Novartis has renewed its commitment to clinical trial data transparency
Novartis has renewed its commitment to clinical trial data transparency by revealing that from the end of 2014, it will produce enhanced clinical study reports for all new pivotal studies that will reportedly include easy-to-understand consumer-language summaries and additional interpretation of data.
According to a statement issued on February 26, “Novartis has long supported data transparency and was the first company to publish positive and negative study results of its innovative medicines within one year of the study completion further enabling clinical research while protecting patient privacy.”
To date, Novartis says it has registered 2,720 trials on ClinicalTrials.gov and published 559 trial results on the same site, as well as 1,777 clinical study summaries (so-called redacted clinical study reports). Researchers can also now request access to patient level data on newly approved innovative medicines in 2014 through the same Idea Point portal as other pharmaceutical
companies, it states.
Novartis has taken action to extend its leadership in data transparency and access to data by researchers, and this is designed to advance science and innovation that can benefit patients, noted Tim Wright, Global Head of Development at Novartis Pharmaceuticals.
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.