{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,27]],"date-time":"2026-06-27T06:35:53Z","timestamp":1782542153818,"version":"3.54.5"},"reference-count":47,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T00:00:00Z","timestamp":1740528000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T00:00:00Z","timestamp":1740528000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>This paper describes the planning of a patient preference study for evaluating device features for the subcutaneous (SC) delivery of high dose\/large volume (e.g.,\u2009&gt;\u20092\u00a0ml) of drugs. Multiple sources, including qualitative patient interviews, the involvement of patient partners, and solicitation of advice from the US Food and Drugs Administration (FDA), were used to refine the attributes and levels in the development of a preference study protocol to investigate what Multiple Sclerosis (MS) patients consider important regarding medical device features for high dose SC administration.<\/jats:p>","DOI":"10.1007\/s43441-024-00725-3","type":"journal-article","created":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T13:40:37Z","timestamp":1740577237000},"page":"579-595","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient Perspectives"],"prefix":"10.1007","volume":"59","author":[{"given":"Marie","family":"Picci","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nigel S.","family":"Cook","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Byron","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mo","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Conny","family":"Berlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Sturchler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clemence","family":"Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Garcia Baena","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Ziegler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harriet","family":"Gaunt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brad","family":"Mason","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Hamerlijnck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiyuki","family":"Majima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,2,26]]},"reference":[{"key":"725_CR1","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1007\/s43441-023-00573-7","volume":"10","author":"N Bertelsen","year":"2023","unstructured":"Bertelsen N, Dewulf L, Ferr\u00e8 S, et al. Patient engagement and patient experience data in regulatory review and health technology assessment: a global landscape review. Ther Innov Regul Sci. 2023;10:6\u20139. https:\/\/doi.org\/10.1007\/s43441-023-00573-7.","journal-title":"Ther Innov Regul. Sci."},{"key":"725_CR2","unstructured":"Eastern Research Group. Assessment of the Use of Patient Experience Data in Regulatory Decision-Making \u2013 Final Report, June 18, (2021) https:\/\/www.fda.gov\/media\/150405\/download?attachment. Downloaded: 31 October 2023."},{"issue":"2","key":"725_CR3","doi-asserted-by":"publisher","first-page":"147","DOI":"10.1007\/s40271-023-00653-8","volume":"17","author":"CA Pinto","year":"2024","unstructured":"Pinto CA, Tervonen T, Jimenez-Moreno C, et al. Current practices and challenges when submitting patient experience data for regulatory decisions by the United States food and drug administration: an industry survey. Patient. 2024;17(2):147\u201359.","journal-title":"Patient"},{"key":"725_CR4","unstructured":"FDA, Patient-Focused Drug Development Glossary | FDA 2018."},{"key":"725_CR5","unstructured":"MDIC Medical Device Innovation Consortium (MDIC) patient centered benefit-risk project report: A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology 2015 https:\/\/mdic.org\/resource\/patient-centered-benefit-risk-pcbr-framework\/."},{"key":"725_CR6","doi-asserted-by":"publisher","unstructured":"PREFER PREFER Recommendations - Why, when and how to assess and use patient preferences in medical product decision-making. Zenodo. 19 April 2022. Accessed on 11 July 2023. https:\/\/doi.org\/10.5281\/zenodo.6470922.","DOI":"10.5281\/zenodo.6470922"},{"key":"725_CR7","unstructured":"EMA, Qualification Opinion of IMI PREFER. EMA webpage. 