TransCelerate BioPharma, a nonprofit organization dedicated to improving the health of people around the world by accelerating and enhancing the R&D of innovative new therapies, has established two new global initiatives which will accelerate and enhance clinical trials. Both initiatives, Placebo/Standard of Care Data Sharing and Electronic Labels for Clinical Trials (e-Labels), aim to create solutions that will have a direct impact on patients, sponsors and investigative sites.
The Placebo/Standard of Care Data Sharing Initiative has the potential to create a framework for data sharing that offers the potential to reduce the patient population needed to be enrolled in a clinical trial, as it intends to allow for the leverage of data from previous studies respecting boundaries of informed consent. It would thereby decrease the time spent on cumulative trial execution, and assists in acceleration of new therapies to patients. It also offers the potential for more rapid understanding of safety signals to better manage patient safety during clinical trials, as well as 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."
Ed Bowen, senior director, translational and bioinformatics at Pfizer and the lead of this initiative, said, “Sharing placebo and standard-of-care data is good for patients and good for our R&D organizations. Data re-use is especially important in rare diseases where patient populations are small. We want to maximize the value from the data generated from a patient participating in a clinical trial, as well as the R&D investment. We strongly desire to speed the delivery of innovative therapies to underserved patients. Pooling this data among TransCelerate member companies has the potential to be powerful and is representative of TransCelerate's overall mission, which is to provide efficient, effective and high quality outcomes for the larger clinical ecosystem through member company collaboration."
The e-Labels Initiative will support TransCelerate member companies in establishing an innovative information channel: electronic labels. This initiative will work to enhance label utility for patients, provide more consistent labeling approaches for sites and offers the potential to reduce clinical labeling timelines and provides cost efficiencies for sponsors. The Initiative, in collaboration with regulatory agencies, will develop guidance to facilitate implementation of e-labeling.