 trial, ianalumab combined with eltrombopag significantly prolonged time to treatment failure and improved sustained platelet counts in patients with primary immune thrombocytopenia previously treated with corticosteroids, with a safety profile consistent with prior findings.

In this Phase III trial, the Padcev-Keytruda combination used as both neoadjuvant and adjuvant therapy significantly improved event-free and overall survival, as well as pathologic complete response, compared to surgery alone in cisplatin-ineligible patients with muscle-invasive bladder cancer.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses recent Complete Response Letters issued to Replimune and Capricor, explaining how shifts in FDA reviewers can affect single-arm trial acceptance, especially in oncology settings where control groups may be deemed unethical.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how regulators are clarifying best practices for integrating AI and digital twins into clinical research.

The global Phase III EMPEROR trial (NCT06872125) will evaluate the safety and efficacy of zorevunersen, a novel antisense oligonucleotide designed to reduce seizures and improve cognitive and behavioral outcomes in children with Dravet syndrome.

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.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, examines how recent developments with Complete Response Letters have shifted industry perceptions of FDA breakthrough designation—highlighting that it offers faster review timelines and investor visibility, but not a higher likelihood of final approval.

In the Phase III ENVISION trial, Zusduri achieved a 24-month duration of response rate of 72.2% among patients with a complete response at three months, reinforcing its potential as a durable treatment option for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.

Results from the Phase III EPCORE FL-1 trial (NCT05409066) showed that patients treated with Epkinly (epcoritamab) in combination with Rituxan (rituximab) and Revlimid (lenalidomide) for relapsed or refractory follicular lymphoma demonstrated significant improvements in overall response rate and progression-free survival.

A unified technology approach improves study efficiency and data collection.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, shares key strategies for maintaining operational alignment and compliance in decentralized trials including unified data platforms, aligned SOPs, and clear governance and escalation pathways between sponsors and supply chain partners.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how digital twins provide patient-level predictions that enhance trial precision, reduce enrollment needs, and support AI-driven drug development.