What Resilient Trial Design Means for Clinical Teams
September 2nd 2025In this video interview, Sunny Kumar, MD, partner at Informed Ventures, discusses how FDA guidance and investor expectations are shaping resilient trial designs that use adaptive methods, virtual controls, and decentralization to lower costs and accelerate patient access.
Why Clinical Trial Innovations Take Years to Gain Adoption
August 29th 2025In this video interview, Sunny Kumar, MD, partner at Informed Ventures, explains how organizational complexity, regulatory caution, and cultural risk aversion slow innovation in clinical trials, while tools like generative AI may help reduce operational barriers.
Addressing the Digital Divide in Decentralized Trials
August 28th 2025In this video interview, Sunny Kumar, MD, partner at Informed Ventures, discusses how clinical operations leaders can close technology gaps in decentralized trials by provisioning devices and designing simple, intuitive tools to ensure equitable patient access.
FDA Authorizes New COVID Vaccines with Restrictions on Eligibility
August 27th 2025FDA approves COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax targeting the LP.8.1 sublineage of SARS-CoV-2, with eligibility limited to adults aged 65 years and older and those with underlying medical conditions that place them with a high risk for severe disease.
Phase III NIMBLE Trial Demonstrates Cemdisiran Efficacy in Generalized Myasthenia Gravis
August 27th 2025The Phase III NIMBLE trial met its primary and key secondary endpoints, with cemdisiran monotherapy showing robust efficacy in generalized myasthenia gravis and the cemdi-poze combination achieving near-complete complement inhibition. Regeneron plans a 2026 US regulatory submission.
Beyond Prediction: An Evidence-Based Framework for Assessing Site Selection Decisions
August 27th 2025A new systems-based framework helps sponsors and CROs move beyond prediction to understand why site selection succeeds or fails, enabling targeted interventions that boost recruitment, data quality, and trial efficiency.
How Research Sites Balance Funding Cuts and Efficiency Pressures
August 26th 2025Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), and Kyle McAllister, co-founder, CEO, Trially, discuss how research sites are navigating political funding pressures, adapting to NIH budget constraints, and leveraging new cost-containment strategies to sustain clinical research.
ACT Brief Episode 6: Supreme Court Ruling, VK2735 Obesity Trial, and Padcev-Keytruda Survival Gains
August 25th 2025In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the week—covering the Supreme Court’s decision to uphold NIH funding cuts tied to DEI, Phase II data showing oral VK2735 achieved over 12% weight loss, and Phase III results where Padcev plus Keytruda improved survival in muscle-invasive bladder cancer.
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.