Eisai announced that, in order to further promote transparency in clinical trial data disclosure, it has determined its policy on clinical trial data disclosure and is making clinical trial data publicly available to researchers via an external website.
Eisai announced that, in order to further promote transparency in clinical trial data disclosure, it has determined its policy on clinical trial data disclosure and is making clinical trial data publicly available to researchers via an external website (www.clinicalstudydatarequest.com).
Eisai’s "Policy on Clinical Trial Data Access and the Disclosure of Clinical Trial Information" is published on the Eisai corporate website. This policy outlines Eisai's direction, regarding clinical trial registration, disclosure and publication of clinical trial results, as well as access to clinical trial data for researchers.
After researchers have submitted a request through the website, it is then reviewed by an independent review panel which Eisai has no influence upon. If the request for data is approved, Eisai will then provide the researchers with rights to access the anonymized clinical trial data. Data will be shared for clinical trials for products submitted and approved after January 1, 2014, in Europe and the United States.
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.