TransCelerate Launches Two New Global Initiatives
TransCelerate BioPharma has established two new global initiatives in the clinical trials area. Both initiatives - Placebo / Standard of Care Data Sharing and Electronic Labels for Clinical Trials (e-Labels), are made possible through the collaboration of participating Member Companies.
The Placebo / Standard of Care Data Sharing Initiative is to create a framework for data sharing that allows for the leverage of data from previous studies respecting boundaries of informed consent. It 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. The platform will be provided to Member Company biostatisticians to hopefully lead to improved protocol development, reduction in protocol amendments and a better understanding of disease models to identify the right targets. The goal is to maximize the value from the data generated from a patient participating in a clinical trial, as well as the R&D investment.
The e-Labels Initiative will support TransCelerate Member Companies in establishing an innovative information channel: Electronic Labels (e-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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
