COMET Initiative | Toward fit-for-purpose data for drug assessment in non-small cell lung cancer: the core dataset

Toward fit-for-purpose data for drug assessment in non-small cell lung cancer: the core dataset

This core dataset contains relevant variables that provides guidance for the collection of real-world data (RWD) to develop a relevant non-small cell lung cancer (NSCLC) patient registry and to enhance its fitness-for-purpose data. These RWD are intended to address most regulatory, health technology assessment (HTA), and healthcare questions, thereby supporting the generation of real-world evidence for the more appropriate use of NSCLC drugs.

Potentially relevant COS
Existing COS intended to assess the value of lung cancer drugs to support the structured collection of these data in clinical practice were searched in the COMET database. No COS were found that fully met our scope, nevertheless, two relevant lung cancer COS were included in our study to serve as the foundation of our core dataset. The aim of our core dataset differs from these two COS, since they focus on value-based healthcare across the entire treatment pathway (e.g. diagnostics, time to first treatment) for lung cancer patients, while we focus on drug assessment in NSCLC using registry based RWD.
1) K.S. Mak, et al. Defining a standard set of patient-centred outcomes for lung cancer, European Respiratory Journal 48 (2016) 852–860.
2) B.H. de Rooij, et al. Development of an updated, standardized, patient-centered outcome set for lung cancer, Lung Cancer 173 (2022) 5–13.

Contributors

Geeske F Grit, Maaike van Dartel, Laura Rodwell, Hanneke van der Woude, Cornelis Boersma, Peter GM Mol (supervisor), Doranne Hilarius (supervisor)

Further Study Information

Current Stage: Completed – pending publication
Date: December 2023 - 2025
Funding source(s): This study is funded by the European Union’s Horizon Europe Research and Innovation Actions under grant no. 101095479 (More-EUROPA). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union nor the granting authority. Neither the European Union nor the granting authority can be held responsible for them.

Health Area

Disease Category: Cancer

Disease Name: Non-small-cell lung cancer (NSCLC)

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Drug

Stakeholders Involved

- Clinical experts
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Regulatory agency representatives
- Researchers

Study Type

- COS for registry

Method(s)

- Literature review
- Semi structured discussion

The core dataset was developed through a literature review of existing core datasets, followed by two multi-stakeholder expert meetings to provide input for better understanding of important variables.

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