A big announcement in the pharmaceutical world has been the new establishment of two global initiatives that will improve and accelerate clinical trials. TransCelerate BioPharma Inc. unveiled that through a collaboration of participating member companies, these initiatives could be made possible.
The Placebo/Standard of Care Data Sharing Initiative and Electronic Labels for Clinical Trials (e-Labels) Initiative were announced recently and both aim to create solutions that will directly impact sponsors, patients and investigative sites. The e-Labels Initiative will support the Member Companies of TransCelerate and will seek to establish an innovative information channel: Electronic Labels. It will work to provide more consistent labeling approaches for sites that will enhance label utility for patients. The e-Labels Initiative will offer the potential to reduce clinical labeling timelines which will provide a more cost efficient solution for sponsors. The Initiative, will be working alongside Regulatory Agencies in order to develop guidance that will facilitate implementation of e-Labeling.
Craig Lipset, head of Clinical Innovation at Pfizer, and the 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.” Terry Walsh, Head of Comparator Strategy and planning at GlaxoSmithKline and the lead of the initiative believes that “The time is right for pharma companies to embrace e-labeling as a critical component to their clinical supply chain strategy,” and that “The TransCelerate e-label Initiative is aligned with our primary goals of collaborating with critical stakeholders, challenging inefficiencies and driving value into the clinical trial landscape.”
The other initiative that was announced, the Placebo/Standard of Care data Sharing Initiative, has the ability to create a framework for data sharing that offers the potential to decrease the number of patients that need to be involved in a clinical trial. It will allow for the leverage of data from previous studies, respecting the confines of informed consent. This initiative means a decrease in the amount of time that is spent on cumulative trial executive which in turn assists in acceleration of new therapies to patients. The initiative also allows the potential for more rapid understanding of safety signals in order to better manage patient safety during the clinical trial phase. Statistical techniques will be more identifiable thus to deliver more accurate study design and statistical power calculations.
Ulo Palm, MD, PhD, SV, head of Global Brands Drug Development Operations at Actavis, and TransCelerate Executive Sponsor for the initiative said of the initiative said, “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 announcement is an example of partnerships being formed in order to advance the development of clinical trials and improve patient care globally. TransCelerate will be speaking at the Partnerships & Clinical Trials Conference this week. To see who else is speaking this week please visit the website: http://bit.ly/1E6raKF