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Clinical Decision Making
Clinical Decision Making
Prescription drugs are prescribed during clinical encounters. Thorough and effective patient-provider communication about the benefits, risks, costs and alternatives to prescription medicines is a vital part of clinical care. The Center supports research and advocacy to identify and overcome barriers to patient-provider communication to improve safe medication use and to maximize adherence.
Comparative Effectiveness
Comparative Effectiveness
For stakeholders to make informed decisions about prescription drug use, they need timely evidence about the comparative effectiveness of therapies and their alternatives, including their risks and benefits. Incomplete evidence contributes to overuse of some therapies, underuse of others and risky prescribing. The Center supports innovative research into these topics.
Global Medicines
Global Medicines
Ensuring adequate access and affordability of prescription medicines poses major and unique challenges for countries around the world. These challenges are particularly salient in emerging economies that account for an increasing proportion of the world's population and pharmaceutical expenditures. Center investigators focus on how public policy can be optimized to maximize global drug availability and access.
Medication Safety
Medication Safety
Some adverse effects of medicines only come to light after medications have been on the market and widely used. Center investigators are working to develop new methods for identifying risk, to predict the likelihood of high-risk medicines or drug combinations and to protect the public from excessive exposure to these products.
Policy Analyses
Policy Analyses
Complex and dynamic policies govern prescription drug regulation. Policymakers face the challenge of maximizing innovation while protecting public health, and developing payment policies that promote evidence-based usage. Center investigators evaluate regulatory policies to provide policymakers with information to continually optimize pharmaceutical regulation.
Prescription Abuse
Prescription Abuse
Prescription drugs provide therapeutic value to millions of Americans. At the same time, rates of prescription drug abuse and overdose deaths are skyrocketing. The annual number of fatal drug overdoses in the United States now surpasses those of motor vehicle deaths. The Center supports innovative research and public advocacy to help stem this epidemic.

Funded Research

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 research projects is provided below.

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.

Integrating Multiple Data Sources For Meta-Analysis To Improve Patient-Centered Care And Research (Dickersin)

Funding Source: Patient-Centered Outcomes Research Institute (PCORI)
This project focuses on creating better access to existing research to see how well treatments work. The project will explore whether including information from many data sources for two high-impact case studies will improve reliability and validity in research. They will also create open-access guidance which can be added to by others on using multiple data sources as well as examine whether patient-centered outcomes (PCO) data have been included in clinical trial datasets that can be used for future PCO research.

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. 
*Co-investigator

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.

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