Center faculty have active research portfolios, ranging from analyses of opioid abuse and diversion to the safety of new orally available anticoagulants to the development of innovative comparative effectiveness research methods.
The majority of the Center’s research funding is provided through grants from the Agency for Healthcare Research and Quality, the National Institutes of Health and other governmental and nonprofit sources.
A select example of current or recently completed research projects is provided below.
Developing Personalized Immunosuppression for Older Kidney Transplant Recipients (McAdams DeMarco)
Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (R01DK120518)
Kidney transplantation (KT) is a growing treatment option for the >400,000 older adults (age ≥55) in the U.S. who suffer from end-stage renal disease (ESRD) and this population will rely on lifelong immunosuppression. The aim of this study is to quantify the differential effects of immunosuppression on cost-effectiveness, efficacy, morbidity, and mortality for older KT recipients and use this information to develop a risk calculator to help guide the choice of immunosuppression in older KT recipients.
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) Study (Segal)
Funding Source: National Institute on Aging (Desai-PI, Harvard)
This study seeks to evaluate the potential effectiveness of existing drugs for the prevention of Alzheimer’s disease using real-world data from multiple sources.
Biologics Effectiveness and Safety (BEST) Initiative: Development of New and Innovative Methods for Automated Reporting for CBER-Regulated Biological Products (Segal)
Funding Source: FDA (IBM Investigators- PI)
This project is working on developing automated methods for evaluating CBER-regulated products such as blood components and products derived from blood using data from the electronic health records.
The PRIORITIZE Study: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders (Segal)
Funding: Patient Centered Outcomes Research Institute Nelson (PI, University of Florida)
This is a large, pragmatic trial comparing new drugs for treatment of hepatitis C. Dr. Segal and colleagues at Hopkins are applying new methods to translate the trial results to populations who were not enrolled in the trial.
Utilization Management in the Medicare Part D Program (Alexander)
Funding Source: National Institute on Aging
Utilization management is becoming increasingly common in the Medicare Part D program, yet despite the evidence from the Medicaid program that utilization management can have adverse health and other consequences, relatively little is known about the effects of utilization management on most Medicare Part D beneficiaries. This study will begin to explore the effects of utilization management on beneficiaries’ health outcomes for common conditions such as community acquired pneumonia and urinary track infections.
Effect of Drug Coupons on Drug Utilization and Expenditures (Anderson)
Funding Source: John and Laura Arnold Foundation
In the private sector, drug manufacturers help patients access drugs by offering coupons, yet coupons also lead to higher overall drug spending. We are comprehensively evaluating the effect of coupons as well as assessing policies that counteract the adverse consequences of coupon use, including restricting their use; reforming policies regarding how coupons are incorporated into cost-sharing; and requiring coupon programs to apply to all drugs rather than branded drugs alone.
Medication Use and Adverse Events in CKD (Grams)
Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases
Adverse drug events account for approximately 250,000 deaths each year in the U.S. People with chronic kidney disease (CKD), a common condition afflicting >10% of the world population, are at particularly high risk. The proposed research will use electronic health record data from 5 million people in 5 cohorts to provide evidence regarding the risks of specific medications across the range of kidney function, thus informing the development and implementation of individualized prevention strategies to improve drug safety.
Comparative Effectiveness of Direct Oral Anticoagulants versus Warfarin in Cancer Survivors with Atrial Fibrillation (Mehta)
Funding Source: The BMS/Pfizer American Thrombosis Investigator Initiated Research Program (ARISTA-USA)
The project aims to evaluate the safety and effectiveness of direct oral anticoagulants versus warfarin in cancer survivors with non-valvular atrial fibrillation. The evidence obtained from this real-world study will aid clinical decision making to manage non-valvular atrial fibrillation in cancer patients.
