Yale University-Mayo Clinic CERSI
The Yale-Mayo CERSI conducts high-quality, high-impact collaborative research to support several areas of focus in the FDA strategic plan for regulatory science. Research topic areas include: advancing clinical and post-market surveillance of drugs and biologics, advancing clinical and post-market surveillance of medical devices and diagnostic tests, development and application of novel analytics, and fostering patient-centered decision making.
For comments or questions pertaining to our CERSI research projects, contact the Yale-Mayo Clinic CERSI at CERSI@yale.edu.
Current Projects
Modernizing Development, Evaluation, and Post-Market Surveillance of Drugs and Biologics
- Characterizing use, safety and efficacy of brand-name and generic drugs used to treat hypothyroidism
Project Details: To characterize usage patterns of brand-name and generic levothyroxine products and compare their effectiveness and safety among new users of the medications site
Project Results:
- Use of instrumental variable approaches to assess the safety and efficacy of brand-name and generic drugs used to treat hypothyroidism
Project Details: To test instrumental variable methods for comparing the effectiveness and safety of brand-name and generic L-thyroxine using large administrative claims data, and to develop toolkits supporting the implementation of these methods in future research.
Project Results: Project complete; no public results
- Linking data sources to elucidate non-fatal and fatal opioid-related overdose epidemiology and the role of FDA-regulated products
Project Details: To link Connecticut state-level datasets to assess patterns of FDA-regulated medication receipt and service utilization prior to opioid-related overdoses; to evaluate concordance between prescription records and post-mortem toxicology; and to examine associations between demographics, prescription history, and treatment engagement with subsequent risk of fatal and non-fatal overdose
Project Results:
- Characterization and analysis of high incidence of potentially unsafe prescribing of some Extended-Release (ER) opioid analgesics using Natural Language Processing (NLP) of Electronic Health Record (EHR) clinical notes
Project Details: To determine the frequency of inappropriately prescribing extended-release opioid analgesics requiring prior opioid tolerance to non-tolerant patients, and to analyze prescribing behaviors by exploring free text fields within the patients’ electronic health records with natural language processing among those identified as being non-opioid tolerant but are receiving a higher dosage opioid prescription.
Project Results:
- Understanding the contribution of laboratory data linked to administrative claims: a case study looking at renal function and oral anticoagulant performance in patients with atrial fibrillation
Project Details: To assess the effectiveness and safety of oral anticoagulants across different levels of kidney function in patients with atrial fibrillation.
Project Results:
- Characterizing safety and efficacy of brand-name and generic drugs used to treat hypothyroidism among patients who switch therapy formulation
Project Details: To examine rates and factors associated with switching between generic levothyroxine products within one year of treatment initiation, and to compare thyrotropin stimulating hormone levels among patients who switch versus those who remain on the same sourced product.
Project Results:
- Real-world data to assess variation in opioid prescribing and use for acute pain in diverse populations
Project Details: To assess patients’ pain levels and persistence, functional outcomes, and use of prescribed and over-the-counter pain medications after acute pain episodes; to examine how demographic, clinical, and emotional factors relate to pain and opioid use over time in diverse populations; and to determine how patients handle unused opioids.
Project Results:
Acute pain pathways: protocol for a prospective cohort study (2022)
- Quantifying the relationship between inappropriate prescribing of opioid-tolerant-only medications to patients without prior opioid tolerance and opioid-related harms
Project Details: To measure the risk of opioid-related harms associated with inappropriately prescribing opioid-tolerant-only medications to individuals who do not meet the opioid tolerance requirements, using medical billing and mortality data, and to identify factors associated with these harms.
Project Results:
Pending
- Trends in opioid use among patients with cancer
Project Details: To assess trends in receipt of new opioid use and new persistent opioid use among patients with cancer by conducting population-level analysis and health system analysis, across distinct cancer stages and treatment scenarios
Project Results:
Trends in new and persistent opioid use in older adults with and without cancer (2024)
- Sex differences in immune profiles of PASC before and after vaccination
Project Details: To investigate sex differences in immune responses and symptoms among individuals with Long COVID before and after vaccination, and to compare them to those in individuals with prior COVID-19 but without Long COVID.
