Methods and Applications of Synthetic Data in Pharmacoepidemiology (November 15, 2023)

Synthetic data is a form of model generated data that shares the same patterns and characteristics as real data. The applications of synthetic data in pharmacoepidemiology are still emerging, but can offer new ways for us to:

1. Enable the internal reuse of datasets and sharing data with external parties in a privacy-preserving manner (i.e., it can be seen as anonymization 2.0)

2. Augment and expand datasets that are small for training machine learning models

3. Mitigate bias in datasets by simulating observations from the under-represented groups

4. Simulate patients for clinical trials that are experiencing problems, including under-recruitment

Synthetic data can be created when a generative AI model is trained on source data, such as claims database or an EMR database. This AI-generated data would not have a one-to-one mapping to the original data, and therefore will have strong privacy preserving characteristics, and the generated data can be much larger than the original data. Some of these use cases have already been applied in practice and some are still in the formative stage of development. This webinar will give an overview of synthetic data generation and walk through some of the above applications.
This webinar is sponsored by the Digital Epidemiology Special Interest Group.

This webinar is aimed towards industry/service providers, academia, government/regulatory and students.

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Designing and Conducting Pragmatic Randomized Trials in Electronic Databases in ‎Pharmacoepidemiology (October 12, 2023)

This webinar covers key concepts in designing and conducting pragmatic randomized trials in electronic databases, like electronic health record systems and administrative claims databases. These designs are often referred to as "database-randomized trials", which may be increasingly possible within electronic databases used in pharmacoepidemiology. Content will include conceptual differences from traditional pragmatic trials, advantages and disadvantages of these types of trials, and relevant examples.

This webinar is aimed towards industry/service providers, academia and students.

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Pharmacoepidemiology and Drug Safety Best Paper of 2022 --- Novel Methods for Pregnancy Drug Safety Surveillance in the FDA Sentinel System (September 15, 2023)

Pharmacoepidemiology and Drug Safety (PDS), the official journal of ISPE, presents the Ronald D. Mann Best Paper Award each year to the strongest contribution within a given volume of the journal. The award for 2022 is presented to Dr. Elizabeth A. Suarez and collaborators for their paper ”Novel Methods for Pregnancy Drug Safety Surveillance in the FDA Sentinel System.”

The paper discussed the application of TreeScan™, a statistical data mining tool, within the FDA Sentinel System to simultaneously identify multiple potential adverse neonatal and infant outcomes after maternal medication exposure. This method could supplement existing approaches to enhance the surveillance of medication safety during pregnancy.

In this webinar, Dr. Suarez will present findings of their study, followed by comments by PDS regional editor for the Americas, Dr. Vincent Lo Re. Audience will not only have the opportunity to discuss the paper with Dr. Suarez and but also ask questions regarding manuscript submission to PDS with Dr. Lo Re.

This webinar is aimed towards industry/service providers, academia, government/regulatory, and students.
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Methodological Considerations for Designing Pharmacoepidemiology Studies in the COVID-19 Era  (June 23, 2023)

The global COVID-19 pandemic has generated enormous morbidity and mortality, as well as large health system disruptions including changes in use of prescription medications, outpatient encounters, emergency department admissions, and hospitalizations. These pandemic-related disruptions are reflected in real-world data derived from electronic medical records, administrative claims, disease or medication registries, and mobile devices. This webinar will discuss how pandemic-related disruptions in healthcare utilization may impact the conduct of noninterventional studies designed to characterize the utilization and estimate the effects of medical interventions on health-related outcomes, including possible threats to external validity (participant selection) and internal validity (for example, confounding, selection bias, missing data bias).

This webinar is aimed towards students, trainees, young professionals, anyone interested in methodology and pharmacoepidemiologic research.

Join career lead Liz Mansi from the Student Council for a discussion of pharmacoepidemiology careers with regulatory and academia leaders. June 2023

ISPE Webinar Series - Methodological Challenges for Pharmacoepidemiologic Studies of Geriatric ‎Cancer Care (May 25, 2023)

This webinar will cover the concepts and challenges of geriatric ‎pharmacoepidemiology research, different study designs and examples of their ‎application. Participants will learn about the unique characteristics of the ‎ageing population, ethical considerations, and study design choices. The ‎webinar will present examples of studies investigating medication safety, ‎polypharmacy, medication adherence and current market trends. Participants ‎will gain practical insights into developing successful geriatric ‎pharmacoepidemiology studies and effective marketing strategies for the ‎ageing population.‎ 

This webinar is aimed towards students, trainees, young professionals, anyone interested in methodology and pharmacoepidemiologic research.

Measures of Drug Utilization Based on Individual-Level Drug Dispensing Data (May 16, 2023)

Drug utilization studies are essential to facilitate rational drug use in the society. This webinar will provide an overview of drug utilization measures that can be used with individual-level drug dispensing data. Six topics will be reviewed: (1) basic measures of drug utilization which are used to describe changes in drug use over time or compare drug use in different populations; (2) treatment adherence measures with specific focus on persistence and implementation; (3) how to measure drug combinations which is useful when assessing drug-drug interactions, concomitant treatment, and polypharmacy; (4) prescribing quality indicators and measures to assess variations in drug use which are useful tools to assess appropriate use of drugs; (5) proxies of prescription drug misuse and skewness in drug use; and (6) considerations when describing the characteristics of drug users or prescribers.

This webinar is aimed towards students, trainees, young professionals, anyone interested in methodology and pharmacoepidemiologic research.

Listen in as SISPE Council member Liz Mansi moderates a discussion on pharmacoepidemiology careers with four industry leaders. March 2023

Pharmacoepidemiology and Pharmacoeconomics are much closely related fields in terms of research and application of real-world data. Therefore, moving toward collaboration and networking would be advantageous for students from both parties in terms of learning and understanding how to use pharmacoepidemiologic data to pharmacoeconomic assessments as well as how to employ pharmacoeconomic evaluations in real-world evidence and practice.

This webinar is aimed towards students, trainees, young professionals and researchers interested in pharmacoepidemiology & pharmacoeconomics research.

Objectives
1. To increase the understanding of how pharmacoepidemiology data can be used in pharmacoeconomic evaluations
2. To understand how pharmacoeconomic evaluations can be used or incorporated into pharmacoepidemiology studies and real-world evidences
3. To make an aware on how pharmacoepidemiology and pharmacoeconomics can make its best use among those researchers involved in both areas or interested parties

ISPE Webinar Series - Overview of negative control approaches and its use as empirical calibration for confidence intervals and p-value (January 17, 2023)

This webinar will discuss negative control approaches in pharmacoepidemiologic research. The speaker will introduce the basic concept and discuss key challenges & potential solutions of negative control approach in pharmacoepidemiologic studies. The content will cover the overview of negative control approach, selection of an appropriate negative control, using negative control to calibrate confidence intervals and p-values, accounting for the random and systematic error, examples of applying negative control approach.

This webinar is aimed towards students, trainees, young professionals, anyone interested in methodology and pharmacoepidemiologic research.