Clinical Trials Results Reporting Improved with Email Reminders
BMJ last month posted a research article that shows researchers are more likely to post the results of their trials if they are sent an email reminder.
BMJ last month posted a research article that shows researchers are more likely to post the results of their trials if they are sent an email reminder. Since 2007, the FDA has required registration of clinical trials conducted in the United States on ClinicalTrials.gov before they begin and to post summary results within one year of completion of the trial. However, about 75% of trials on ClinicalTrials.gov haven’t reported results. The BMJ study focused on Phase IV trials that were closed for recruitment with at least one site in the United States. The experimental intervention "consisted of sending reminders of the FDAAA 801 requirement through personalized emails to responsible parties of the randomly selected trials. The emails were constructed as surveys, notifying responsible parties of trials that the primary completion date was over a year old and asking for the reasons why they had not posted results on the register (see supplementary appendix). In fact the survey was a “cover” for the reminder." At three months, 19% trials in the intervention group had posted results versus 13% in the control group. At six months, 24% trials in the intervention group had posted results versus 14% in the control group.
Read the full report 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.
