ICPE Pre-Conference Course

Let’s git it started

Janick Weberpals, RPh, PhD
jweberpals.academic@gmail.com

August 23, 2025

Welcome to ICPE 2025

Meet Your Faculty

Janick Weberpals,
RPh, PhD Associate Director, Oncology Data Science & AI, AstraZeneca

Shirley Wang,
PhD Associate Professor, Brigham & Women’s Hospital, Harvard Medical School

Anna Schultz
PhD, MSc Assistant Professor, London School for Hygiene and Tropical Medicine

John Tazare,
PhD Assistant Professor, London School for Hygiene and Tropical Medicine

Disclosures

Disclosure

  • JW is an employee at AstraZeneca and own shares in AstraZeneca. The views and opinions expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of AstraZeneca. The author is presenting in a personal capacity.
  • SVW has been an ad hoc consultant to Cytel Inc, MITRE a federally funded research and development center for the Centers for Medicare and Medicaid Services, and the ACI Group for unrelated work.
  • AS is employed by LSHTM on a research grant funded by GSK.
  • JT has no disclosures.

Introduction to the topic

Transparency and reproducibility standards across the RWE lifecycle

Study conceptualization and pre-specification using HARPER1

Figure 1: HARPER protocol template

Study implementation
guidelines, training and engagement are lacking in non-interventional healthcare research community

Figure 2: Study implementation resources are still lacking (illustration generated by GPT).

Study reporting
guidelines like RECORD(-PE)2 and STROBE3

Figure 3: RECORD(-PE) study reporting
Figure 4: STROBE study reporting

Our agenda today

Table 1: Course timetable.

Course materials

You can find all course materials, setup instructions and further useful resources at:

https://janickweberpals.github.io/icpe-git-2025/

Figure 5: Landing page of ICPE 2025 course website.

PDS Special Issue

Figure 6: PDS Special Issue on Transparency and Reproducibility in Pharmacoepidemiology4

Technical Setup

Figure 7: Link to course website section with step-by-step instructions on technical setup for this course.

Important: Course evaluation

Figure 8: Instructions to complete the course eveluation in the conference app.

Course focus

What this course is about

  • Giving recommendations on how to enhance transparency and reproducibility across different stages of a RWE study implementation
  • What to consider when pre-specifying your study design and analyses
  • Version control of analytic code and computational reproducibility
  • Making your study report more transparent to others & future you

What this course is NOT about

  • Any specific programming language
  • Statistical programming language bootcamp
  • Any specific study design or statistical analysis considerations

Why is this important?

Increasing expectations and policies from various stakeholders regarding the provenance, sharing and audit trial of study documents including analytic code

  • Regulatory

“Sponsors should ensure that RWD and associated programming codes and algorithms submitted to FDA are documented, well-annotated, and complete, which would allow FDA to replicate the study analysis using the same dataset and analytic approach” (FDA5)

  • Publishing

“We will make code sharing mandatory too.” (BMJ6)

References

1.
Wang SV, Pottegård A, Crown W, et al. HARmonized protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force. Value in Health 2022; 25: 1663–1672.
2.
Benchimol EI, Smeeth L, Guttmann A, et al. The REporting of studies conducted using observational routinely-collected health data (RECORD) statement. PLoS medicine 2015; 12: e1001885.
3.
Von Elm E, Altman DG, Egger M, et al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: Guidelines for reporting observational studies. International journal of surgery 2014; 12: 1495–1499.
4.
Wang SV, Pottegård A. Advancing research transparency and reproducibility in pharmacoepidemiology. Pharmacoepidemiology and Drug Safety 2025; 34: e70096.
5.
US food and drug administration. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products. 2023. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug.
6.
Abbasi K. A commitment to act on data sharing. BMJ 2023; 382: p1609. Available at: https://www.bmj.com/content/382/bmj.p1609.