CERSI Research Projects
The CERSIs conduct cutting-edge regulatory science research with high public health impact aimed at development of new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Many of these research projects are conducted in collaboration with FDA.
Johns Hopkins University
- Non-invasive Integrative Liquid Biopsy Approaches for Precision Immuno-oncology
- Development of a precision oncology decision support platform to enhance genotype-driven clinical trial recruitment and decentralized personalized medicine approaches
- Defining SARS-CoV-2 vaccine-induced immunity in pregnant and lactating people
- Assessing real world use of pharmaceuticals among pregnant and lactating people
- Active Surveillance of Medical Device Safety and Outcomes Using EHRs: Prostate Cancer Partial Gland Ablation Technologies
- How consumers use flavors to make inferences about Electronic Nicotine Delivery System (ENDS) product qualities and intentions to use? (Phases I and II)
- Using Social Media for Tobacco Regulatory Intelligence
- Assessing Physiological, Neural, and Self-Reported Response to Tobacco Education Messages
- Bulk Drug Substances Used to Compound Drugs for Patients with Autism Spectrum Disorder (ASD)
- Histology, Pathology and Histopathology of Humanized Mice
- Improving the Efficiency and Rigor of Pharmacovigilance at FDA: visualization of multi-source information and unsupervised learning to support causal inference
- Patient and Provider Views on Clinical Endpoints: A Qualitative Preference Study of Minimally Invasive Glaucoma Surgical (MIGS) Devices
- PET Evaluation of Adoptive Cancer Cellular Immunotherapy
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Research Triangle CERSI
- Characterization of the impact of xylazine and dexmedetomidine: pharmacological profile, addictive behaviors, and physiological effects, including wound development
- Enhancing the role of pharmacies in reducing opioid misuse and abuse in racial and ethnic minority and rural communities
UCSF-Stanford University
- A Rapid Query Model to Address Prioritized COVID-19 Questions Using EHR Data
- Large Language Models to support Bioequivalence Evaluation
- Tissue Chips for Multipotent Stromal Cell Manufacturing
- The MUM study: MUltimorbidity and Medications: The unheard perspective of older adults
- Assessing the Potential for Patient-Specific and Genome Edited Induced Pluripotent Cell-Based Models to Streamline Clinical Drug Development for Rare Diseases
- The Real-World Effectiveness of COVID-19 Vaccines in the Pediatric Population Across the University of California Health System
- Role of Genomic Ancestry in Tyrosine Kinase Inhibitor (TKI)-Induced Cardiotoxicity
- Whole exome sequencing to predict immune related adverse events and response to checkpoint inhibitors
- Development of Thrombogenicity Testing Methods for Medical Devices with Large Blood-Contacting Surfaces
- Safe Algorithmic Change Protocols for Modifications to AI/ML-based Software as a Medical Device
- Effects of Antioxidants in Drug Products on Intestinal Drug Transporters
- Characterizing Population-Specific Clinical Asthma Profiles
- An Unbiased Analysis of Identification and Assessment of Cas9/gRNA Potential Off-Target Sites in Clinical Development of Ex Vivo Manufactured Genome Edited Cell Products
- Usability Testing of Virtual Reality for Opioid-Sparing Pain Management Among Diverse Patients
- Real-World Population Characteristics, Safety and Effectiveness of COVID-19 Vaccines
- Improving adverse event detection related to biologic immunosuppressant use – a pilot study of the BERT deep learning model adapted to real-world clinical notes
- Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children
- Prospective Clinical Study of Pulse Oximeter Errors in Adult Hospitalized Patients with Varying Skin Pigmentation
- Using the University of California Clinical Data Warehouse to Evaluate the Safety and Efficacy of Biologics, including Blood Transfusions, Vaccines, CAR-T Cell Therapies, and Other CBER Regulated Products
- Learning Real-World Sex-Specific Clinical Factors Influencing the Susceptibility to Infection, Immune Response, Treatment Utilization and Outcomes Among Individuals Infected with SARS-CoV-2 Infection
- Comprehensive Assessment of Sex-Differential Smoking-related Effects in Publicly Available Gene Expression Data
- Source Data Capture from Electronic Health Records (EHRs): Using Standardized Clinical Research Data (OneSource Phase I)
- Orthopedic Device Mechanics
- Improving the Efficiency and Rigor of Pharmacovigilance at FDA
- Renal Impairment in New Drug Development
- Effects of Excipients in Generic Drugs Products on Intestinal Drug Transporters
- Next Generation Text Analytics for FDA - Relevant Text Mining
- Chemoinformatic Tools to Predict the Effects of Excipients in Generic Drugs
- Comparing Qualitative and Quantitative Approaches to Eliciting Patient Preferences: A Case Study on Innovative Upper Limb Prostheses
- Patient Reported Outcomes for Minimally Invasive Glaucoma Surgery (MIGS)
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University of Maryland
- Phase 1: Development of diagnostic biomarkers for determination of traumatic brain injury
- Physiologically based pharmacokinetic model informed framework to prioritize drugs to be studied in pregnant population
- Hyperspectral Interferometric Scattering Microscopy for Characterizing Nanoparticle-based Therapeutics
- Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products
