Applied Clinical Trials, November 2018 Issue (PDF)

A new myTomorrows survey of physicians in the United States highlights the need for smarter, AI-driven tools to overcome inefficiencies in clinical trial access and improve patient care timelines.

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.

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.

Viatris reported that its MR-139 ophthalmic ointment failed to meet its primary endpoint in a Phase III blepharitis trial, while advancing its MR-141 and MR-142 candidates in presbyopia and night vision impairment with positive late-stage results.

The Phase III INDEPENDENCE trial (NCT04717414) failed to meet its primary endpoint of achieving transfusion independence in patients with myelofibrosis-associated anemia treated with Reblozyl (luspatercept-aamt).