Global clinical trial performance and efficiency are hampered by high turnover and noncompliance among principal investigators and wide variation in investigative site experience.
Global clinical trial performance and efficiency are hampered by high turnover and noncompliance among principal investigators and wide variation in investigative site experience, according to a recently completed assessment by the Tufts Center for the Study of Drug Development.
While the number of investigators globally now stands at nearly 40,000, a record, half of them were new to the job in 2013, the most recent year for which data are available, according to Tufts CSDD. In addition, although the highest turnover rates are observed among the least active investigators, turnover rates have been getting progressively worse among more active investigators. The report found the growth in the number of unique principal investigators is beginning to decelerate: the most recent four-year annual growth rate was 3.3% compared with the prior four-year period of 4.1% and an average of 5.6% over the last 15 years.
Read the full release here.
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.