What You Should Know:
– Today, Medidata, TriNetX, and Datavant announced a partnership to accelerate the use of real-world data (RWD) to power clinical research.
– Linking RWD, which is data not collected during the specific context of a clinical trial, can help improve understanding of the long-term safety and efficacy of new therapies.
Medidata, a Dassault Systèmes company, TriNetX, and Datavant announced a partnership that will accelerate the use of real-world data (RWD) to power clinical research. Linking RWD, which is data not collected during the specific context of the trial, can help improve understanding of the long-term safety and efficacy of new therapies.
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 that participate in this program.
Why It Matters
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.
Powering Use of RWD Throughout All Clinical Development Phases
The partnership will enable the 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.
– 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.
Value of RWD Linkage
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.
“As the COVID-19 pandemic has demonstrated, the value of real-world data to speed clinical development and understand new potential therapies has never been greater,” said Travis May, Chief Executive Officer of Datavant. “We are thrilled that our technology will support industry leaders Medidata and TriNetX to enable sponsors to connect real-world data for novel analytics while protecting patient privacy. As new vaccines and treatments come to market faster than ever before, the use of real-world data to gather additional safety and efficacy data will be critical to ensuring patient safety and continued evidence gathering.”