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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.

Johns Hopkins Drug Consulting Service

Who We Are

The Center for Drug Safety and Effectiveness Consulting Service is a group of clinical and scientific experts at Johns Hopkins University who provide consultative services regarding prescription drug safety, effectiveness and utilization to the life sciences industry.  The Service is structured around the core faculty of the Center for Drug Safety and Effectiveness who reflect the remarkable breadth and depth of expertise with Johns Hopkins Medicine and the Bloomberg School of Public Health.

What We Do

The Center’s consulting services are oriented around the needs of its clients - including pharmaceutical manufacturers, biotechnology companies, and insurers – and are broadly organized into four areas: pharmacoepidemiology and outcomes research; regulatory affairs and risk/benefit appraisal; study design and analytics; and pharmacoeconomics.  These services are used by clients for a number of purposes, ranging from the fulfillment of regulatory requirements to guiding strategic decision-making regarding research and development to extracting greater value from health care expenditures.  The Center also has additional expertise and capabilities, including partnerships with clinicians from Johns Hopkins Medicine, as well as the ability to provide extensive training of scientists at all stages of career and professional development and at varying levels of intensity.  We are equipped to provide a variety of levels of service depending upon specific clients’ needs, ranging from expert consultation regarding specific aspects of a study design to the design, implementation and analysis of complex Phase IV observational studies. 

Core Capabilities

Pharmacoepidemiology and Outcomes Research
Comparative effectiveness research with observational data; advanced methods for quantifying uptake and determinants of drug utilization; pharmacovigilance and safety assessments

Regulatory Affairs and Risk/Benefit Appraisal
Advanced methods for assessing and balancing benefit and risk; evidence synthesis including bayesian, meta-analytic, network meta-analytic and systematic review techniques; assessment of patient and clinician preferences; expertise in global marketplace and international pharmaceutical policy

Study Design and Analytics
Design of sophisticated comparative effectiveness, pharmacovigilence and drug utilization research

Cost-benefit analysis; cost-effectiveness analysis

Additional Expertise and Capabilities

Sophisticated services available through partnership with the Johns Hopkins Biostatistical Center, reflecting advanced expertise in causal inference, management of missing data, and other areas of statistical analyses

Clinical Expertise
Deep content knowledge based on scientists with active clinical practice in a variety of areas, including hematology-oncology, immunology, endocrinology, psychiatry, infectious disease and general medicine

Coursework for degree and non-degree candidates; conference and workshop development; certificate program in pharmacoepidemiology and drug safety; seminar series; onsite symposia and mini-courses

How We Do It

We encourage interested parties to set up an informational session with one of our Center directors, G. Caleb Alexander, MD, MS ( or Jodi Segal, MD, MPH (  These sessions can take place in-person or by phone and will explore the clients’ needs and our resources to meet those needs.  From there, a contract will be prepared for the clients’ review describing the services, deliverables, timeline and payment structure.

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