Applied Clinical Trials Digital Edition - June/July 2015

Results from the Phase III EMBARK trial show that in combination with leuprolide, Xtandi (enzalutamide) demonstrated a statistically significant and clinically meaningful overall survival benefit in men with non-metastatic hormone-sensitive prostate cancer and high-risk biochemical recurrence.

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.

In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.

Outdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with modern, compliant marketing tools could turn the tide.

The Phase I/IIa CLARICO trial of OpCT-001 marks the first clinical trial of an investigational induced pluripotent stem cell-derived therapy for primary photoreceptor diseases.