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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.