Project Results:
Pending
- A mixed methods research design to identify factors influencing prescriber decision-making about pain management and opioid prescribing
Project Details: To identify factors influencing prescriber decision-making about opioid pain medication through interviews and focus groups with healthcare providers, and to develop a survey that measures how providers make decisions about prescribing opioid pain medications.
Project Results:
Pendiing
- Prescription Stimulants for Attention-Deficit/Hyperactivity Disorder (ADHD): Prescribing Patterns and Associated Consequences in the Veterans Health Administration[JR1] [JR1]**NEW please add
Project Details: To characterize stimulant prescribing patterns among adults with ADHD, identify associated patient- and facility-level factors, validate structured data to identify ADHD and stimulant use disorder, and assess its related risks.
Project Results:
PendingTBD
Modernizing Development, Evaluation, and Post-Market Surveillance of Medical Devices and Diagnostic Tests
- Post-market surveillance with a novel mHealth platform
Project Details: To explore whether a new mobile health technology that integrates patient-reported outcomes, wearable device data, electronic health records, and pharmacy data can support FDA post-market surveillance of medical devices
Project Results:
- Real world short- and intermediate-term safety outcomes following atrial fibrillation ablation
Project Details: To use real-world claims data to characterize short- and intermediate-term complication rates of atrial fibrillation ablation, with an emphasis on atrioesophageal fistula
Project Results:
- Implementation of a stakeholder survey to facilitate enhanced pediatric medical device innovation
Project Details: To implement a stakeholder survey to assess how the current regulatory environment influences business decision-making, particularly for medical devices for pediatric and special populations, and to identify strategies that incentivize innovation and foster a supportive marketplace for technologies that improve their care.
Project Results:
Pending
- Identification of FDA-approved devices using Unique Device Identifiers (UDIs) from routinely collected electronic medical record data[MB1] [MB1]**New, please add
Project Details: To characterize Class I medical device recalls and to evaluate whether recall notices include complete Unique Device Identifiers to support effective identification and management of recalled devices.
Project Results:
- Evaluating mobile health tool use for capturing patient-centered outcome measures in heart failure patients
Project Details: To evaluate the feasibility of using mobile health platforms, including smartphones and wearable devices, to capture functionality, symptoms, continuous activity levels, and quality of life measures in patients with heart failure.
Project Results:
Pending
- Standardizing multi-model data for the diagnosis and prognosis of coccidioidomycosis as a model for establishing harmonized core data for additional infectious diseases
Project Details: To measure how closely a prototype rapid antibody test can approximate the traditional methods used to measure titers of antibodies against Coccidioides and identify the most informative combinations of clinical data for diagnosing, monitoring, and treating coccidioidomycosis
Project Results:
Pending
- Redefining the paradigm for Lyme disease diagnosis and therapeutics
Project Details: To develop and publicly release a LymeX data schema for Lyme disease diagnostics to support clinical trials and documentation of the broad manifestations of all stages of Lyme disease
Project Results:
Pending
Development and Application of Novel Analytics
- Utilization and adverse events associated with mechanical circulatory support devices among patients with acute myocardial infarction and cardiogenic shock undergoing PCI
Project Details: To characterize utilization patterns and adverse events associated with different mechanical circulatory support devices in cardiogenic shock patients undergoing PCI, and to identify distinct subgroups within this patient population.
Project Results:
- Understanding the use of existing real-world data for medical product evaluation
Project Details: To better understand the potential advantages and limitations of applying observational research methods to real-world clinical data to emulate the populations and results of ongoing clinical trials used for FDA regulatory evaluations.
Project Results:
- Bayesian adaptive basket trial designs for neoantigen based immunotherapy with borrowing strength across subpopulations within the trial and from external controls
Project Details: To develop and evaluate the validity of Bayesian basket trial designs borrowing information across subpopulations within neoantigen-based immunotherapy trials and from external controls.
Project Results:
Pending
- Informatics driven real world analysis of SARS-CoV-2 serologic response and in vitro diagnostic accuracy
Project Details: To implement real-time identification of specimens for clinical serologic test validation and to characterize the antibody response to SARS-CoV-2 infection and the performance of serologic assays over time.
Project complete; no public results
- Evaluate application of artificial intelligence to adaptive enrichment clinical trials
Project Details: To evaluate the applicability of AI-identified treatment outcomes during trial progression to predict treatment effect heterogeneity at trial completion, and to assess the use of AI-based adaptive strategies for mid-course trial enrichment and modification of enrollment criteria.
