Dassault Systemes

Medidata Institute

The Medidata Institute

Welcome to the Medidata Institute, a hub for our latest thinking on how collaborative clinical trial data, technology, and expertise can improve patient lives and inspire the next generation of treatments.

Papers and Publications

2023 Publication
Better Data, Better Decisions: Achieve greater certainty in clinical trial financial management by leveraging adaptive, accurate, and defendable fair market value
2023 Publication
An interpretable data augmentation framework for improving generative modeling of synthetic clinical trial data
2022 Publication
CXCL13 is a predictive biomarker in idiopathic multicentric Castleman disease
2022 Publication
Phase IB Trial Efficacy Estimates via a Clinical Trial Synthetic Control Arm
2022 Publication
JBS: Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer
2022 Publication
Statistics in Biosciences: Building an External Control Arm for Development of a New Molecular Entity: An Application in a Recurrent Glioblastoma Trial for MDNA55
2021 Publication
Towards an extensible ontology for streaming sensor data for clinical trials
2021 Publication
EUCROF and eClinical Forum Task Force: Electronic Informed Consent Implementation Guide
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Presentations and Webinars

2020 Webinar with Health Verity
The Emerging Role of RWE: Longitudinal Patient Insights to Bridge the Clinical and Real World
2020 Conference Presentation
PMWC: “Clinical Trials in the Era of COVID-19” with Fareed Melhem
2020 Conference Presentation
HMS DBMI Precision Medicine: “What is the Path to Industrialization?” Panel with Arnaub Chatterjee
2020 Webinar
Lazarex Cancer Foundation & Medidata on Disrupting the System III: A Provocative Discussion to Spark Positive Change
2020 Webinar
Clinical Trial Data Meets the Real World: Bridging the Experimental and Post-Launch Worlds
2020 Webinar
HMS Exec Education: “Synthetic Control Arms in Clinical Trials and Regulatory Applications” with Arnaub Chatterjee
2019 Conference Presentation
HMS DBMI Precision Medicine: “Is There Value in Prediction?” Panel with Arnaub Chatterjee
2019 Conference Presentation
PhUSE: Using Synthetic Control Databases to Accelerate Indication-Specific Safety and Efficacy Evidence
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Insights and Perspectives

2020 COVID-19 Resources
COVID-19 Research Database Study Results
2020 Industry Insights
COVID-19 Puts Spotlight on Artificial Intelligence
2020 Industry Insights
Medidata Analysis Shows COVID-19 Impact on Trials
2020 Article
Pharmaforum: National Minority Health Month: the importance of diversity in clinical trials
2020 COVID-19 Resources
Medidata Participates as Judge at COVID-19 Data Hack with AppliedXL, The Boston Globe and STAT News
2020 Industry Insights
Advancing ALS Research With Omics Analysis Technology
2019 Report
Newsweek Vantage report on Precision Medicine: Creating Value for Everyone
2019 Article
Applied Clinical Trials: The Cancer Trial Paradox – Too Few Patients to Some Too Few Trials for Others
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Conference Abstracts and Posters