03 May 2022. qualification-opinion-imi-prefer_en.pdf (europa.eu)."},{"issue":"2","key":"725_CR8","doi-asserted-by":"publisher","first-page":"145","DOI":"10.1007\/s40271-019-00408-4","volume":"13","author":"JC Bouvy","year":"2020","unstructured":"Bouvy JC, Cowie L, Lovett R, et al. Use of patient preference studies in HTA decision making: a NICE perspective. Patient. 2020;13(2):145\u20139.","journal-title":"Patient"},{"key":"725_CR9","doi-asserted-by":"publisher","first-page":"00686","DOI":"10.1183\/23120541.00686-2021","volume":"8","author":"NS Cook","year":"2022","unstructured":"Cook NS, Criner GJ, Burgel P-R, et al. People living with moderate-to-severe COPD prefer improvement of daily symptoms over the improvement of exacerbations: a multi-country patient preference study. ERJ Open Res. 2022;8:00686\u20132021. https:\/\/doi.org\/10.1183\/23120541.00686-2021.","journal-title":"ERJ Open Res"},{"key":"725_CR10","doi-asserted-by":"publisher","first-page":"345","DOI":"10.1007\/s40271-023-00617-y","volume":"16","author":"S Tatlock","year":"2023","unstructured":"Tatlock S, Sully K, Batish A, et al. Individual differences in the patient experience of relapsing multiple sclerosis (RMS): a multi-country qualitative exploration of drivers of treatment preferences among people living with RMS. Patient. 2023;16:345\u201357. https:\/\/doi.org\/10.1007\/s40271-023-00617-y.","journal-title":"Patient"},{"key":"725_CR11","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/1346-8138.17056","volume":"00","author":"T Tervonen","year":"2023","unstructured":"Tervonen T, Whichello C, Law E, et al. Treatment preferences of adults and adolescents with alopecia areata: a discrete choice experiment. J Dermatol. 2023;00:1\u201310. https:\/\/doi.org\/10.1111\/1346-8138.17056.","journal-title":"J Dermatol"},{"key":"725_CR12","unstructured":"Apostolaros, M.A., Bent, R., Coulter, J. et al. Maximizing the impact of patient-centric data: meaningful interactions informing regulatory decision-making. RAPS Convergence Conference, Montreal, Canada, 3\u20135 October 2023. https:\/\/convergence2023.eventscribe.net\/agenda.asp?startdate=10\/4\/2023&enddate=10\/4\/2023&BCFO=&pfp=BrowsebyDay&mode=&fa=&fb=&fc=&fd=."},{"key":"725_CR13","first-page":"473","volume":"8","author":"C Berteau","year":"2015","unstructured":"Berteau C, Filipe-Santos O, Wang T, et al. Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance. Med Devices (Auckl). 2015;8:473\u201384.","journal-title":"Med Devices (Auckl)"},{"key":"725_CR14","doi-asserted-by":"publisher","first-page":"2255","DOI":"10.1016\/j.xphs.2016.05.029","volume":"105","author":"R Mathaes","year":"2016","unstructured":"Mathaes R, Koulov A, Joerg S, et al. Subcutaneous injection volume of biopharmaceuticals; pushing the boundaries. J Pharm Sci. 2016;105:2255\u20139.","journal-title":"J Pharm Sci"},{"issue":"15","key":"725_CR15","doi-asserted-by":"publisher","first-page":"811","DOI":"10.2147\/PPA.S303279.PMID:33907384;PMCID:PMC8064718","volume":"19","author":"PM Overton","year":"2021","unstructured":"Overton PM, Shalet N, Somers F, et al. Patient preferences for subcutaneous versus intravenous administration of treatment for chronic immune system disorders: a systematic review. Patient Prefer Adherence. 2021;19(15):811\u201334. https:\/\/doi.org\/10.2147\/PPA.S303279.PMID:33907384;PMCID:PMC8064718.","journal-title":"Patient Prefer Adherence"},{"issue":"1","key":"725_CR16","doi-asserted-by":"publisher","first-page":"119","DOI":"10.1007\/s40271-017-0276-2.PMID:28956281;PMCID:PMC5766732","volume":"11","author":"E Dashiell-Aje","year":"2018","unstructured":"Dashiell-Aje E, Harding G, Pascoe K, et al. Patient evaluation of satisfaction and outcomes with an autoinjector for self-administration of subcutaneous belimumab in patients with systemic lupus erythematosus. The Patient. 