Hot Topic Session: How Can We Mitigate Publication of Poorly Conducted RWE Studies? Keynote Session [Plenary]

Background
The growing acceptance of RWE in clinical and regulatory decision-making as well as the increasing availability of healthcare data coupled with automated analytic approaches have contributed to a marked expansion of RWE studies. Commensurate with this, there has been increasing concern about inappropriate applications of RWE, violating causal inference principles with inappropriate use of data and methods. At the height of the 2020s COVID-19 pandemic, urgency for data elucidating the effects of various COVID-19 treatments may have created additional pressure to relax standards regarding the level and rigor of scientific review, resulting in "pandemic-related research waste", including two papers published in, and then retracted from, NEJM and The Lancet.

Objectives
This symposium will discuss ways that we as pharmacoepidemiologists can contribute to better governance of RWE studies, including appropriate study conduct, transparency, publication and peer review.

Description
The symposium will start with 5 presentations (10-12 min each) on the topic followed by a panel discussion.
1.

Overview: The big sick: the rise of data-driven versus design-driven RWE studies and research waste (A Winterstein)
2. The big cure 1: how can we mitigate publication of poorly conducted RWE studies – training non-pharmacoepidemiologists in good p-epi practice (T Stuermer)
3. The big cure 2: a priori study protocols, author and reviewer expertise (M Smith)
4. The big cure Part 3: checklists and guidances (V Ehrenstein)
5. The big cure Part 4: Data provenance and custodianship (J Brown)

The subsequent panel discussion will include representatives from medical journals (Jodi Segal, Johns Hopkins University) developers of RWE publication checklists and protocol registration initiatives (Shirley Wang, Harvard university), real-world database developers (John Seeger, Optum), and ISPE leads involved with educational initiatives (Tobias Gerhard, Rutgers University).

Questions that will be directed at the panel for discussion include:
1. How and when can we foster registration of detailed a priori protocols?
2. How can we improve the peer review process and what is the role of guidances and checklists?
3. What's ISPE's role in educating clinical audiences and data scientists?
4. How can we ensure adequate data(base) provenance, transparency and fit for purpose?