Patterns, Variation and Outcomes of Direct Oral Anticoagulants in Long-term Care Nursing Home Residents with Atrial Fibrillation (Mehta)
Funding Source: The BMS/Pfizer American Thrombosis Investigator Initiated Research Program (ARISTA-USA)
The study aims to describe patterns of direct oral anticoagulants use, compare safety and effectiveness of direct oral anticoagulants to warfarin and determine healthcare use and costs associated with direct oral anticoagulants use in nursing home residents with non-valvular atrial fibrillation. The project will provide useful information to improve oral anticoagulant use in in nursing home residents.
Examining Sickle Cell Acute Pain in the Emergency vs. Day Hospital (ESCAPED) (Segal*)Funding Source: Patient-Centered Outcomes Research Institute
Dr. Jodi Segal is collaborating with her colleague Dr. Sophie Lanzkron who is funded by the Patient Centered Outcomes Research Institute to learn which is the better site of care for adults with sickle cell anemia – the infusion clinic or the emergency department. The primary goal of this study is to understand where patients can most quickly access medications for pain relief.
Drug Pricing (Anderson)Funding Source: John and Laura Arnold Foundation
Researchers have proposed a wide range of policy options that attempt to balance the desire to lower pharmaceutical spending, provide access to essential drugs, and foster drug innovation. The problem is that many of them, while good ideas, have little chance of actually being adopted. We are using empiric methods to develop viable policy options and using established relationships with policy makers to facilitate their implementation when the opportunity arises.
Competitive Renewal for Multicenter Uveitis Steroid Treatment (MUST) Trial (Holbrook)Funding Source: National Eye Institute
The goal of this research is to develop a clinical trials network capable of engaging in several clinical trials of the treatments of uveitis and its complications. Three clinical research studies are to be pursued, including continued follow-up of the MUST trial participants, comparison of the relative effectiveness of adalimumab for severe uveitis and comparison of periocular versus intravitreal corticosteroids for the treatment of macular edema in patients with uveitis.
Center of Excellence in Regulatory Science and Innovation (Alexander)Funding Source: Food and Drug Administration
The primary charge of the FDA is to safeguard the health and well-being of the public through the application of scientifically sound regulatory activities. Partnerships with academic institutions provide these institutions a valued opportunity to work directly with regulators to fulfill the FDA’s mission while simultaneously providing the Agency opportunities for access and exposure to advanced scientific exchange and training as well as specific intellectual expertise and human capital focused on the FDA’s priority areas. The Johns Hopkins – FDA Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI) will ensure the FDA remains a standard-bearer in regulatory science.
Creating and Validating a Claims-based Indicator of Frailty (Segal)Funding Source: National Institute of Aging
This project will identify individuals with frailty using only administrative claims data. Frailty identified with administrative data may be used as an exposure variable to understand health outcomes of individuals with frailty, outcome variable for evaluating impact of interventions designed to prevent or delay frailty or effect modifier in models of treatment effectiveness.
Developing Structural Nested Models to Assess Safety and Effectiveness of Generic Drugs (Varadhan)Funding Source: Food and Drug Administration
Some clinicians and patients are reluctant to use generic medications due to fears of lesser effectiveness or concerns about toxicities or side effects. This project aims to enhance the FDA’s ability to evaluate the safety and effectiveness of generic drugs relative to their branded counterparts using healthcare utilization database (claims data), and electronic medical records (EMR).
Effect of Therapeutic Class on Generic Drug Substitutions (Segal)Funding Source: Food and Drug Administration
The use of generic drugs in place of branded drug products results in lower prices to insurers and patients. This project aims to advance knowledge about usage of generic drugs, substitution of generic drugs for brand-name drugs, and the modifiers of generic drug use at the patient, prescriber, and health system level.
Estimating Prevalence of Iron-Deficiency Anemia and Its Treatment Among Inflammatory Bowel Disease Patients in the United States, 2010-2013 (Hutfless)Funding Source: Luitpold Pharmaceuticals
Anemia is a common complication of inflammatory bowel disease, however there are no American guidelines for its screening and treatment. This project aims to provide data that can be used by the American Gastroenterology Association, Crohn’s & Colitis Foundation of America or other groups to provide the foundation for such guidelines.
