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Review
. 2025 Oct;14(10):e250041.
doi: 10.57264/cer-2025-0041. Epub 2025 Aug 21.

Transportability of nonlocal real-world evidence and its relevance to health technology assessment: a primer

Alind Gupta  1   2 , Stephen Duffield  3 , Cal Shephard  4 , Eon Ting  4 , Sanjay Popat  5 , Winson Y Cheung  2   6 , Paul Arora  1   2
Affiliations
Review

Transportability of nonlocal real-world evidence and its relevance to health technology assessment: a primer

Alind Gupta et al. J Comp Eff Res. 2025 Oct.

Abstract

Real-world evidence (RWE) from outside Canada or the UK is sometimes included in submissions to health technology assessments by Canada's Drug Agency/L'Agence des médicaments du Canada (CDA-AMC) and National Institute for Health and Care Excellence when local data are lacking, particularly in rare diseases. However, differences in population demographics, healthcare systems and clinical practice patterns between different jurisdictions can pose challenges for contextualizing nonlocal data for health technology assessments. This primer outlines the challenges of using nonlocal RWE for decision-making, presents assumptions necessary for transportability of RWE, and describes quantitative methods to address these challenges. This primer is written for a broad audience, including industry stakeholders, researchers and clinicians, who are seeking accessible guidance on the use of nonlocal RWE and developments in the field of transportability.

Keywords: generalizability; health technology assessment; real-world evidence; transportability.

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Conflict of interest statement

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript.

Figures

Figure 1.
Figure 1.. Visualization of generalizability and transportability.
In some cases, such as the one shown below for transportability, the target population may include individuals not represented in the study population (green individuals). In these cases, external information may be required to complement data from the study population to achieve transportability. Colors represent heterogeneity in prognosis or response to treatment.
Figure 2.
Figure 2.. Change in number of published generalizability and transportability studies over time.
Figure 3.
Figure 3.. Conceptual overview of how transportability analysis works.
Here an example is shown of transportability from US to UK.
See this image and copyright information in PMC

References

    1. Liu F, Panagiotakos D. Real-world data: a brief review of the methods, applications, challenges, and opportunities. BMC Med. Res. Methodol. 22, 287 (2022). - PMC - PubMed
    1. Makady A, Ten Ham R, de Boer A, Hillege H, Klungel O, Goettsch W. Policies for use of real-world data in health technology assessment (HTA): a comparative study of six HTA agencies. Value Health 20(4), 520–532 (2017). - PubMed
    1. Stuart EA, Bradshaw CP, Leaf PJ. Assessing the generalizability of randomized trial results to target populations. Prev. Sci. 16(3), 475–485 (2015). - PMC - PubMed
    1. Degtiar I, Rose S. A review of generalizability and transportability. Annu. Rev. Stat. Appl. 10, 501–524 (2023).

    2. • Provides a comprehensive and accessible review of generalizability and transportability concepts and methods, making it a cornerstone reference for applying these frameworks in real-world data (RWD) and health technology assessment (HTA) contexts.

    1. National Institute for Health and Care Excellence. NICE real-world evidence framework corporate document [ECD9]. Available at: https://www.nice.org.uk/corporate/ecd9/chapter/overview - PMC - PubMed

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