How Medidata Link is Supporting Moderna’s Clinical Trial Real-world Data Linkage Initiatives
Investigators gain deeper insights into treatment outcomes when linking their clinical trial data to real-world data (RWD) at the participant level. RWD can provide additional evidence on benefits, risks, and cost of care, ultimately accelerating participants’ access to potentially life-saving treatments while lowering the administrative and financial burden of clinical trials. To evaluate the real-world effectiveness of their mRNA respiratory syncytial virus (RSV) vaccine (currently being studied in a pivotal phase III randomized clinical trial), Moderna launched a real-world longitudinal study.
In the RSV Outcomes Study Extension (ROSE), Moderna aims to leverage linked RWD to examine additional clinical and economic outcomes that are not included in the RSV vaccine Phase III trial. This extends the length of follow-up to study the long-term effectiveness of the vaccine. To achieve this study objective, Moderna partnered with Medidata to connect the trial with participants’ RWD using Medidata Link.
“Medidata Link provides a simple and powerful solution,” says Mehdi NajafZadeh, PhD, Senior Director of Medidata AI. “You can seamlessly integrate with your existing clinical trial workflows, and obtain participant consent to connect their trial data to their insurance claims, EHR, registries, or other RWD sources. This will provide a deeper insight on outcomes to support regulatory and payor discussions—all with minimal burden to participants, sites, and the sponsor.”
Early results of ROSE show that participant interest in linking their RWD to the trial was high, with Moderna reaching an enrollment of 11,000 consents between September 2022 and April 2023.
The Medidata Link team has experienced similar results for other sponsor trials, helping to demonstrate the feasibility of design and implementation of linking clinical trials to real-word data. We have seen very high acceptance from patients who participate in trials, with consent rates above 90%, and exponentially growing interest from sponsors to integrate this solution into their standard trial design. Administrative burden was minimized with seamless integration of linkage sub-studies into standard electronic data capture systems & easy adoption by clinical site investigators and staff via comprehensive training modules.
“The data that we are seeing is proof that clinical trial to real-world data linkage is viable,” says Mehdi. “We see very high acceptance from trial participants, as well as exponentially increasing interest from sponsors to integrate this solution into their standard trial design.”
Findings of the studies “Moderna’s Respiratory Syncytial Virus (RSV) Outcomes Study Extension (ROSE)” and “Enhancing Randomized Controlled Trials By Linking Them To Real-World Data” were presented at the International Society of Pharmacoepidemiology (ICPE) Annual Meeting on August 23–27, 2023 in Halifax, Canada.
About Medidata Link
Medidata Link enables linkage between clinical trial data to real-world data at the participant level to enhance evidence generation beyond what is possible in traditional clinical trials. By creating an enriched view of the patient journey before, during, and after trial completion, Medidata Link generates insights that support the acceleration of clinical development and commercialization.
To break down data silos and connect trials to the largest US-based RWD ecosystems, Medidata Link seamlessly integrates into existing workflows to manage the process for obtaining consent and personally-identifying information (PII)—all while minimizing burden for patients with dedicated documentation developed with the expertise of our Patient Design Studio.
Download our eBook to learn more about the benefits that trials experience from clinical data linkage:
RSV Outcomes Study Extension (ROSE): Epidemiological and Operational Considerations for an Observational Study Linking Real-World Data Through Tokenization to the mRNA-1345 RSV Vaccine Phase 3 Clinical Trial Data in Older Adults:
Catherine A. Panozzo, Diana Latti, Katherine Kacena, Nicholas Paine, Mindy Gruba, Shradda Mehta, Tianyu Sun, Lei Zhu, Qing Xiao, Maureen Maunsell, Andrea Feller, Imy Chiu, Laila El Asmar, Jessica Perry, Sonia K. Stoszek, Grace Chen, Xiao Shao, Runa Mithani, Clementine Semanaz, Nan Shao, Parinaz Ghaswalla
Enhancing Randomized Controlled Trials By Linking Them To Real-World Data:
Najafzadeh M; Shimamura A, McConnochie B; Polewaczyk J; Demirci S; Talwai A; Ahmed A; Chatterjee A.
Additional Key Medidata Contributors:
Saira Niamathullah, David Saunders, Ana Fernandez Oromendia