This is the first article in a five-part blog series about TransCelerate’s data sharing initiatives. This first piece will explore the foundations of our data sharing work. Future topics in this series will include our work on data sharing to support a robust response to COVID-19, patient privacy, and toxicology, among others.
TransCelerate BioPharma was founded in 2012 with the goal of collaborating across the ecosystem to tackle pain points and inefficiencies in research and development. For example, the Comparator Network was launched to enable sponsors to reliably and rapidly source quality comparator products from each other for use in clinical trials, improving continuity of supply and enhancing confidence in the source of materials. This spirit of cross-sponsor sharing has since extended to multiple opportunities within TransCelerate, including the sharing of R&D data.
Organizations are investing heavily in digital transformation, new data sources and advanced analytics that can power and optimize research and development. One such novel approach is to re-use the historical data collected by research sponsors from both clinical (human) and nonclinical (animal) studies. Rather than using these data only once for the originally intended research study, great potential exists to reuse these data for downstream research purposes across multiple organizations seeking to advance new and better treatments for disease.
The Opportunity of Historical Data Sharing
Compared to other industries, the biopharmaceutical community has been slower to adopt large-scale utilization of historical data to innovate products and improve operational processes. Data collected from historical research has the potential to improve future study design, minimize the number of new patients required to power research, and deliver new insights to advance the development process.
While plentiful, historical data is underutilized. Research sponsors commonly invest significant resources to collect valuable, high-quality, subject-level data that is only used once or only used by the original sponsor. This limits the potential value of the data and may result in unnecessary duplication in the research system, causing inefficiencies in the advancement on new treatments.
TransCelerate identified the opportunity for a platform that would enable participating Member Companies to securely share both nonclinical and clinical data. Such a platform could support researchers as they make decisions on compound progression, design and conduct future clinical trials, and establish a greater understanding of patient populations. The platform would serve as a centralized and secure data repository for participating researchers, many of whom are working to find therapies for similar disease areas.
TransCelerate’s Data Sharing Platform: DataCelerate®
TransCelerate built a secure, cloud-based platform that allows the collaborative sharing of R&D data for specified use cases such as study design, geographical or sub-population understanding, and control arm supplementation. The platform is built to scale and extend, comprised of individual modules that act as separate repositories for new data types. It is also 21 CFR Part 11 compliant, a validated system enabling the use of shared data in future regulatory submissions.
Our platform – DataCelerate® – is built on an agile framework that is flexible enough to unlock new approaches to data across the research and development community. DataCelerate® provides standard functionality for structured and unstructured data ingestion, search and export capabilities, and visualization for select data types. Data contribution and use are governed by module-specific legal, privacy and governance frameworks to ensure responsible handling of personal data. The clinical modules in the platform current contains data from more than 95,000 patients who previously participated in various trials.
TransCelerate’s data sharing platform and initiatives have helped re-imagine the ecosystem’s approach to data transparency overall, from one of treating data as a siloed and propriety resource to acknowledging that openness across the ecosystem will advance new therapies faster, especially for patients who require life-saving treatments. Increasing use of the DataCelerate® solution has come at a time when our Member Companies have taken new steps toward increasing their utilization of a broad range of new data types during R&D, including real world data, externally-sourced trial data from other initiatives (e.g., Vivli, CSDR), and genomics. Particularly in 2020 in the context of the global COVID-19 pandemic with various researchers scrambling to identify new vaccines and treatments, greater openness to sharing information across entities is vital.
The Future of Historical Data Sharing
As data from diverse and novel sources become more widely accessed and acceptable to researchers, we anticipate that data from historical clinical trials, electronic health records, consumer wearable devices and other sources will become more commonly used to derive clinical insights to drive development of new therapies for patients globally. Data shared across the clinical development ecosystem can aid in unlocking new models of development, supplement data being collected during trials, and provide a more holistic understanding of patient populations across various therapy areas. We at TransCelerate are committed to supporting our member companies to take a collaborative approach to sharing data, furthering our collective goal of quickly developing new therapies and medicines to improve patients’ lives.
Stay tuned for our next post in the series, which will delve deeper into our data sharing efforts.
By Virginia Nido, Global Head, Industry Collaborations, Roche