- An X-Ray Based Online Probe for Real-Time Process Monitoring of The Crystallization of Active Pharmaceutical Ingredients
- Noninvasive Process Analytical Technology (PAT) for Manufacturing Automation
- Understanding Safety Concerns with Intravenous (IV) Misuse and Abuse of Opioids in Deterrent Formulations
- Applying Additive Manufacturing for Continuous Production of Extracellular Vesicle Products
- Metabolism-based drug-drug interactions (DDI) and liver toxicity of drugs for COVID-19 treatment
- Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products
- Precision Medicine Utilizing Bacillus Calmette–Guérin (BCG) Vaccine in Non-Muscle Invasive Bladder Cancer
- An integromic signature for distinguishing malignant from benign growths detected on screening CT scans
- Analysis and Strategy of Tools to Improve Remote Interactions and Document Management
- Investigation of potential mutagenicity of Molnupiravir in COVID-19 patients
- Building Capacity for Research on Cancer and Aging: The UMGCCC-Medicare Database
- Data-informed Models to Identify Optimal Opioid Use Disorder Treatment Trajectories
- Patient and Caregiver Diversity in FDA Patient Engagement Activities and CBER-regulated Therapeutics
- Assessment of Patient Tolerance for Risk with High Intensity Focused Ultrasound (HIFU) that Destroys Prostate Tissue
- Engineering quality control into biomanufacturing of extracellular vesicle-based products
- Evaluating the utility of negative controls in drug safety and effectiveness studies using real-world data
- Measurement of Metal Ions and HPHCs in Electronic Nicotine Delivery Systems (ENDS) and Their Physio-pathological Impact on Cells of the Oral Cavity and Upper Respiratory Tract
- Improving efficacy and safety of pathogen inactivation strategies for platelet transfusion
- Trace metals and their impact on protein quality, safety, and efficacy
- Evaluation of the REMS Programs for Psychiatric Medications
- Communicating about COVID-19 Testing to Underrepresented Populations (Spanish version)
- Clinical Use of Drugs Including Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities
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Yale University-Mayo Clinic
- Informatics driven real world analysis of SARS-CoV-2 serologic response and in vitro diagnostic accuracy
- Characterization and analysis of high incidence of potentially unsafe prescribing of some Extended-Release opioid analgesics using Natural Language Processing of Electronic Health Records clinical notes
- Quantifying the relationship between inappropriate prescribing of opioid-tolerant-only medications to patients without prior opioid tolerance and opioid-related harms
- Development of optical and digital microscopy hardware, software, and statistical methods to enable computational pathology in low resources
- Standardizing multi-model data for the diagnosis and prognosis of coccidioidomycosis as a model for establishing harmonized core data for additional infectious diseases
- Implementation of a stakeholder survey to facilitate enhanced pediatric medical device innovation
- Qualitative analysis of gender differences in heart failure Patient Reported Outcomes (PROs)
- 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
- Identifying, Selecting, and Utilizing Quantitative Bias Analysis Methods
- Evaluating mobile health tool use for capturing patient-centered outcome measures in heart failure patients
- Linking data sources to elucidate non-fatal and fatal opioid-related overdose epidemiology and the role of FDA-regulated products
- A Mixed Methods Research Design to Identify Factors Influencing Prescriber Decision-Making about Pain Management and Opioid Prescribing
- Trends in Opioid Use Among Patients with Cancer
- The impact of novel positron emission tomography (PET) imaging tracers on real-world outcomes for patients with prostate cancer
- Evaluate Application of Artificial Intelligence to Adaptive Enrichment Clinical Trials
- Understanding the use of existing real-world data for medical product evaluation
- Postmarket surveillance with a novel mHealth platform
- A positive deviance approach for representing women, older adults and patients identifying as racial and ethnic minorities in oncology research
- Longitudinal analysis & visualization of patient-reported physical function & symptom data
- Sex differences in immune profiles of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) before and after vaccination
- Characterizing use, safety and efficacy of brand-name and generic drugs used to treat hypothyroidism
- Characterizing safety and efficacy of brand-name and generic drugs used to treat hypothyroidism among patients who switch therapy formulation
- Real world short and intermediate-term safety outcomes following atrial fibrillation ablation
- Evaluate the application of machine learning algorithms to the management of postpartum hemorrhage (PPH)
- Improving the diagnosis and treatment of women with myocardial ischemia and no obstructive coronary artery disease (INOCA)
- Qualitative techniques to define meaningful within-patient change in symptoms of advanced cancer patients
- Bayesian adaptive trial designs for neoantigen based immunotherapy and borrowing strength across subpopulations within the trial and from external controls
- Quantifying physical function in cancer patients undergoing chemotherapy using clinician-reported, patient-reported, and wearable device data sources
- Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations
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