Applied Clinical Trials July/August 2022 Issue (PDF)

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 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.

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 Phase III Clarity AD open-label extension trial (NCT03887455) suggest weekly subcutaneous maintenance dosing with Leqembi may offer a more convenient and well-tolerated alternative for patients continuing long-term treatment.

In Study 2 of the Phase III UP-AA trial, upadacitinib 15 mg and 30 mg met primary and secondary endpoints for scalp hair regrowth in patients with severe alopecia areata.