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Factors affecting the feasibility of post-authorisation RCTs for conditionally authorised anticancer medicines: a multistakeholder perspective from a qualitative focus group study.

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Title: Factors affecting the feasibility of post-authorisation RCTs for conditionally authorised anticancer medicines: a multistakeholder perspective from a qualitative focus group study.
Authors: van Hattem CC; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.; Medicines Evaluation Board, Utrecht, the Netherlands., de Jong AJ; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands., de Groot JS; Medicines Evaluation Board, Utrecht, the Netherlands., Hoekman J; Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, the Netherlands., Broekman KE; Medicines Evaluation Board, Utrecht, the Netherlands.; Department of Medical Oncology, University Medical Centre Groningen, Groningen, the Netherlands., Sonke GS; Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Department of Medical Oncology, University of Amsterdam, Amsterdam, the Netherlands., van Hennik PB; Medicines Evaluation Board, Utrecht, the Netherlands., Bloem LT; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands L.T.Bloem@uu.nl.
Source: BMJ open [BMJ Open] 2024 Nov 09; Vol. 14 (11), pp. e084483. Date of Electronic Publication: 2024 Nov 09.
Publication Type: Journal Article
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
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  Data: <searchLink fieldCode="AU" term="%22van+Hattem+CC%22">van Hattem CC</searchLink>; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.; Medicines Evaluation Board, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22de+Jong+AJ%22">de Jong AJ</searchLink>; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22de+Groot+JS%22">de Groot JS</searchLink>; Medicines Evaluation Board, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Hoekman+J%22">Hoekman J</searchLink>; Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Broekman+KE%22">Broekman KE</searchLink>; Medicines Evaluation Board, Utrecht, the Netherlands.; Department of Medical Oncology, University Medical Centre Groningen, Groningen, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Sonke+GS%22">Sonke GS</searchLink>; Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.; Department of Medical Oncology, University of Amsterdam, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22van+Hennik+PB%22">van Hennik PB</searchLink>; Medicines Evaluation Board, Utrecht, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Bloem+LT%22">Bloem LT</searchLink>; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands L.T.Bloem@uu.nl.
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              Text: 2024 Nov 09
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