Applied Clinical Trials
TTC
Only one in 10 self-originated drugs targeting diseases of the central nervous system (CNS) that entered clinical testing between 2002 and 2007 were approved. As such, CNS drugs have a success rate that is half that of the overall clinical approval success rate. Drug developers face numerous challenges in developing treatments targeting complex chronic illnesses in CNS including very demanding protocol designs and substantially longer development and regulatory review times. The clinical phase through approval duration for CNS drugs, for example, was 32 months longer than that of non-CNS drugs. Mean clinical phase duration for CNS drugs was 40% longer and the regulatory review and approval duration was 13% longer. CNS drugs are also far less likely to receive priority review status: between 1996 and 2010, non-CNS drugs were two-and-a-half times more likely to receive a priority review rating from the US Food and Drug Administration. The CNS new product pipeline, however, is among the richest, accounting for 11% of all drug development projects worldwide and growing by 6% annually.
Phase transition probabilities for self-originated CNS drugs and the benchmark for all TAs (2002-2007).
—Tufts Center for the Study of Drug Development, http://csdd.tufts.edu.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In 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.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.