Clinical Trial News

Researchers used UK real-world clinical data to emulate a trial comparing apixaban and warfarin for stroke prevention in atrial fibrillation patients, finding similar outcomes but no superiority of apixaban, suggesting the method's effectiveness for underrepresented patient groups.

The FDA issued updated draft guidance on clinical trial diversity, emphasizing Diversity Action Plans (DAPs) to improve participation of underrepresented populations in clinical trials. DAPs require enrollment goals disaggregated by race, ethnicity, sex, and age group, and strategies to achieve these goals include community engagement and cultural competency training. The guidance also outlines submission requirements for drugs and devices. The NHC supported this legislation and will provide input by September 26. Additionally, the Clinical Trial Modernization Act (CTMA) was introduced to address economic barriers to clinical trial participation, supported by the NHC.

A phase 2 clinical trial, FELL-HD, tests felodipine's tolerability in Huntington disease (HD) patients, aiming to recruit 18 genetically confirmed HD patients aged 35-70 with early clinical features. Participants are given varying doses of felodipine over 58 weeks, followed by a 4-week follow-up, with the primary outcome being the number of adverse events. Additional measures include quality-of-life scales, cognitive and motor function, nonmotor symptoms, and disease biomarkers assessed through MRI. Blood and cerebrospinal fluid samples will also be analyzed. Felodipine, an approved hypertension drug, has shown strong autophagy-inducing effects in preclinical HD models.

Merck's Keytruda failed in two clinical trials for early-stage lung and skin cancer, leading to early termination. This setback impacts Merck's expansion plans for Keytruda before its patent expires in 2028, despite the drug being one of the best-selling pharmaceuticals with $14 billion in sales in the first half of 2024.

Merck discontinues two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630, evaluating KEYTRUDA in different cancer treatments due to lack of efficacy and safety concerns. KEYNOTE-867, testing KEYTRUDA with SBRT for NSCLC, showed no improvement in EFS or OS and higher AEs. KEYNOTE-630, assessing KEYTRUDA for adjuvant treatment of high-risk cSCC, was stopped for futility as it did not meet RFS significance. Safety profiles were consistent with established data. Merck advises patients to consult their physicians for next steps.

Ireland's Health Service Executive is developing a new four-way model template for clinical trial agreements (CTAs) to improve the country's clinical trials performance, in collaboration with the Irish Pharmaceutical Healthcare Association (IPHA). This follows a report showing Ireland attracting fewer trials than comparable European countries, aiming to standardize CTAs to reduce costs and delays in trial initiation.

Mary Ellen Vajravelu, MD, MSHP, received an NIH R01 grant for a clinical trial combining CGM, activity trackers, and a custom smartphone health app to treat youth-onset type 2 diabetes.

Leo, diagnosed with a low-grade glioma in 2023, participates in a trial testing a new drug for pediatric low-grade gliomas, aiming to stabilize tumors and reduce long-term treatment side effects.

Jazz Pharmaceuticals' Epidyolex failed Phase 3 trial in Japan; British American Tobacco invests in cannabis for growth; DanCann Pharma reports strong Q2 with record revenue and positive EBITDA.

A study by Juntendo University researchers assessed whether suvorexant, a sleep-promoting medication, could reduce delirium in older adults. Published in JAMA Network Open, the double-blind, placebo-controlled trial found suvorexant showed a trend towards reducing delirium, particularly hyperactive and mixed types, though the difference was not statistically significant.