Applied Clinical Trials
Tufts CSDD
A 2012 study conducted by the Tufts Center for the Study of Drug Development shows that academic centers and hospitals take significantly longer to initiate industry-funded clinical trials. Overall, it takes an AMC or hospital more than one year (12.9 months) on average from the pre-study visit to first patient in (FPI) the clinical trial. This compares with 7.9 months for community-based physician practices to complete the same cycle—nearly a 40% time reduction. The Tufts CSDD study evaluated start-up cycle times for 5,296 investigative sites participating in 105 Phase II and III clinical trials. The largest bottleneck is the time from when the contract is received by the center to the time that the contract is executed. AMCs and hospitals take nearly 73% longer than their for-profit counterparts—4.1 months on average versus 1.1 months. Cycle times from contract execution to site initiation, and from site initiation to FPI for non- and for-profit investigative sites are much closer, suggesting that AMCs and hospitals perform more competitively once they get through their less efficient administrative tasks.
Figure 1
—Tufts Center for the Study of Drug Development, https://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.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.