2024 Poster
Pooled Clinical Trial Data Analyses Comparing the Biology of HER2-low vs HER2-0 Breast Cancer in Patients with Metastatic Breast Cancer Following Treatment with Standard Single Agent Chemotherapy
2024 Poster
Phosphorus disruption is associated with the incidence and severity of neurotoxicity symptoms in CD19-targeted CAR T-cell therapy: a pooled clinical trial analysis
2024 Poster
Machine Learning-Based Decision Tree for Identifying and Grading Severity of ICANS Based on Neurological Adverse Events in Patients Treated with CD19 CAR T-Cell
2024 Poster
Significant Cytokine Release Syndrome Risk Model With T-Cell Engaging Therapies
2023 Poster
Research Hub Framework: Optimizing T-Cell Redirecting Therapies Through Multi-Sector Collaborations and Data
2023 Poster
PMSA May 2023 Poster Tree Based Marketing Mix Models
2023 Poster
EHA CAR T-cell Meeting: Co-occurrence patterns of CRS and ICANS in patients undergoing autologous CD19-targeted CAR T-cell treatments
Brain Metastases in Patients with KRAS Mutant Advanced NSCLC Receiving Docetaxel: Pooled Clinical Trial Data Analysis
2021 Poster
NEALS: CA3 levels in plasma associate strongly with site of onset in ALS
2021 Abstract
ASCO: Assessment of Vitamin D deficiency and COVID-19 diagnosis in patients with breast or prostate cancer using Electronic Medical Records
2021 Abstract
ASCO: Oncology trial enrollment trends following the first wave of the COVID-19 pandemic.
2021 Poster
ASCO: Assessment of Vitamin D deficiency and COVID-19 diagnosis in patients with breast or prostate cancer using Electronic Medical Records
2021 Poster
ASCO: Oncology Trial Enrollment Trends Following the First Wave of the COVID-19 Pandemic
2020 E-Poster
ASH: Racial Differences in Multiple Myeloma Survival Using Clinical Trial and Real-World EMR Data
2020 Abstract
ASH: Racial Differences in Multiple Myeloma Survival Using Clinical Trial and Real-World EMR Data
2020 Poster
ISPOR EU: Treatment Patterns of Antihypertensive Medications Among Alzheimer’s Disease Patients in United States and Europe  
2020 Poster
ISPOR EU: Healthcare Resource Utilization Among Alzheimer’s Disease Patients Using Antihypertensive Medication in United States and France
2020 Poster
ISPOR EU: Identifying the Baseline Characteristics of Heart Failure Patients That Receive and Do Not Receive the Seasonal Influenza Vaccine
2020 Poster
ISPOR EU: Clinical and Demographic Factors Associated with Prescribing Disease Modifying Agents in Multiple Sclerosis Patients 
2020 Poster
ESMO: Does Race Impact Outcomes in Triple Negative Breast Cancer?
2020 Abstract
AACR: COVID-19 Pandemic Slows Launch of Oncology Clinical Trials
2020 E-Poster
AACR: COVID-19 Pandemic Slows Launch of Oncology Clinical Trials
2020 Abstract
ASCO: Exploring the validity of a SCA in difficult-to-study indications: A case study in relapsed/refractory multiple myeloma
2020 Abstract
ASCO: Evaluating progression-free survival in black and white women with breast cancer in pooled clinical trials from a synthetic control database and real-world EMR
2020 Abstract
ASCO: Assessing the relationship in relapsed-refractory multiple myeloma between pooled clinical trial subjects and a real-world EMR data source
2020 Abstract
ASCO: Error-free, automated data integration of exosome cargo protein data with clinical data in an ongoing, multi-omic translational study
2020 Presentation Abstract
JSM: Data Standardization to Facilitate Comparison of Real World Data and Clinical Trial Data
2020 Poster Abstract
JSM: Bayesian Synthetic Control Approaches in Pediatric Drug Development in ALL
2019 Poster
ASCO: Results of a Randomized Control Arm are Replicated by a Synthetic Control Arm in NSCLC
2019 Poster
ISPOR EU: Prescription Pattern and Physician Propensity for CHF Treatments in US and EU
2019 Poster
ISPOR EU: Health Resource Utilization in Advanced Ovarian and Endometrial Cancer in a United States Insurance Claims Database
2019 Poster
ISPOR EU: Using Clinical Data Standards to Facilitate Comparisons of AML Treatment Patterns and Outcomes in Real-World Clinical Care and Pooled Clinical Trial Populations
2019 Poster
ISPOR EU: Patterns and Prediction for Cognitive Decline in Alzheimer’s Patients Assessed by the Mini-Mental Status Exam in an Ambulatory EMR
2019 Poster
ISPOR EU: Evaluation of Missing Data Imputation Strategies in Clinical Trial and EMR Data Using Standardized Data Models
2019 Poster
ISPOR EU: 3C-HF Prognostic Score to Predict Worsening Cardiac Function Among Congestive Heart Failure Patients in United States and Europe
2019 Poster
ISPOR EU: Scalable Prediction of Cancer Patient Clinical Events in Real-World Clinical Settings
2019 Poster
ISPOR US: Persistence to oral and injectable multiple sclerosis disease-modifying therapies
2019 Poster
ISPOR US: A Systematic Approach For Synthetic Replication Of Clinical Trial Cohorts Using Retrospective Real-world And Clinical Trial Data
2019 Poster
ISPOR US: A Systematic Approach For Quantifying Heterogeneity Within Clinical Trial Populations
2019 Poster
ISPOR US: Predicting Chemotherapy-associated Thrombocytopenia In Real World Clinical Settings
2019 Poster
ISPOR US: Real World Replication Of Clinical Trial Findings In Alzheimer’s Disease
2019 Poster
ASH: Quantitative Changes in Serum Proteins are Early Indicators of Response to Anti-IL6 Therapy in Idiopathic Multicentric Castleman Disease
2020 Abstract
JSM: Bayesian Synthetic Control Approaches in Pediatric Drug Development: A Case Study in ALL
2019 Poster
PSI Best Poster Award: Using Synthetic Control Databases to Accelerate Indication-Specific Safety and Efficacy Evidence
2019 Poster Abstract
DIA: Using Synthetic Control Databases to Accelerate Indication-Specific Safety and Efficacy Evidence
2019 Poster
DIA: Using Synthetic Control Databases to Accelerate Indication-Specific Safety and Efficacy Evidence
2018 Poster
ASH: Serum Proteomics Reveals Distinct Subtypes Associated with Treatment Response in Idiopathic Multicentric Castleman Disease
2017 Abstract
ASCO: Creating a synthetic control arm from previous clinical trials: Application to establishing early end points as indicators of overall survival in AML
2017 Poster
SOCRA: The use of Electronic Informed Consent (eConsent) in a Blood Collection Study
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