2022
DOI: 10.1001/jamanetworkopen.2022.39874
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Transportability of Overall Survival Estimates From US to Canadian Patients With Advanced Non–Small Cell Lung Cancer With Implications for Regulatory and Health Technology Assessment

Abstract: ImportanceThe external validity of survival outcomes derived from clinical practice data from US patients with advanced non–small cell lung cancer (NSCLC) is not known and is of potential importance because it may be used to support regulatory decision-making and health technology assessment outside of the US.ObjectiveTo evaluate whether overall survival (OS) estimates for a selected group of patients with advanced NSCLC from a large US clinical practice database are transportable to Canadian patients receivin… Show more

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Cited by 10 publications
(5 citation statements)
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“…With real-world data becoming increasingly available, generalizability and transportability studies can be an excellent source of real-world evidence that warrants more attention from the regulatory agencies. 89 Real-world evidence based on generalizability and transportability studies should be used in conjunction with other evidence generated from clinical trials, pragmatic trials, and other observational studies, where internal and external validity are considered jointly. 20 , 33 Investigators need to be diligent about reconciling any differences among their various sources of evidence by considering study design and other practical constraints (e.g., data availability).…”
Section: Discussionmentioning
confidence: 99%
“…With real-world data becoming increasingly available, generalizability and transportability studies can be an excellent source of real-world evidence that warrants more attention from the regulatory agencies. 89 Real-world evidence based on generalizability and transportability studies should be used in conjunction with other evidence generated from clinical trials, pragmatic trials, and other observational studies, where internal and external validity are considered jointly. 20 , 33 Investigators need to be diligent about reconciling any differences among their various sources of evidence by considering study design and other practical constraints (e.g., data availability).…”
Section: Discussionmentioning
confidence: 99%
“…However, the reality is that clinical trials, including RCTs, cannot be conducted in every country to generate specific evidence for that country's population. Evidence generation using transportability analysis is gaining traction and refers to the ability to generalize inferences from a study sample in one country to a target population in another country where the study was not conducted 47,48 . Transportability analyses may offer some evidence of external validity with implications for local regulatory and health technology assessments 48 .…”
Section: Globalizing Drug Development Harmonization and Transportabilitymentioning
confidence: 99%
“…For another, harmonizing data can allow researchers to assess the generalizability or transportability of a given finding 85 , 86 . Note that while the two terms are closely related, generalizability refers to whether causal effects can travel from the sample to the population under question (e.g.…”
Section: What Tradeoffs Should Be Considered When Harmonizing Data?mentioning
confidence: 99%