Diversity and inclusion in interventional studies remains an ongoing concern, as highlighted by recent regulatory guidance in the U.S. The application of epidemiological methods are paramount to addressing issues in diversity and inclusion in both interventional and non-interventional research. The webinar will consist of three major components. The first section of the webinar, presented by Claudia Cabrera, will focus on health equity in clinical trial planning. The critical role of epidemiology and real-world evidence will be presented, and there will be a discussion of methods considerations including the clinical trial diversity index. The second portion of the webinar, presented by Paula Strassle, will address potential biases in observational data in the health equity setting. Issues of selection bias, differential missingness, and adjustment strategy will be presented along with and some proposed solutions. The third component of the webinar, presented by Macarius Donneyong, will focus on methodological frameworks for guiding the planning and implementation of health equity research in pharmacoepidemiology through the use of real-world data sources. A review of frameworks and methods for assessing health equity in pharmacoepidemiology will be provided, along with a discussion of how to evaluate real world databases for the suitability of health equity research. The webinar will conclude with a discussion of gaps and future directions and audience Q&A.

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 2023 is presented to Dr. Neil Dhopeshwarkar and collaborators for their paper --- Combining Super Learner with high-dimensional propensity score to improve confounding adjustment: A real-world application in chronic lymphocytic leukemia. 

Super Learner (SL) was proposed to assist with high-dimensional propensity score (hdPS) covariate selection and was found to improve bias reduction and precision compared to hdPS alone in the simulated setting. This paper compared the performance of SL-hdPS with hdPS alone in the applied setting of a cohort study comparing bleeding rates between ibrutinib- and bendamustine-rituximab-treated individuals with chronic lymphocytic leukemia. The study findings provide support for the use of SL-hdPS in applied observational studies. 

In this webinar, Dr. Dhopeshwarkar will present study findings followed by comments by PDS regional editor for the Americas, Dr. Vincent Lo Re. The audience will not only have the opportunity to discuss the paper with Dr. Dhopeshwarkar but to also ask questions regarding the PDS editorial process with Dr. Lo Re.

MODERATORS: Jennifer Lund | Shanna Trenaman
Use of Cholinesterase Inhibitors and Non-Steroidal Anti-Inflammatory Drugs and the Risk of Peptic Ulcers: A Population-Based Self-Controlled Case Series Study 
Máté Szilcz | Jonas Wastesson | Amaia Calderón-Larrañaga | Daniel Prieto-Alhambra | Pierre-Olivier Blotiere | Géric Maura | Kristina Johnell (Sweden)
Association of Anticholinergic Burden and Risk of Pneumonia in Aged People
Avery Shuei He Yang | Xin-Yu Fan Jiang | Daniel Hsiang-Te Tsai | Edward Chia-Cheng Lai (Taiwan)
National Surveillance Using a Clinical Quality Indicator for Prolonged Antipsychotic Use Among Older Australians Living with Dementia Who Access Aged Care Services 
Janet Sluggett | Tracy Air | Maria Inacio | Catherine Lang | Stephanie Ward | Susannah Ahern | Xiaoping Lin | Kasey Wallis | Gillian Caughey (Australia)
Effect of Non-benzodiazepine Hypnotics on Motor Vehicle Crashes Among Older Adults: A Sequential Target Trial Emulation 
Andrew Zullo | Marzan Khan | Melissa Pfeiffer | Seth Margolis | Brian Ott | Allison Curry | Nina Joyce (United States)
Association Between Antihypertensive Medication Initiation and Risk of Fractures Among Older Adults in VA Long-Term Care Facilities 
Chintan Dave | Yongmei Li | Michelle Odden (United States)
Cumulative Sodium-Glucose Cotransporter 2 Inhibitor Exposure and Incident Dementia: A Population-Based Cohort Analysis 
Che-Yuan (Joey) Wu | Carina Iskander | Christa Wang | Lisa Xiong Baiju Shah | Jodi Edwards | Moira Kapral | Nathan Herrmann | Krista Lanctôt | Hugo Cogo-Moreira | Bradley MacIntosh | Jennifer Rabin | Sandra Black | Refik Saskin | Walter Swardfager (Canada)

Real-world evidence (RWE) studies that utilize existing healthcare data to evaluate treatment effects are subject to multiple sources of bias. While confounding and data quality are often considered the major challenges in RWE generation, it has been shown that many observational studies yield biased results because of self-inflicted and avoidable errors in study design. 

