Medidata Research Alliance
Fueled by Medidata’s platform to power smarter treatments and healthier people, the Medidata Research Alliance was created to propel our scientific research initiatives further.
The mission of the Medidata Research Alliance is to cultivate collaborative relationships throughout the scientific, technology, and medical research communities. Our primary goal is leveraging historical clinical trial data to advance medical breakthroughs and expand patients’ access to the most promising treatments. This mission is achieved through our exclusive framework that brings together academic key opinion leaders with the Medidata team’s extensive data and technology expertise.
The Future of Medical Research
The Medidata Research Alliance brings together academic and key opinion leaders with Medidata’s expert staff, comprised of clinicians, biostatisticians, former regulatory officials and industry veterans. By combining multi-sector expertise with data-driven research, we advance clinical innovations and fulfill our mission of powering smarter treatments and healthier people.
Leveraging data & analytics
Our collaborative research is powered by historical clinical trial data from over 30,000 cross-sponsor trials with more than 9 million patients from over 100 countries. These data come complete with the original endpoints and complete covariate information, validated in the Medidata Rave electronic data capture (EDC) platform. This enables in-depth research and analytics to help uncover trends in diverse patient populations, and evaluate therapeutic efficacy, patient outcomes, and safety profiles-, all while ultimately fueling advancements in research, treatment strategies, and medical progress.
Accelerate Medical Breakthroughs
The Medidata Research Alliance explores clinically impactful hypotheses to bridge insights from data to clinical practice. Our work has focused on immunotherapies and rare diseases and serves as successful models for expanding into additional therapeutic areas.
We have co-presented with our Research Alliance partners at global conferences such as ASCO, ASH, NCCN, and EBMT-EHA on topics including:
- The understanding and clinical management of severe side effects associated
- Identifying patient cohorts most likely to respond to investigational therapies (ie, Castleman disease)
- Improving understanding of diagnostic biomarkers in rare diseases (ie, ALS)
- Using clinical trial and real world data to accelerate breakthroughs in public health topics (ie, COVID)
Learn more about the key elements of the Medidata Research Alliance.
Leverage Robust Data
Leverage powerful AI modeling and generate insights by connecting data from over 30,000 cross-sponsored historical trials with more than 9 million patients from over 100 countries. These data come complete with the traditional endpoints and complete covariate information, as they were captured in the Medidata Platform. This exclusive data source enables data-driven clinical research, allowing for a more thorough exploration of trends and patterns to advance scientific and medical progress.
Our highly qualified team of experts are your collaborative partners who work as an extension of your team. The Medidata AI team includes subject matter experts and clinician-researchers with deep industry, regulatory, data science, and medical expertise.
At the core of the Medidata Research Alliance lies a commitment to advancing quality clinical research through our proprietary framework. This collaborative, scalable framework is the foundation for uniting leading academics and research scientists with our industry experts in data and technology. Medidata actively engages with our partners through collaborative analyses to turn hypotheses into actionable insights that expand the boundaries of medical knowledge and clinical trial innovation.
Synthetic Control Arm® (SCA®)
Build an external control arm to generate evidence and identify relevant data points from historical clinical trials that can serve as “ground truth” for regulatory submissions or for designing your clinical development programs. Run scenarios to identify the right data points to optimize your clinical trial design. Reduce uncertainty, reduce timelines, and get to go/no-go decisions faster.
Trial Design offers historical clinical trial data, and synthetic data derived from this exclusive data source, to help clinical development teams make more informed decisions to accelerate medical breakthroughs and create safer, effective clinical trial designs.
Medidata Link offers the only centralized, CRO-agnostic solution that allows sponsors to collect clinical trial data and link it at the patient level to multiple RWD sources without adding additional burden to sites and patients — bridging evidence gaps to save time and feel more confident in their decision making.
The Medidata Institute
The Medidata Research Alliance builds upon earlier work and existing partnerships with key clinicians and researchers from academia, industry leaders, and leading data scientists to conduct cutting-edge research to improve the field’s understanding of therapies.
The Medidata Institute is a comprehensive library of research and publications from Medidata and its collaborators, with work including:
- NEALS 2021: CA3 levels in plasma associate strongly with site of onset in Amyotrophic Lateral Sclerosis (ALS)
- ASCO 2021 Assessment of Vitamin D deficiency and COVID-19 diagnosis in patients with breast or prostate cancer using Electronic Medical Records
- APHA 2021: Vitamin D deficiency: Risk of COVID-19 and public health implications
- ASH 2019: Quantitative Changes in Serum Proteins Including CXCL13 Are Early Indicators of Response to Anti-IL6 Therapy in Idiopathic Multicentric Castleman Disease
- ASH 2018: Serum proteomics reveals distinct subtypes associated with treatment response in idiopathic multicentric Castleman disease
Medidata AI offers the largest available database of CAR-T and Bi-specific T-cell Engagers (BiTEs) therapies, made up of over 70 cross-sponsor trials for approved or investigational therapies.
These data are not only leveraged for commercial applications, including helping sponsors to design clinical trial protocols that help inform safety events or patient selection, but have been leveraged by our academic partners to show relationships between commonly collected lab data and the likelihood of adverse events.
Our work has been widely featured in peer-reviewed journals, medical conferences, and the press:
- ASCO 2022: Predictors of severe CRS in longitudinal CAR T-cell clinical trial data
- ASH 2022: Predictors of severe CRS in longitudinal CAR T-cell clinical trial data
- EHA 2023: Co-occurrence patterns of CRS and ICANS in patients undergoing autologous CD19-targeted CAR T-cell treatments
- FierceBiotech: Medidata links CAR-T’s cytokine release syndrome risk to common biomarkers in new study
Medidata has historical clinical trial data from 100,000+ patients that have been studied for MACE (Major Adverse Cardiovascular Events) such as stroke, myocardial infarction or heart attack, or heart failure. This includes patients who suffer from multiple comorbid conditions such as diabetes, obesity, hypertension, hyperlipidemia, and chronic kidney disease. Our data has a long follow-up time of up to six years, which is key to generating regulatory grade evidence. This dataset captures the most recent classes of drugs such as PCSK9, NOACs/DOACs, SGLT2, GLP1, and other standard-of-care therapies.
This data has been used in cutting-edge research including:
- ISTH 2021: Comparing the Real-world and Clinical Trial Bleeding Rates Associated with Anticoagulation Treatment for Atrial Fibrillation
- DDW 2022: Real-World Comparison of Healthcare Resource Utilization between Transoral Incisionless Fundoplication and Laparoscopic Nissen Fundoplication for the Treatment of Gastroesophageal Reflux Disease
- DDW 2022: Real-World Comparison of Characteristics of Patients Who Received Transoral Incisionless Fundoplication vs. Laparoscopic Nissen Fundoplication for the Treatment of Gastroesophageal Reflux Disease
- ISPOR 2023: Validation of Novel Identification Algorithms for Nonfatal Myocardial Infarction Using Uniform Objective Criteria and Pooled Clinical Trial Data
Medidata offers synthetic patient-level data that is derived from historical clinical trial data. This offers teams the ability to harness the insights and power of historical clinical trial while preserving patient privacy. This offers unparalleled opportunities for data sharing, cross collaboration, and innovation.
- ICML 2023: An interpretable data augmentation framework for improving generative modeling of synthetic clinical trial data
- Neurips 2022: A Source Data Privacy Framework for Synthetic Clinical Trial Data
- Neurips 2022: Synthetic Clinical Trial Data while Preserving Subject-Level Privacy
- _synthesize 2023: Synthetic Data Revolutionizing Clinical Trial Data Collaboration and Research