2018;11(1):119\u201329. https:\/\/doi.org\/10.1007\/s40271-017-0276-2.PMID:28956281;PMCID:PMC5766732.","journal-title":"The Patient"},{"key":"725_CR17","doi-asserted-by":"publisher","first-page":"836","DOI":"10.1093\/annonc\/mdw685","volume":"28","author":"M Rummel","year":"2017","unstructured":"Rummel M, Kim TM, Aversa F, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28:836\u201342.","journal-title":"Ann Oncol"},{"key":"725_CR18","doi-asserted-by":"crossref","first-page":"178","DOI":"10.3324\/haematol.2014.114405","volume":"100","author":"P Lugtenburg","year":"2015","unstructured":"Lugtenburg P, Rueda A, Avivi I, et al. Subcutaneous versus intravenous rituximab in combination with chop for previously untreated diffuse large B-cell lymphoma: efficacy and safety results from the phase iiib mabease study. Haematologica. 2015;100:178\u20139.","journal-title":"Haematologica"},{"key":"725_CR19","first-page":"923","volume":"9","author":"JF Jin","year":"2015","unstructured":"Jin JF, Zhu LL, Chen M, et al. The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection. Patient Prefer Adherence. 2015;9:923\u201342.","journal-title":"Patient Prefer Adherence"},{"key":"725_CR20","doi-asserted-by":"publisher","first-page":"962","DOI":"10.1016\/S1470-2045(13)70383-8","volume":"14","author":"X Pivot","year":"2013","unstructured":"Pivot X, Gligorov J, M\u00fcller V, et al. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013;14:962\u201370.","journal-title":"Lancet Oncol"},{"key":"725_CR21","doi-asserted-by":"publisher","first-page":"3267","DOI":"10.2217\/fon-2019-0368","volume":"15","author":"KC Anderson","year":"2019","unstructured":"Anderson KC, Landgren O, Arend R, et al. A. Humanistic and economic impact of subcutaneous versus intravenous administration of oncology biologics. Future Oncol. 2019;15:3267\u201381.","journal-title":"Future Oncol"},{"key":"725_CR22","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1186\/s12883-023-03100-1","volume":"23","author":"AP Ross","year":"2023","unstructured":"Ross AP, Besser C, Naval S, et al. Patient and nurse preference for Sensoready autoinjector pen versus other autoinjectors in multiple sclerosis: results from a pilot multicenter survey. BMC Neurol. 2023;23:85. https:\/\/doi.org\/10.1186\/s12883-023-03100-1.","journal-title":"BMC Neurol"},{"key":"725_CR23","doi-asserted-by":"publisher","first-page":"1413","DOI":"10.2147\/PPA.S169339","volume":"12","author":"B Tischer","year":"2018","unstructured":"Tischer B, Mehl A. Patients\u2019 and nurses\u2019 preferences for autoinjectors for rheumatoid arthritis: results of a European survey. Patient Prefer Adherence. 2018;12:1413\u201324. https:\/\/doi.org\/10.2147\/PPA.S169339.","journal-title":"Patient Prefer Adherence"},{"key":"725_CR24","doi-asserted-by":"publisher","first-page":"566","DOI":"10.1164\/rccm.200906-0907OC","volume":"181","author":"SR Wilson","year":"2010","unstructured":"Wilson SR, Strub P, Buist AS, et al. Shared treatment decision making improves adherence and outcomes in poorly controlled asthma. Am J Respir Crit Care Med. 2010;181:566\u201377.","journal-title":"Am J Respir Crit Care Med"},{"key":"725_CR25","unstructured":"FDA-CDRH, 2023. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Guidance for Industry and Food and Drug Administration Staff. Document issued on June 2, 2023. https:\/\/www.fda.gov\/media\/114034\/download."},{"issue":"9","key":"725_CR26","first-page":"1408","volume":"20","author":"PI Fusch","year":"2015","unstructured":"Fusch PI, Ness LR. Are we there yet? data saturation in qualitative research. Qual Rep. 2015;20(9):1408\u201316.","journal-title":"Qual Rep"},{"key":"725_CR27","unstructured":"FDA, 2022: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. Patient-focused drug development: methods to identify what is important to patients: guidance for industry, food and drug administration staff, and other stakeholders. 2022. https:\/\/www.fda.gov\/media\/131230\/download."},{"issue":"1","key":"725_CR28","doi-asserted-by":"publisher","first-page":"59","DOI":"10.1177\/1525822x05279903","volume":"18","author":"G Guest","year":"2006","unstructured":"Guest G, Bunce A, Johnson L. How many interviews are enough?: an experiment with data saturation and variability. Field Methods. 2006;18(1):59\u201382. https:\/\/doi.org\/10.1177\/1525822x05279903.","journal-title":"Field Methods"},{"issue":"2","key":"725_CR29","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1191\/1478088706qp063oa","volume":"3","author":"V Braun","year":"2006","unstructured":"Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77\u2013101. https:\/\/doi.org\/10.1191\/1478088706qp063oa.","journal-title":"Qual Res Psychol"},{"key":"725_CR30","doi-asserted-by":"crossref","unstructured":"Willig, C. and Rogers, W.S. The SAGE Handbook of Qualitative Research in Psychology. 