Medidata, TriNetX, and Datavant announced a partnership that will accelerate the use of real-world data (RWD) to power clinical research. /This partnership will enable users of Medidata’s end-to-end clinical research platform to securely link their clinical data with patient consent to de-identified patient data without unblinding the study. The solution leverages Datavant’s Patient Key technology and data ecosystem, as well as RWD from TriNetX’s global network of healthcare organizations who participate in this program. Pooling and integrating disparate datasets to form a complete picture of the patient experience can create insights to inform decision-making across the product life cycle, from R&D to pre-launch to post-launch. Real world treatment patterns are also used to inform novel therapy development and adoption. Pooled clinical trial data is increasingly being used to design synthetic control arms, and even to power algorithms that can predict things like patient drop out. The Medidata, TriNetX, and Datavant partnership will enable use of RWD throughout all phases of clinical development: For new therapies where trials have not yet begun: Clinical trial sponsors can better validate the patients enrolling in their trial, During trials: Sponsors can enhance safety monitoring, build external control arms, and enrich and accelerate understanding of their patients via hybrid studies, where traditional randomized controlled clinical studies add pragmatic RWD collection and After the completion of a trial: Drug safety and efficacy of their drugs in the trial cohort (preserving the randomization of the trial design) can be tracked easily without manual patient follow up; sponsors can also generate a data feedback loop to better design future trials. RWD linkage will be particularly valuable for the clinical trials conducted for COVID-19 to support the collection of additional safety and surveillance data. Patients enrolled in a clinical trial utilizing Medidata’s solutions will have the option to grant consent for their data to be linkable using Datavant’s de-identified Patient Keys to both TriNetX’s broad RWD assets and Datavant’s open data ecosystem. This enables sponsors to cost-effectively study the efficacy and safety of their therapies for many years after the completion of the trial with less risk of losing patients to follow-up. The clinical trial and real-world data ecosystems are complex, and enabling the incorporation of real-world data at scale will require cooperation among a large number of players across the industry including sponsors, contract research organizations, technology platforms, data originators and aggregators, and analytics companies. In order to enable the connection of clinical trial data and real-world data, Medidata, TriNetX and Datavant are pursuing an open, partnership-first approach and look forward to continued collaboration across the industry to modernize the clinical trial infrastructure for patient benefit.