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
- 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
- More Information..
UCSF-Stanford University
- 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
- Improving adverse event detection related to biologic immunosuppressant use – a pilot study of the BERT deep learning model adapted to real-world clinical notes
- 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)
- More information..
University of Maryland
- 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
- More Information..
Yale University-Mayo Clinic
- 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
- More Information..