Learning Objectives:  

• Discuss major sources of avoidable bias in RWE studies of treatment effects. 
• Describe strategies that will help the audience identify such bias. 
• Discuss current approaches to avoiding self-inflicted bias when designing RWE studies.  

Target Audience: Any are welcome. 

Presenter: Katsiaryna Bykov, Brigham and Women’s Hospital and Harvard Medical School  

Moderator: Mugdha Gokhale, Pfizer 

The ISPE student council and RWE collaborative special interest group (SIG) are coming together with four pharmacoepi experts in academia, regulatory, and industry to discuss their careers. Listen to the journeys of successful professionals and bring your questions!

Learning Objective: Discuss different paths in RWE collaborative careers

Target Audience:  Any and all are welcome.

Presenters:

Shirley V. Wang, PhD – Associate Professor, Harvard Medical School

Wei Zhou, MD, PhD,  - Associate Vice President and Head of Oncology, Value, Evidence, and Outcomes (VEO), Eli Lilly and Co

Patrice Verpillat, MD, MPH, PhD – Head of the Real World Evidence (RWE) Workstream, European Medicines Agency (EMA)

Moderator:

Liz Mansi, ISPE student council chair

SISPE presents a webinar on CVs/Resumes and job applications featuring experts Daniela Moga (University of Kentucky) and Jenny Sun (Pfizer). Dr. Moga will discuss crafting effective CVs, teaching and research statements, and academia interview strategies. Dr. Sun will share valuable insights on industry applications, translating academic CVs into professional resumes, and excelling at industry interviews. The goal of this webinar is to enhance pharmacoepidemiology job application skills with practical advice from professionals in academia and industry.

The simultaneous rise in demand for global RWD and proliferation of potential data sources and analytic tools require pharmacoepidemiologists to understand and collaborate on data strategy. This four-part video series on data strategy, including governance, quality management, architecture, and asset planning was co-developed by ISPE members and Donna Burbank of Global Data Strategy.

The simultaneous rise in demand for global RWD and proliferation of potential data sources and analytic tools require pharmacoepidemiologists to understand and collaborate on data strategy. This four-part video series on data strategy, including governance, quality management, architecture, and asset planning was co-developed by ISPE members and Donna Burbank of Global Data Strategy.

Presented by 

Dr. Celine Chui (Hong Kong), Dr. Masao Iwagami (Japan), Prof Edward Lai (Taiwan), Dr. Judy Shin (South Korea)

This webinar aims to provide an in-depth understanding of the electronic health records (EHR) databases in Hong Kong, Japan, Taiwan, and South Korea. Participants will gain valuable insights into the unique features of each database, including Hong Kong's CDARS (Clinical Data Analysis and Reporting System), Japan's MDV (Hospital-based database provided by Medical Data Vision Co., Ltd) and JMDC (claims data provided by JMDC Inc.), South Korea's HIRA (Health Insurance Review and Assessment Service) and NHID (The National Health Information Database), and Taiwan's NHIRD (National Health Insurance Research Database) and CGRD (Chang Gung Research Database). Presenters from each region will introduce these databases and showcase research done using these databases.

Learning Objectives:

1. Provide an overview of electronic health record databases in Asia with potential for international collaboration.

2. Foster cross-continental international collaboration.

The simultaneous rise in demand for global RWD and proliferation of potential data sources and analytic tools require pharmacoepidemiologists to understand and collaborate on data strategy. This four-part video series on data strategy, including governance, quality management, architecture, and asset planning was co-developed by ISPE members and Donna Burbank of Global Data Strategy.