Using Adaptive Interim Analysis to Calculate Sample Size in a Trial of a Treatment for Erectile Dysfunction

The JADE study will be evaluating BI 1584862, an investigational oral compound that targets inflammation and preserves vascular function.

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.

Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.

JNJ-1900 (NBTXR3), a novel, potentially first-in-class oncology therapy, demonstrated a median overall survival of 23 months from date of diagnosis as well as a favorable safety profile.

A Phase III randomized trial published in JAMA Network Open found no significant difference in symptom improvement between onabotulinumtoxinA injections and midurethral sling surgery in women with moderate to severe mixed urinary incontinence, with many ultimately needing both therapies to sustain relief.