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Lung Cancer Treatments and Mutations · Journal article
Clinical Pharmacology & Therapeutics · September 7, 2026
A consensus or society position rather than new primary data.
This guidance document presents a consensus-developed core dataset specification comprising 73 variables across five domains (patient characteristics, disease factors, treatment details, outcomes, and patient-reported measures) designed to standardize real-world data collection for NSCLC drug evaluation. The dataset aims to support regulatory, health technology assessment, and clinical decision-making in the context of small-population and single-arm trials by providing a fit-for-purpose framework for registry-based real-world evidence generation.
Literature review and multi-stakeholder expert consensus process. Expert stakeholders: Dutch clinicians, hospital pharmacists, regulatory authorities, health technology assessment bodies, industry representatives, academics, and a patient representative; target population is non-small cell lung cancer patients in registry contexts. Intervention: Development of a core dataset specification for standardized real-world data collection in NSCLC drug evaluation. Netherlands (expert panel composition indicated as Dutch).
Core dataset includes 6 general patient characteristic variables 19 disease-specific factor variables identified 22 treatment detail variables covering systemic therapy, surgery, and radiotherapy
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This core dataset provides clinicians and healthcare systems with a standardized framework for collecting real-world data that aligns with regulatory and HTA requirements, potentially improving the evidence base for NSCLC drug evaluation in contexts where traditional large randomized trials are infeasible. Adoption may facilitate more robust comparative effectiveness assessment and appropriate therapeutic use.
This is a consensus-derived core dataset specification developed through systematic literature review and multi-stakeholder expert meetings to standardize real-world data collection for NSCLC drug evaluation.
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Quoted from the source exactly as published.
This core dataset provides clinicians and healthcare systems with a standardized framework for collecting real-world data that aligns with regulatory and HTA requirements, potentially improving the evidence base for NSCLC drug evaluation in contexts where traditional large randomized trials are infeasible. Adoption may facilitate more robust comparative effectiveness assessment and appropriate therapeutic use.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Considering the high unmet medical need in people with non-small cell lung cancer (NSCLC), the drug assessment for targeted therapies often rely on small populations and single-arm trials, challenging the evaluation by regulatory authorities, health technology assessment bodies (HTAb), and clinicians. Registry-based real-world data (RWD) can enhance the evaluation and appropriate use of these novel medicines. Therefore, we developed a core dataset that provides a starting point to complement the evaluation of NSCLC drug effects based on registry-based RWD. The core dataset was developed through a literature review of existing core datasets, followed by two multi-stakeholder expert meetings for better understanding of important variables for drug evaluation purposes by different stakeholders. The experts included Dutch clinicians, hospital pharmacists, regulators, HTAb, industry representatives, academics, and a patient representative. Following the literature review, four existing core datasets were identified and used to extract important variables. After two expert meetings, this core dataset was redefined and the final core dataset includes general patient characteristics (n = 6), disease-specific factors (n = 19), treatment details, including systemic therapy, surgery, and radiotherapy (n = 22), outcomes such as death, progression, response (n = 9), and patient-reported outcome measures (n = 17). This core dataset contains relevant variables that provides guidance for the collection of RWD to develop a relevant patient registry for NSCLC and to enhance its fitness-for-purpose. These RWD are intended to address most regulatory, HTA, and healthcare professionals' questions, thereby supporting the generation of real-world evidence for the more appropriate use of NSCLC drugs.
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