This year’s pharmacoepidemiology summer school includes diverse topics relevant to studying safety and effectiveness of interventions using epidemiological methods.
Format: Lectures, group work, and exercises.
Prerequisites: Basic training in epidemiology and biostatistics is assumed.
Equipment: Laptop. All participants will get a short-course STATA license, which needs to be installed on the laptop.
All day (9.00 am - 4.00 pm)
This course is designed to provide an overview of the design of clinical trials and will include early phase trials, feasibility/pilot studies, and phase 3 confirmatory trials. We will discuss concurrent vs historical controls, allocation to groups, blinding, choice of primary and secondary outcomes, controlled vs real world/pragmatic settings, hypothesis testing including multiple testing, and the calculation of target sample sizes for trials. The principles introduced will be illustrated with published studies, many from Janet’s own collaborative research. Participants will have the opportunity to engage in practical work in small groups, critiquing extracts from published trials, repeating published sample size calculations in Stata, and presenting conclusions to their peers. Foundational understanding of research methods and statistics will be assumed, but the emphasis will be on understanding principles and not on derivation of formulae.
Instructor
Janet Peacock, MSc, PhD
Department of Clinical Epidemiology, Aarhus University, Denmark
Department of Epidemiology, Geisel School of Medicine, Dartmouth College, USA
All day (9.00 am - 4.00 pm)
This course in intended to be an overview of the guidance, practices, and tools involved to ensure the safety of vaccines. It will cover safety surveillance throughout all stages of clinical development and post-authorization use. The characteristics of an ideal vaccine monitoring system will be reviewed, and the differences in systems that exist between countries, largely upon economic lines, will be described.
Weaknesses in the current infrastructure and challenges to the generation of robust evidence in real world data sources will also be explored. Finally, the exciting opportunities afforded by genomics, multi-omics and artificial intelligence to shift the paradigm in vaccine safety science will be introduced.
This course is designed to provide an overview of how the safety of vaccines are monitored through clinical development to implementation in immunization programs.
Topics/elements/study designs covered include AEFI surveillance, vaccine pharmacovigilance, and vaccine pharmacoepidemiology.
Participants will have an opportunity to learn about a topic that is much more complex and nuanced than most believe. No programming or use of software, this day will be more clinically based.
Prerequisites: curiosity, enthusiasm, and an open mind.
Instructor
Rebecca Chandler, MD, Senior Clinical Development Vaccine Safety Lead
Coalition for Epidemic Preparedness Innovations (CEPI), Uppsala, Sweden
All day (9.00 am - 4.00 pm)
Amongst many ways to account for confounding in observational studies, self-controlled methods have been gaining popularity over recent years. Designs such as the self-controlled case series and the case cross-over make comparisons within individuals, and remove the need to account for between person differences.
This course is designed to introduce the self-controlled case series and case cross-over designs to participants. We will explore both methods, their underlying assumptions, some examples of their application, and more recent methodological developments.
Participants will have an opportunity to gain practical experience in conducting analyses for both study designs and will gain experience in thinking through self-controlled design features in small group discussions. The analytical part of the course will involve the use of Stata and will form ~ a quarter of the course.
A small amount of pre-course reading material will be circulated to participants, and it is assumed that participants are already familiar with basic epidemiological study design (e.g. cohort and case control designs) and the statistics underpinning them.
Instructor
Ian Douglas, MSc, PhD
London School of Hygiene and Tropical Medicine, London, UK
All day (9.00 am - 4.00 pm)
The course will cover main methodological challenges of studying medication safety in pregnancy, offering solutions through design and analytic approaches. Topics will include manifestations of selection bias, confounding, and information bias in pregnant populations. We will discuss challenges interpreting results when these biases are present and explore ways to circumvent them. The course will combine lectures, small-group discussions, and a group project. Suggested pre-course reading includes 2-4 scientific articles.
Instructors
Irene Petersen, MSc, PhD
Department of Clinical Epidemiology, Aarhus University, Denmark
Research Department of Primary Care and Population Health, University College London, UK
Vera Ehrenstein, MPH, DSc
Department of Clinical Epidemiology, Aarhus University, Denmark
Morning (9.00 am - 12.00 noon)
Participants will explore the importance of AI literacy, understand stakeholder perspectives on the use of AI in pharmacoepidemiology, and delve into specific applications. Key topics covered include the academic and regulatory perspectives on AI, causal machine learning (with both theoretical and practical tutorials), and generative AI, illustrated through research examples. The course will involve programming and the use of the statistical software R. R programming experience is helpful but not mandatory. Pre-course preparation will include a brief reading list to familiarize participants with foundational concepts.
Instructor
Maurizio Sessa, MPharm, PhD
Department of Drug Design and Pharmacology, Pharmaceutical Informatics, University of Copenhagen, Denmark