Filling Two Major Gaps In The Analysis of Heterogeneity of Treatment Effects for Patient-Centered Outcomes Research (Varadhan)Funding Source: Patient-Centered Outcomes Research Institute (PCORI)
This project’s purpose is to find a better approach to understanding whether the same treatment effects people differently, known as heterogeneity of treatment effects. This study will in turn help people make better healthcare decisions by understanding whether differences in treatment effects are occurring. Research is focused on looking at the Bayesian approach, which uses information and beliefs from different stakeholders on treatment effect varying per person.
Impact of "Pill Mill" Laws (Alexander)Funding Source: Centers for Disease Control and Prevention
This project aims to generate objective data regarding the impact of Florida’s and other states’ “pill mill” laws on the epidemiology of prescription drug abuse. The project will be useful to multiple stakeholders involved in the review and reform of such policies and to others vested in reducing the public health costs of escalating prescription drug abuse.
Making Better Use of Randomized Trials: Assessing Applicablity and Transporting Causal Effects (Stuart*)Funding Source: Patient-Centered Outcomes Research Institute (PCORI)
Use of randomized clinical trials (RCTs) to inform clinical and policy decisions—even when trials are impeccably designed and conducted—requires the application of trial results to patients who differ from trial participants in significant ways. This research aims to develop and evaluate methods for assessing the applicability of RCT results and transporting trial results to broader target populations.
Patient-Oriented Research in Transplant and Oncology (Marr)Funding Source: National Institute of Allergy and Infectious Disease
The award supports the development of an infrastructure for epidemiologic research in Transplant and Oncology Infectious Diseases, including: (1) the development of a prospectively maintained dynamic cohort study, and (2) the linkage of elements from transplant and oncology databases, infection control records and electronic medical records. These resources will support research, including innovative work defining the epidemiology and outcomes of Clostridium difficile infection in oncology patients, as well as characterizing infectious complications in high-risk recipients of solid organ transplants.
Sensitivity Analysis Tools For Clinical Trials With Missing Data (Scharfstein)Funding Source: Patient-Centered Outcomes Research Institute (PCORI)
This project aims to create tools to address missing outcome data in clinical trials that can lead to unverifiable assumptions about treatment effect. The project will address this problem by creating a free methods and software package to access a global sensitivity analysis of clinical trials with missing data.
Towards Understanding the Patient Experience of Overuse of Medical Resource (Segal)Funding Source: National Institute of Aging
While overuse is pervasive throughout the healthcare system, older Americans may be particularly at risk for receipt of services where the potential for harm exceeds the potential for benefit. This award aims to to work towards harm reduction for older patients through parsimonious healthcare use.
Treatment Patterns and Barriers in Comorbid Mental and Substance Disorders (Mojtabai)Funding Source: National Institute of Drug Abuse
The majority of individuals with comorbid mental and substance disorders do not seek treatment and among those who do seek treatment, the outcomes of treatment are often worse than for those without comorbid disorders. This research uses data from two large US epidemiological surveys to compare the processes, clinical and social outcomes of treatment seeking among individuals with comorbid mental and substance disorders with those of individuals with mental disorders alone.
When is a Medicine Good Enough? The Problem of Therapeutic Equivalence, 1959-2009 (Greene)Funding Source: National Library of Medicine
Federal funding has helped to propel a movement to achieve higher-quality, lower-cost healthcare through comparative effectiveness research. Understanding the historical challenges entailed in building programs to encourage prescribers and consumers to favor the use of effective, safe, and inexpensive therapeutic equivalents will help stakeholders make more effective decisions in pharmaceutical utilization. This work will be of great relevance to audiences including policymakers, clinicians, historians and the lay public.