TransCelerate BioPharma Inc. has established two new global initiatives aimed at accelerating and enhancing clinical trials in collaboration with participating Member Companies. The initiatives include Placebo/Standard of Care Data Sharing and Electronic Labels for Clinical Trials (e-Labels).
 
The Placebo / Standard of Care Data Sharing Initiative aims to create a framework with the potential to reduce the number of patients needed for a clinical trial, allowing the use of data from previous studies under informed consent. It also offers the potential for more rapid understanding of safety signals, as well as help to identify statistical techniques that may deliver more accurate study design and statistical power calculations.
 
Ulo Palm, M.D., Ph.D., senior vice president, head of Global Brands Drug Development Operations at Actavis, and TransCelerate executive sponsor for the initiative said, “The TransCelerate solution has the potential to change the way clinical trials are designed, planned and executed. Providing this platform to Member Company biostatisticians may lead to improved protocol development, reduction in protocol amendments and a better understanding of disease models to identify the right targets, including rare disease models.”
 
The e-Labels Initiative aims to establish an information channel: Electronic Labels (e-Labels) to enhance label utility for patients, provide more consistent labeling approaches for sites and offers the potential to reduce clinical labeling timelines. The Initiative, in collaboration with Regulatory Agencies, will develop guidance to facilitate implementation of e-Labeling.
  
Craig Lipset, head of Clinical Innovation at Pfizer, and Executive Sponsor of the TransCelerate e-Labels Initiative, said, “This effort aims to make product information more accessible to patients and to permit deeper engagement during the clinical trial process.”