{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T13:08:35Z","timestamp":1788786515509,"version":"build-2803163510"},"reference-count":44,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T00:00:00Z","timestamp":1788739200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T00:00:00Z","timestamp":1788739200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"abstract":"<jats:p>\n                    Considering the high unmet medical need in people with non\u2010small cell lung cancer (NSCLC), the drug assessment for targeted therapies often rely on small populations and single\u2010arm trials, challenging the evaluation by regulatory authorities, health technology assessment bodies (HTAb), and clinicians. Registry\u2010based real\u2010world 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\u2010based RWD. The core dataset was developed through a literature review of existing core datasets, followed by two multi\u2010stakeholder 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                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20096), disease\u2010specific factors (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200919), treatment details, including systemic therapy, surgery, and radiotherapy (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200922), outcomes such as death, progression, response (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20099), and patient\u2010reported outcome measures (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200917). 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\u2010for\u2010purpose. These RWD are intended to address most regulatory, HTA, and healthcare professionals' questions, thereby supporting the generation of real\u2010world evidence for the more appropriate use of NSCLC drugs.\n                  <\/jats:p>","DOI":"10.1002\/cpt.70473","type":"journal-article","created":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T12:18:50Z","timestamp":1788783530000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Toward Fit\u2010for\u2010Purpose Data for Drug Assessment in Non\u2010small Cell Lung Cancer: A Core Dataset"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-1734-7950","authenticated-orcid":false,"given":"Geeske F.","family":"Grit","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacology University Medical Center Groningen  Groningen The Netherlands"},{"name":"Dutch Institute for Clinical Auditing  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maaike","family":"van Dartel","sequence":"additional","affiliation":[{"name":"Dutch Medicines Evaluation Board  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Rodwell","sequence":"additional","affiliation":[{"name":"Q Health Department Radboud University Medical Center  Nijmegen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanneke","family":"van der Woude","sequence":"additional","affiliation":[{"name":"Dutch Medicines Evaluation Board  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelis","family":"Boersma","sequence":"additional","affiliation":[{"name":"Unit of Global Health, Department of Health Science University Medical Center Groningen  Groningen the Netherlands"},{"name":"Faculty of Management Sciences Open University  Heerlen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4262-3180","authenticated-orcid":false,"given":"Peter G. M.","family":"Mol","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacology University Medical Center Groningen  Groningen The Netherlands"},{"name":"Dutch Medicines Evaluation Board  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doranne","family":"Hilarius","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Rode Kruis Ziekenhuis  Beverwijk The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,7]]},"reference":[{"key":"e_1_2_10_1_1","unstructured":"World Health Organisation Cancer Today(2022) <https:\/\/gco.iarc.fr\/today\/home>."},{"key":"e_1_2_10_2_1","unstructured":"American Cancer Society Key Statistics for Lung Cancer(2025) 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