TransCelerate BioPharma Inc., a non-profit collaboration comprised of 20 of the largest biopharmaceutical companies, today announced that it is expanding access to COVID-19-related patient-level clinical data sharing via DataCelerate® to non-member companies. In addition, TransCelerate will expand the type of data shared to include data from both the investigational product and control arms of COVID-19 clinical trials.
This announcement comes quickly following a decision last month to utilize the DataCelerate® platform to share control arm data from ongoing and planned COVID-19 clinical studies.
“As we face this unprecedented global health challenge, it is critical that the industry works collaboratively to rapidly produce effective and safe therapies,” said Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) and recently appointed Head of Therapeutics for Operation Warp Speed. “TransCelerate’s announcement of expanding access to data to non-member companies does just that. Increasing access and including the investigational product arm will improve future trial designs and facilitate collaboration and connection across the research community.”
DataCelerate® is a global cloud-based data sharing platform that allows for deidentified, anonymized pre-clinical and clinical data types to be requested and voluntarily shared. The DataCelerate® system and accompanying legal agreements provide an internationally compliant system protecting privacy rights in clinical data. It is a validated and trusted way to share data and has been utilized to power research activities across TransCelerate members since 2017. Fully-secured, DataCelerate® is built on AIP+ from Accenture Applied Intelligence.
“Time is of the essence to bring together the promising research being done to address this crisis. After our previous announcement, we immediately got to work to provide access, at no cost, for organizations who are developing vaccines and therapeutics for COVID-19,” said Dalvir Gill, Ph.D., CEO of TransCelerate BioPharma Inc. “We mobilized quickly to overcome technical barriers and ensure patient privacy to rapidly provide a secure way for the biopharmaceutical industry to share patient-level clinical trial data related to the study of this disease. The world is waiting for promising therapies and vaccines to provide relief to the global health and economic crisis. We don’t have the luxury for critical data to be siloed in different organizations.”
In other therapeutic areas, data shared via DataCelerate® has already been used to reduce the number of patients in clinical trials, improve trial design, assess safety signals, increase knowledge of disease and treatments and improve the understanding of global patient populations.
“We are grateful to be able to share our data related to COVID-19 with other companies working to develop treatments for this public health emergency,” said Michelle Rohrer, Ph.D., Senior Vice President, Global Head of Pharma Development Regulatory and Policy, Roche and Chair of TransCelerate’s Board of Directors. “By sharing our data and having access to data shared by other companies in a proven and secure platform, we all gain a better understanding of the disease and its potential treatments.”
As part of this expansion at least two non-member biopharma companies have expressed interest in sharing their COVID-19 clinical trial data within DataCelerate®, allowing the research community to leverage this highly-detailed data as they pursue COVID-19 vaccines and treatments.
COVID-19-related clinical data will accumulate in the DataCelerate platform and will be available for complimentary access to qualifying biopharmaceutical companies and biomedical research agencies.
To inquire about applying for access to DataCelerate®’s COVID-19 data sharing module, please visit: https://transceleratebiopharmainc.com/covid-19/.
About TransCelerate BioPharma, Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by simplifying and accelerating the research and development (R&D) of innovative new therapies. The organization’s mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions intended to drive the efficient, effective and high-quality delivery of new medicines. The vast majority of TransCelerate solutions are publicly available. Headquartered in Philadelphia, TransCelerate has 20 member companies and 30+ initiatives focused on improving the patient and site experience, enhancing sponsor efficiencies and drug safety and harmonizing process and sharing information.
Membership in TransCelerate is open to pharmaceutical and biotechnology companies with R&D operations. For more information, please visit http://www.transceleratebiopharmainc.com, https://twitter.com/TransCelerate, or https://www.linkedin.com/company/transcelerate-biopharma-inc-/.