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TransCelerate BioPharma in the News Q1 2022

TransCelerate’s Member Company experts and initiatives were featured in the press on a variety of topics throughout the last few months on several topics from data sharing to clinical trials. Read on to catch up on our latest news.

The Patient Pipeline in Clinical Trials

It was a busy first quarter with TransCelerate’s Clinical Content & Reuse Initiative being featured in a BMJ Open article, “Estimands: bringing clarity and focus to research questions in clinical trials.” Our common protocol template, which includes proposed model estimands, was used as an example of how researchers and sites could adhere to the ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials while researching treatments for Parkinson’s Disease. TransCelerate’s estimand template was used to precisely understand the treatment effect being estimated within the featured case study.

Our Patient Technology Initiative has developed a variety of resources available to accelerate the adoption of patient-facing digital technologies in clinical trials, most recently as it relates to Novel Digital Endpoints (NDEs). Member Company contributor Michelle Crouthamel, head of digital science at AbbVie, authored the article “When & How to Develop a Novel Digital Endpoint in Clinical Research” for Clinical Leader. Biopharmaceutical companies leverage digital health technologies such as mobile health apps, wearable sensors, telehealth, and more to improve existing endpoints or to uncover new endpoints. Our recently published paper in Digital Biomarkers, “Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations,” walks through the process and key considerations for developing and navigating regulatory acceptance of digital tools for NDE implementation in a clinical trial, using a case study example.

Our Patient Experience Initiative is a true testament to putting patients in the driver’s seat as our teams have tailored solutions that allow patients to have more input into their overall clinical trial experience. This initiative, as well as our other patient-centric initiatives like the Diversity of Participants in Clinical Trials Initiative, was named in an Outsourcing Pharma article on addressing the challenge of underrepresentation in trials. To help patients, sites, and biopharma as a whole, it’s important to focus on patient perspectives and understandable terminology. For example, our proposed eLabels wireframe was mentioned in the Healthcare Packaging article “Manage Challenges from the EU 536/2014 Clinical Trials Regulation.”

Scott Askin, global program regulatory director for innovation at Novartis, noted TransCelerate’s work within our Modernizing Clinical Trials Initiative that helps to develop practical guidance and tools for the success of clinical trial continuity solutions. The Clinical Research News article, “Rules and Roles of Decentralized Clinical Trials Coming into View,” summarized some best practices for decentralized clinical trials that were shared at this year’s Summit for Clinical Research Ops Executives (SCOPE) conference.

How TransCelerate is Facilitating Data Flow and Data Sharing

Data sharing is critical throughout the clinical trials and drug safety stages to help accelerate the rate of new medicinal and therapeutic discoveries. An article in the Journal of Participatory Medicine named TransCelerate as an organization working to develop and maintain tools that help enable clinical trial data sharing while adhering to existing data standards. Even our preclinical subsidiary BioCelerate was mentioned in a F1000 Research article on building a sustainable drug safety data sharing framework through our Toxicology & Background Control Data Sharing Initiative.

To effectively share data, the healthcare and biopharma ecosystems are increasingly turning to collaboratively built open-source solutions to enable interoperability and connectivity across systems. Our Digital Data Flow Initiative aims to facilitate the exchange of structured study definitions across clinical systems. Our efforts in building a Study Definitions Reference Repository Implementation alongside Microsoft, Accenture, and CDISC was referenced in the Clinical Leader article “4 Lessons for Open-Source Collaborations in Clinical Research.”

Finally, TransCelerate’s Chief Operating Officer Janice Chang penned the article “Why Drug Safety is Ripe for an AI Revolution” for Pharma Tech Outlook to share insights on how artificial intelligence (AI) can be used to drive efficiencies in drug safety. Our Intelligent Automation Opportunities in Pharmacovigilance (IAO) Initiative created the Interactive ICSR and Automation Technologies Tool to help organizations identify opportunities for intelligent automation within their pharmacovigilance practices.

Want to read up on all recent news articles? Check out our News & Events page for a full archive of our media coverage.

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