TransCelerate’s Member Company experts were featured in the press on a variety of topics throughout the last few months on a number of topics from data sharing to the ongoing pandemic. Read on to catch up on our latest news.
CDISC Issues New Industry Standard with TransCelerate Support
In 2019, TransCelerate’s Common Serious Adverse Events Fields Initiative gathered input from its clinical and pharmacovigilance members to identify the common core fields collected and reported following a Serious Adverse Event (SAE). Once complete, TransCelerate transitioned its “Common SAE Fields Project Overview & Outputs” slide deck and methodology to the Clinical Data Interchange Standards Consortium (CDISC). CDISC has worked for the past year to develop and release its newest guidance, the CDASH SAE V2.0 Supplement. CenterWatch’s Charlie Passut interviewed CDISC and TransCelerate on the new 50-page report and the 156 key factors that TransCelerate identified to help reduce the among of duplicate SAE data that do not meet sponsor and regulatory requirements. This process can be very time consuming for sites as the FDA reports that it receives over 1 million adverse event reports each year.
The Importance of Data Sharing to Improve Clinical Trials
Member Company UCB highlighted its participation in our Historical Trial Data Initiative in a piece celebrating 2021’s Clinical Trials Day, highlighting how the Initiative works to maximize the value of clinical data collected in the control arms of clinical trials. This historical data from the control arms of clinical trials holds much value for researchers in the discovery, analysis, and the design and execution of future trials. On the same topic, three of TransCelerate’s HTD members authored an article in Life Science Leader on a three-step approach to unlock the power of Historical Trial Data during clinical trials.
TransCelerate’s newest initiative, Diversity of Participants in Clinical Trials, was quoted in an article on the importance of improving the underrepresentation of different ethnic and racial groups within clinical trials by providing tools and information to organizations working to improve the representation of diverse populations in clinical trials. As part of this new initiative, TransCelerate will undertake race and ethnicity enrollment data benchmarking. This will identify priority disease states with disparity between disease prevalence and study representation among racial or ethnic groups to establish a current state benchmark for tracking future progress.
BioCelerate Enters Public Private Partnership with the FDA
BioCelerate, our nonclinical subsidiary, recently announced its first set of solutions as part of its Public Private Partnership (PPP) with the U.S. FDA’s Center for Drug Evaluation and Research (CDER) Office of Computational Science. This PPP was established to better enable analytic approaches and identify solutions to optimize cross-study analysis. As part of this PPP, BioCelerate and the FDA have released two peer-reviewed publications authored by BioCelerate’s SEND Harmonization & Cross-Study Analysis Initiative. The first paper discusses the potential of SEND datasets for cross-study analysis and outlines current challenges. The second paper proposes next steps to leverage learnings and how to continue to share findings. This PPP will assist life science companies and organizations optimize the implementation of the Clinical Data Interchange Standards Consortium’s (CDISC) Standard for Exchange of Nonclinical Data (SEND), to ensure nonclinical data can be presented in a harmonized format across the ecosystem.
Want to read up on all recent news articles? Check out our News & Events page for a full archive of our media interviews.
Leigh Anne is the Communications Manager at TransCelerate Biopharma, Inc. In this role, she is responsible for all corporate communications, public relations, and marketing efforts on behalf of the company. This includes creating and executing public relations campaigns; maintaining and drafting content for blogs, newsletters, press releases and other internal and external communications; media relations; and planning conference strategies. Leigh Anne has over 15 years of experience and holds a BA in Public Relations from Susquehanna University.