55 City Road, London2017. Available from: https:\/\/methods.sagepub.com\/book\/the-sage-handbook-of-qualitative-research-in-psychology-second-edition.","DOI":"10.4135\/9781526405555"},{"key":"725_CR31","unstructured":"ATLAS.ti Scientific Software Development GmbH. (2022). ATLAS.ti for Windows (version 22.2.5.0) [Qualitative data analysis software]. https:\/\/atlasti.com."},{"issue":"4","key":"725_CR32","doi-asserted-by":"publisher","first-page":"514","DOI":"10.1080\/2159676X.2017.1331501","volume":"9","author":"DW Eccles","year":"2017","unstructured":"Eccles DW, Arsal G. The think aloud method: what is it and how do I use it? Qual Res Sport, Exerc Health. 2017;9(4):514\u201331. https:\/\/doi.org\/10.1080\/2159676X.2017.1331501.","journal-title":"Qual Res Sport, Exerc Health"},{"key":"725_CR33","unstructured":"FDA, 2009: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. Guidance for industry: patient-reported outcomes measures: use in medical product development to support labeling claims, December 2009. http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM193282.pdf."},{"key":"725_CR34","unstructured":"National Health Council (2023)-Patient Engagement Fair-Market Value Calculator. https:\/\/nationalhealthcouncil.org\/fair-market-value-calculator\/."},{"key":"725_CR35","unstructured":"FDA 2022b: US Department of Health and Human Services, Food and Drug Administration. Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry. Draft Guidance, April 2022. https:\/\/www.fda.gov\/media\/157635\/download."},{"key":"725_CR36","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1016\/j.jval.2010.11.013","volume":"14","author":"JFP Bridges","year":"2011","unstructured":"Bridges JFP, Hauber AB, Marshall D, et al. Conjoint analysis applications in health\u2013a checklist: a report of the ISPOR good research practices for conjoint analysis task force. Value Health. 2011;14:403\u201313.","journal-title":"Value Health"},{"key":"725_CR37","doi-asserted-by":"publisher","first-page":"82","DOI":"10.3389\/fmed.2019.00082","volume":"6","author":"NS Cook","year":"2019","unstructured":"Cook NS, Cave J, Holtorf A-P. Patient preference studies during early drug development: aligning stakeholders to ensure development plans meet patient needs. Front Med. 2019;6:82. https:\/\/doi.org\/10.3389\/fmed.2019.00082.","journal-title":"Front Med"},{"key":"725_CR38","doi-asserted-by":"publisher","first-page":"152","DOI":"10.1007\/s43441-022-00450-9","volume":"57","author":"L Rincon-Gonzalez","year":"2023","unstructured":"Rincon-Gonzalez L, Selig WKD, Hauber B, et al. Leveraging patient preference information in medical device clinical trial design. Ther Innov Regul Sci. 2023;57:152\u20139. https:\/\/doi.org\/10.1007\/s43441-022-00450-9.","journal-title":"Ther Innov Regul Sci"},{"key":"725_CR39","unstructured":"FDA, 2023. FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient\u2019s Voice in Medical Product Development and Regulatory Decision Making. FDA Webpage. 06 April 2022. Accessed on 30 November 2023. https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical."},{"key":"725_CR40","unstructured":"Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties. https:\/\/www.fda.gov\/media\/181509\/download."},{"key":"725_CR41","doi-asserted-by":"publisher","first-page":"1197","DOI":"10.34067\/KID.0001862022","volume":"3","author":"JE Flythe","year":"2022","unstructured":"Flythe JE, Forfang D, Gedney N, et al. Development of a patient preference survey for wearable kidney replacement therapy devices. Kidney. 2022;3:1197\u2013209. https:\/\/doi.org\/10.34067\/KID.0001862022.","journal-title":"Kidney"},{"issue":"2","key":"725_CR42","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1016\/j.jval.2022.12.004","volume":"26","author":"JFP Bridges","year":"2023","unstructured":"Bridges JFP, de Bekker-Grob EW, Hauber B, et al. A roadmap for increasing the usefulness and impact of patient-preference studies in decision making in health: a good practices report of an ISPOR task force. Value Health. 