FDA Awards ICON with Project Validating PROs

In the BOHEMIA study, once-monthly ivermectin over 3 months significantly reduced malaria incidence versus albendazole in children aged 5 to 15 years, supporting its role as a novel vector-control tool amid rising insecticide resistance.

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.

In a pre-specified sub-study of the BROADWAY trial, obicetrapib 10 mg significantly reduced plasma p-tau217 levels in patients with ASCVD, including ApoE4 carriers, suggesting dual potential to lower LDL-C and impact Alzheimer’s disease progression.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Results from the long-term extension of the Phase III TRAILBLAZER-ALZ 2 trial (NCT04437511) showed sustained benefits with early Kisunla treatment, including reduced risk of disease progression and high rates of amyloid clearance in early Alzheimer disease.

In the ongoing Phase II CRDF-004 trial, onvansertib plus standard-of-care showed a 49% confirmed ORR and early PFS benefit in first-line RAS-mutated metastatic colorectal cancer, with a favorable safety profile and dose-dependent efficacy across endpoints.