Supreme Court Upholds NIH Funding Cuts Affecting DEI in Clinical Research
August 22nd 2025The 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.
Building Partnerships to Better Serve Underrepresented Trial Communities
August 22nd 2025In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), explains why trial inclusivity requires shared responsibility across sponsors, CROs, sites, and advocacy groups.
NCX 470 Meets Phase III Goal in Glaucoma With Strong Intraocular Pressure Reductions
August 21st 2025The Denali trial confirmed non-inferiority of NCX 470 to latanoprost in lowering intraocular pressure, with consistent efficacy, favorable safety, and supportive results from the earlier Mont Blanc study.
How Flexible Site Models Can Cut Recruitment Costs and Timelines
August 21st 2025In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), highlights how listening to site insights and adopting flexible models such as temporary community-based clinics, can reduce patient travel burdens, improve enrollment efficiency, and stretch trial budgets further.
ACT Brief Episode 5: How Digital Twins and AI Are Reshaping Clinical Trials
August 20th 2025In 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.
Overcoming Budget Barriers to Patient-Centric Trial Models
Published: August 20th 2025 | Updated: August 20th 2025In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), outlines how rigid budgeting and limited sponsor-site dialog often block innovative patient-centric solutions, stressing the need for more collaborative approaches to enable community engagement and flexible trial delivery.
How In-Home and Community Strategies Boost Recruitment and Diversity
August 19th 2025In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), explains why site-enabled approaches such as in-home visits and community-based outreach should be offered from the start of a trial to reduce recruitment delays, support patient needs, and improve trial diversity.
Phase II Trial Launches to Evaluate Hepzato in Liver-Dominant Colorectal Cancer
August 19th 2025The first patient has been dosed in a global Phase II study assessing Hepzato in combination with trifluridine-tipiracil and bevacizumab for liver-dominant metastatic colorectal cancer, with primary results expected by mid-2028.
Oral GLP-1/GIP Dual Agonist VK2735 Achieves Up to 12% Weight Loss in Phase II VENTURE Trial
August 19th 2025The Phase II VENTURE-Oral Dosing study of VK2735 met primary and secondary endpoints, with once-daily treatment leading to progressive weight reductions, high responder rates, and encouraging safety over 13 weeks.
The Reality of Operational Flexibility for Trial Sites
August 18th 2025In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), discusses the challenges of achieving true operational flexibility in clinical trials—highlighting how SOPs, staffing, and budget constraints often limit site adaptability and contribute to staff burnout.
FDA Grants Breakthrough Therapy Designation to Izalontamab Brengitecan for EGFR-Mutated NSCLC
August 18th 2025The FDA has awarded Breakthrough Therapy Designation to izalontamab brengitecan, a potential first-in-class bispecific antibody-drug conjugate, for patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who progressed after EGFR TKI and platinum chemotherapy, based on data from multiple clinical trials.
ACT Brief Episode 4: New Data on Trial Delays, Hybrid Payment Models, and Managing Complexity
August 18th 2025In 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.
Phase II Trial Demonstrates Vision Gains in Stargardt Disease With MCO-010
August 15th 2025In 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.
Future-Proofing Trial Protocols to Avoid CRLs
August 15th 2025In 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.
The Critical Role of Clinical Ops Teams in Maintaining Clinical Trial Integrity
August 15th 2025Ron 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.
Phase II B-SUPREME Trial Launches for ALG-000184 in Chronic Hepatitis B
August 14th 2025In 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.
Is FDA Trial Design Scrutiny Increasing or Just Less Predictable?
August 14th 2025In 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.