Pharmacoepidemiology Research

 

Epidemiologists working in the area of pharmacoepidemiology apply epidemiologic reasoning, methods, and knowledge to the study of the uses and effects, beneficial and harmful, of prescription and over the counter drugs, biologics, vaccines, and medical devices in human populations.Traditionally, pharmacoepidemiology was primarily concerned with post-marketing studies of drug safety. Over the past 15 years, it has evolved toward a broader focus on epidemiologic questions arising in drug and vaccine development and in health services research more generally, including the observational study of beneficial or intended effects. Studies of intended drug effects are also known as effectiveness studies and include comparative effectiveness research (CER) studies.

Pharmacoepidemiology research is often based on large health care utilization databases using nonexperimental study of intended and unintended drug effects outside of randomized controlled trials. The scope of pharmacoepidemiology is broad, encompassing such diverse areas as:

  • Confounding by indication or disease severity
  • Validation of outcomes in large administrative databases
  • Methods to reduce bias resulting from healthy initiator, healthy adherer, and healthy user effects
  • Adverse events and vaccine research
  • Methods such as propensity score analysis, instrumental variable analysis, and doubly robust estimation
  • Medical devices
  • Identification of heterogeneity in treatment effects
  • Pharmacogenetics
  • Development and use of patient reported outcomes
  • Sytematic review and meta-analysis

 

The Center for Pharmacoepidemiology is a unique partnership between the UNC Gillings School of Global Public Health and all entities developing, producing, marketing, delivering, or regulating drugs, biologics, vaccines, or medical devices. See CPE.
 
Students in the Pharmacoepidemiology Program receive training in how to conduct high-quality epidemiologic research that directly addresses both substantive and methodologic questions. Students gain experience through interdisciplinary opportunities in courses and collaborative work with researchers from the Schools of Public Health, Medicine, and Pharmacy, as well as through graduate research assistant opportunities with researchers and faculty in the Department of Epidemiology and epidemiology researchers working with GSK, Merck and other industry partners. Through fellowships and internships, students learn how to engage with industry and government stakeholders and become exposed to applied epidemiological research by and for industry partners, federal stakeholders, and international health organizations.Program faculty (Department of Epidemiology)

Til Stürmer
Program Leader

M Alan Brookhart
Deputy Program Leader

Michele Jonsson-Funk
Jenny Lund
Charles L. Poole
Alice White

Collaborating faculty (UNC)

Christy Avery (Department of Epidemiology)
Tim Carey (Sheps Center for Health Services Research)
Bill Carpenter (Health Policy and Management)
Steve Cole (Department of Epidemiology)
Alan Ellis (Sheps Center for Health Services Research)
Gang Fang (Eshelman School of Pharmacy)
Joel Farley (Eshelman School of Pharmacy)
Steve Marshall (Department of Epidemiology)
Steve Meshnick (Department of Epidemiology)
William C. Miller (Department of Epidemiology)
Kari E. North (Department of Epidemiology)
Betsy Sleath (Eshelman School of Pharmacy)
Jennifer Smith (Department of Epidemiology)
Annelies Van Rie (Department of Epidemiology)
Eric Whitsel (Department of Epidemiology)Pharmacoepidemiology Training at UNC

There are 3 courses specifically for those interested in the pharmacoepidemiology program.
Introduction to Pharmacoepidemiology (EPID 765) is the foundation course for pharmacoepidemiology students. It is taught every other year (odd years, i.e., again in 2013) in the spring semester. These 2 courses should be taken together either in the first or second year depending on the year students enter the program. They cover the basics of pharmacoepidemiologic research including one of its main aspects, the use of large automated databases.
Epidemiologic Research with Health Care Databases (EPID 690.XXX), is taught in parallel to EPID 765 in the spring semester every other year (odd years, i.e., again in 2013).
Advanced Pharmacoepidemiogic Methods (EPID 690.XXX) will be taught in the spring semester every other year (even years) starting in 2012. This course should be taken either in the second or third year. The course will cover state-of-the art pharmacoepidemiologic and nonexperimental comparative effectiveness research methods both in theory and in practice (implementation). The introductory pharmacoepidemiology course (EPID 765, see above) is a prerequisite for this course.
These courses supplement the Department’s core methodology course sequence by enhancing the student’s ability to apply epidemiological methods and reasoning to practical problems of pharmacoepidemiology. Numerous other courses from the School of Public Health and other related UNC departments are available, including health economics, clinical trial design, survey and questionnaire development, and medical geography.
 
To complement students’ academic skills, faculty advisors in the program work with students to identify internship opportunities for gaining first-hand experience in pharmacoepidemiology practice within federal and international agencies, pharmaceutical companies and research organizations.
 
In addition to the coursework available, pharmacoepidemiology faculty and students meet twice monthly to discuss recent pharmacoepidemiology methods and share current research projects. UNC also has an active student chapter of the International Society for Pharmacoepidemiology (ISPE) and helps to coordinate the annual Harry Guess Memorial Lecture in Pharmacoepidemiology.
 