Project Results:
Pending
- Identifying, selecting, and utilizing quantitative bias analysis methods
Project Details: To identify, compare, and evaluate quantitative bias analysis methods for observational studies, develop a user-friendly decision tree to guide method selection, and assess its feasibility using published research.
Project Results:
- Community-level emerging substance misuse simulation
Project Details: To analyze polydrug use prior to concurrent use of specific non-opioid drug classes as influences on timing and likelihood of use transitions and outcomes, and to simulate naloxone use patterns and harm reduction strategies across varying naloxone products, distribution strategies, opioid types, populations, and bystander involvements.
Project Results:
Pending
- Evaluate the application of machine learning algorithms to the management of postpartum hemorrhage
Project Details: To determine the sources of variation in postpartum hemorrhage management across different populations of women using machine learning algorithms; to evaluate their associations with patients’ clinical and sociodemographic factors; and to assess links between management patterns and severe maternal outcomes.
Project Results:
Pending
- Real-world outcomes of novel PET imaging tracers for prostate cancer
Project Details: To evaluate how PSMA-PET imaging influences short-term clinical decisions related to prostate cancer staging, monitoring, and treatment, and to model its long-term effects on treatment duration, side effects, quality of life, and survival outcomes.
Project Results:
- Development of optical and digital microscopy hardware, software, and statistical methods to enable computational pathology in low resources
Project Details: To develop and integrate low-cost optical and digital microscopy tools, software, and statistical methods to enable remote and AI-supported computational pathology in low-resource environments, and to generate reference data for evaluating immune cell density scoring tools.
Project Results:
- A machine-learning model to identify women with anti-nuclear antibody related connective tissue diseases
Project Details: To develop and validate a machine learning model using real-world electronic health record data to identify individuals with anti-nuclear antibody related connective tissue diseases among those who test positive on ANA screening.
Project Results:
Pending
Fostering Patient-Centered Decision Making
- Qualitative analysis of gender differences in heart failure PROs
Project Details: To conduct qualitative analysis to understand gender-based differences in interpretation and response to the Kansas City Cardiomyopathy Questionnaire among patients with heart failure and to improve its validity and clarity for female patients.
Project Results:
- Methods to capture post-market patient preference information
Project Details: To design and compare between three methods- a direct from encounter method and two immediately post-encounter methods- for identifying patient preferences that influence real-time decisions about using marketed medical products
Project Results:
- Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study
Project Details: To evaluate and compare clinician-reported, patient-reported, and wearable device-based methods for measuring physical function in patients with cancer undergoing chemotherapy, including associated challenges, burden, and usability, and to examine how longitudinal changes in physical function relate to the likelihood and severity of chemotherapy side effects.
Project Results:
- Patient and provider informed labeling of AI/ML-based software to enable transparency and trust
Project Details: To develop and pilot-test a dynamic, patient-centered digital labeling approach for AI/ML-based medical devices to assess patient acceptance, usability, and comprehension.
Project Results:
Trustworthy and ethical AI-enabled cardiovascular care: a rapid review (2024)
- Improving the diagnosis and treatment of women with myocardial ischemia and no obstructive coronary artery disease
Project Details: To develop and validate a patient-reported outcome measure to assess the overall health status in women with myocardial ischemia and no obstructive coronary arteries (INOCA), and to evaluate its validity across specific INOCA subtypes.
Project Results:
Pending
- Qualitative techniques to define meaningful within-patient change in symptoms of advanced cancer patients
Project Details: To define meaningful within-patient change in symptoms and side effects among advanced cancer patients using qualitative methods, and to evaluate a patient-centered approach for interpreting changes in selected patient-reported outcome measures.
Project Results:
Pending
- A positive deviance approach for representing women, older adults and patients identifying as racial and ethnic minorities in oncology research
Project Details: To identify and qualitatively assess shared strategies used by trial sponsors to perform exceptionally in enrolling diverse and representative participants in cancer research, using a positive deviance approach
Project Results:
Pending
- Longitudinal analysis & visualization of patient-reported physical function & symptom data
Project Details: To analyze and visualize patient survey data on physical function and side effects from rare cancer clinical trials, and to obtain initial feedback from patient advocates, clinicians/clinical investigators, and FDA decision makers on these visualizations.
Project Results:
Pending