SW-2E - Resolved That the Hierarchy of Evidence Should Be Replaced: A Debate

Background: As use of RWE for regulatory decision-making increases, the types of clinical data and evidence generated for medical products are changing. Consideration of how to interpret these studies within regulatory and clinical contexts is critical. The evidence-based medicine hierarchy of evidence has poor consideration for the relevance and reliability of the data to generate high quality evidence. Even the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) assessment assumes that randomization leads to initial “high quality” grading and cohorts are initially “low quality” studies – though, aspects of study design and conduct may change these rankings. It is time to consider whether a new evidence framework is needed.

Objectives: To debate aspects of clinical evidence generation that increase or decrease the quality of study findings. To determine whether a new framework for quality evidence is needed.

Description: Resolved: The hierarchy of evidence should be replaced by a framework that more readily accounts for data quality of study findings in addition to study design quality.
This debate will present positions for and against changing the historical “hierarchy of evidence” used for evidence based medicine. Specific topics for the point-counterpoint discussion will be:
• Bias and uncertainty in poorly constructed/conducted randomized trials vs well-designed and executed cohort studies
• Considerations for integration of causal inference methods, intercurrent events, and target trial emulation into evidence framework
• Ease of understanding the framework by novice practitioners (e.g., medical and pharmacy students) and ease of use for determining study quality
• Application of the evidence framework in regulatory approvals and clinical practice guidelines
• Impact of technological advancements (e.g., AI and machine learning) on evidence generation and evaluation

Using formal debate styling, the affirmative (pro change) team (Kirk Geale, Christina Mack) will have 10 minutes to open the debate, followed by 10 min opening statement from the opposing (keep hierarchy) team (TBD, Lisa Weiss). The second speakers of each team will have 5 min to rebut a specific point of conflict from the opening statements. After an audience poll, two additional statements per team (5 min each) will present supportive points to their position or as rebuttal to previous statements of the other team. Another audience poll will be followed by commentary/ questions from the audience (20-25 min). A final poll will determine the debate winner and the session will be summarized by the moderator (Mary Beth Ritchey).