The placebo/standard of care initiative seeks to create a framework to allow for data sharing to reduce the patient population needed to be enrolled in a clinical trial. The sharing of data would also help to decrease the time spent on cumulative trial execution. It also offers the potential for more rapid understanding of safety signals to better manage patient safety, as well as to identify statistical techniques that may deliver more accurate study design and statistical power calculations.
Ulo Palm, SVP, Head of Global Brands Drug Development Operations at Actavis, and TransCelerate Executive Sponsor for 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."
Ed Bowen, Senior Director, Translational and Bioinformatics at Pfizer and the lead of this initiative, added, “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."
TransCelerate member companies include nearly all of the top biopharma companies, including Pfizer, Roche, Sanofi, GlaxoSmithKline and Eli Lilly. A TransCelerate spokeswoman told Outsourcing-Pharma.com: "We have just completed a Request For Proposal (RFP) process and selected a partner for mapping and hosting the data. We expect to have data available for sharing in Q3 of 2015."
The other recently announced initiative – the e-Labels Initiative -- will support TransCelerate members in establishing an information channel that increases the consistency of 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.
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.”
“The time is right for pharma companies to embrace e-labeling as a critical component to their clinical supply chain strategy,” added Terry Walsh, Head of Comparator Strategy and Planning at GlaxoSmithKline and the lead of this initiative.
Both initiatives come as TransCelerate also looks to tackle investigator selection bias and risk-based monitoring. And although CROs will not become members of TransCelerate, the Association of Clinical Research Organizations recently opened up ways for CROs to interact with the members-only group. The group is also working with CROs to establish training programs for clinical research staff.