Target Trial Emulation in HTA RWD Submissions: A Best Practice Not Embraced – Methodological Challenge or Manufacturers' Reluctance?

Speaker(s)

Moderator: Sreeram Ramagopalan, PhD, Health Analytics, Lane Clark & Peacock, London, LON, UK
Panelists: Alejandra Castanon, MD, MSc, PhD, Health Analytics, Lane Clark and Peacock, London, UK; Stephen Duffield, PhD, MD, National Institute for Health and Care Excellence, Liverpool, LAN, UK; Rob Reynolds, PhD, GSK, New York, NY, USA

Presentation Documents

ISSUE:

Health Technology Assessment (HTA) agencies, like NICE, have recognized target trial emulation (TTE) as an exemplar of best practice in the analysis of real-world data (RWD). Yet, a significant gap exists between this endorsement and its practical application in submissions. This raises questions: Is TTE an idealistic methodology, challenging to apply in real-world scenarios, or are manufacturers opting for shortcuts?

OVERVIEW:

Topics and Speakers:

Chair: Sreeram Ramagopalan, Lane Clark and Peacock, UK

  • Demystifying Target Trial Emulation
    • Speaker: Alejandra Castanon, Lane Clark and Peacock, UK
    • Summary: Alejandra will cover the rationale, benefits, and methodological intricacies of the TTE approach for RWD study design. Whilst TTE provides a framework for causal inference from RWD, it requires high quality RWD and careful considerations of assumptions.

  • The HTA Viewpoint: Expectations and Discrepancies in Submissions
    • Speaker: Stephen Duffield, NICE, UK
    • Summary: Stephen will shed light on the HTA perspective regarding TTE why it was endorsed as best practice and the potential consequences of not following this best practice in submissions. Stephen will also discuss the gap currently between HTA agency expectations and actual submissions.

  • Operational Challenges: The Pharmaceutical Industry's Take on Target Trial Emulation
    • Speaker: Rob Reynolds, GSK, US
    • Summary: Rob Reynolds will address the elephant in the room – is TTE realistically feasible? Rob will delve into the practical challenges and potential barriers faced by manufacturers in implementing this method.
This panel will offer a 360-degree view of the topic of TTE in the context of RWD submissions for HTA. Attendees will gain a foundational understanding of the method, hear first hand the expectations of HTA agencies, and get insights into the implementation challenges faced by the pharmaceutical industry. The session promises a holistic discourse that aims to bridge the gap between ideal methodologies and their real-world application in health technology assessment.

Code

107

Topic

Real World Data & Information Systems