 
Program faculty (Department of Epidemiology)

Til Stürmer
Program Leader

M Alan Brookhart
Deputy Program Leader

Michele Jonsson-Funk
Jenny Lund
Charles L. Poole
Alice White

Collaborating faculty (UNC)

Christy Avery (Department of Epidemiology)
Tim Carey (Sheps Center for Health Services Research)
Bill Carpenter (Health Policy and Management)
Steve Cole (Department of Epidemiology)
Alan Ellis (Sheps Center for Health Services Research)
Gang Fang (Eshelman School of Pharmacy)
Joel Farley (Eshelman School of Pharmacy)
Steve Marshall (Department of Epidemiology)
Steve Meshnick (Department of Epidemiology)
William C. Miller (Department of Epidemiology)
Kari E. North (Department of Epidemiology)
Betsy Sleath (Eshelman School of Pharmacy)
Jennifer Smith (Department of Epidemiology)
Annelies Van Rie (Department of Epidemiology)
Eric Whitsel (Department of Epidemiology)
Pharmacoepidemiology is the application of the epidemiologic knowledge, methodology, and reasoning to the study of the use and the beneficial and harmful effects of drugs (biologics, medical devices) in human populations. Pharmacoepidemiology covers both the descriptive epidemiology (use) and the analytic epidemiology (effects on outcomes). Largely defined by the exposure (drugs), pharmacoepidemiology overlaps with many substantive areas of epidemiology mainly defined by disease-outcomes (e.g., cardiovascular, cancer, infectious diseases, reproductive). The Pharmacoepidemiology Program provides students with training to conduct high-quality epidemiologic research that directly addresses both methodologic and substantive questions in the study of drugs in populations.

Learning Objectives

Pharmacoepidemiology students with training at the doctoral level will have:

  1. Broad strength in epidemiologic and statistical methods.
  2. Knowledge about the unique research challenges and opportunities related to medical interventions.
  3. Knowledge about the unique research challenges and opportunities related to specific automated databases.
  4. Core competencies in the design, analysis, and interpretation of pharmacoepidemiologic and nonexperimental Comparative Effectiveness Research (CER) studies.
  5. Facility with current concepts of biases and current methods to reduce/limit these in pharmacoepidemiologic studies.
  6. Experience with practical application of their research skills in multidisciplinary teams, including the implementation and dissemination of pharmacoepidemiologic research

Courses:

Introduction to Pharmacoepidemiology (EPID 765) is the foundation course for pharmacoepidemiology students. It is taught by Til Stürmer and Alan Brookhart every other year (odd years) in the spring semester and has an introductory epidemiology and biostatistics course as prerequisites (EPID 600 and BIOS 600 or equivalents). This course provides an introduction to the application of epidemiological methods and reasoning to the study of the effects of drugs in populations. Main topics include: methodologic issues in observational studies of drugs and vaccines, the use of epidemiology for safety monitoring and risk management, adherence issues in pharmacoepidemiology studies, and information resources for pharmacoepidemiology studies. This course uses the Textbook of Pharmacoepidemiology (Strom and Kimmel, 2007) as a resource.

Epidemiologic Research with Healthcare Databases (EPID 690.005) is the second core course within the pharmacoepidemiology program. It is taught by Alan Brookhart and Til Stürmer in parallel to EPID 765 in the spring semester every other year (odd years). The course will provide the students with the tools necessary to design epidemiologic studies within automated databases.

Advanced Pharmacoepidemiogic Methods (EPID 690.XXX) will be taught jointly by Alan Brookhart and Til Stürmer in the spring semester every other year (even years) starting in spring 2012. Prerequisites are the full epidemiology methods sequence, including, potentially in parallel, Analysis of Longitudinal Data usually taken by students in the 4th semester (spring semester) and the introductory pharmacoepidemiology course (EPID 765, see above). This course will cover state-of-the art pharmacoepidemiologic and nonexperimental Comparative Effectiveness Research methods both in theory and in practice (implementation).

In addition to the coursework available, pharmacoepidemiology faculty and students meet every week in the pharmacoepidemiology seminar (EPID 893) to discuss recent pharmacoepidemiology methods and share current research projects. UNC also has an active student chapter of the International Society for Pharmacoepidemiology (ISPE) and helps to coordinate the annual Harry Guess Memorial Lecture in Pharmacoepidemiology.

To complement students’ academic skills, faculty advisors in the program work with students to identify internship opportunities for gaining first-hand experience in pharmacoepidemiology practice within federal and international agencies, pharmaceutical companies and research organizations. Common funding sources for pharmacoepidemiology students include graduate research assistantships with Department of Epidemiology faculty and industry partners (GSK, Merck), and fellowships available through the Center for Pharmacoepidemiology. Additionally, since student interests often span between pharmacoepidemiology and another substantive area, training grants within other epidemiology areas also support pharmacoepidemiology students.