2023;26(2):153\u201362. https:\/\/doi.org\/10.1016\/j.jval.2022.12.004. (PMID: 36754539).","journal-title":"Value Health"},{"issue":"1","key":"725_CR43","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1186\/s40900-023-00430-9","volume":"9","author":"MY Smith","year":"2023","unstructured":"Smith MY, Janssens R, Jimenez-Moreno AC, et al. Patients as research partners in preference studies: learnings from IMI-PREFER. Res Involv Engagem. 2023;9(1):21. https:\/\/doi.org\/10.1186\/s40900-023-00430-9.","journal-title":"Res Involv Engagem"},{"key":"725_CR44","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1177\/23743735231213767","volume":"10","author":"M Jalowsky","year":"2023","unstructured":"Jalowsky M, Hauber B, Scott MJ, et al. Priority outcomes in sickle cell disease treatment: co-creation and implementation of a preference exercise with patients and caregivers to inform drug development. J Patient Exp. 2023;10:1\u20136. https:\/\/doi.org\/10.1177\/23743735231213767.","journal-title":"J Patient Exp"},{"key":"725_CR45","doi-asserted-by":"publisher","first-page":"93","DOI":"10.3389\/fmed.2020.00093","volume":"7","author":"E Van Overbeeke","year":"2020","unstructured":"Van Overbeeke E, Vanbinst I, Jimenez-Moreno AC, et al. Patient centricity in patient preference studies: the patient perspective. Front Med. 2020;7:93. https:\/\/doi.org\/10.3389\/fmed.2020.00093.","journal-title":"Front Med"},{"key":"725_CR46","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1016\/S1470-2045(20)30536-2","volume":"22","author":"AR Tan","year":"2021","unstructured":"Tan AR, Im SA, Mattar A, et al. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2021;22:85\u201397.","journal-title":"Lancet Oncol"},{"key":"725_CR47","doi-asserted-by":"publisher","first-page":"e370","DOI":"10.1016\/S2352-3026(20)30070-3","volume":"7","author":"MV Mateos","year":"2020","unstructured":"Mateos MV, Nahi H, Legiec W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020;7:e370\u201380. https:\/\/doi.org\/10.1016\/S2352-3026(20)30070-3.","journal-title":"Lancet Haematol"}],"container-title":["Therapeutic Innovation &amp; Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-024-00725-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43441-024-00725-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-024-00725-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T14:50:58Z","timestamp":1745419858000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43441-024-00725-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,26]]},"references-count":47,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["725"],"URL":"https:\/\/doi.org\/10.1007\/s43441-024-00725-3","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-4532442\/v1","asserted-by":"object"}]},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,26]]},"assertion":[{"value":"5 June 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 November 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 February 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Marie Picci, Nigel Cook, Byron Jones, Mo Zhou, Conny Berlin, Christine Sturchler, Clemence Martinez, Irene Garcia Baena and Lauren Ziegler are employed by Novartis and hold Novartis shares. Conny Berlin, Nigel Cook and Byron Jones were also members of the IMI PREFER project. Harriet Gaunt is a full-time employee of Adelphi Research, who received funding from Novartis to draft the FDA briefing document and conduct the post-FDA qualitative interview stage of the study. Brad Mason is a full-time employee of Adelphi Values Patient-Centered Outcomes, who received funding from Novartis to draft the FDA briefing document and conduct the post-FDA qualitative interview stage of the study. Dominique Hamerlijnck is an independent patient expert consultant for Novartis, Chiesi, Pfizer and Roche, mainly on improving patient engagement. None of her family members are employed by Novartis. Yoshiyuki Majima is an independent patient expert consultant for Novartis, representing PanCAN Japan. None of his family members are employed by Novartis.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}