{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T18:52:47Z","timestamp":1791571967337,"version":"4.3.4"},"reference-count":55,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Med Internet Res"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n The pharmaceutical industry faces unprecedented challenges, including declining drug approval rates, plummeting research and development returns, and escalating protocol complexity. Digital transformation represents the most promising end-to-end approach for addressing these challenges, yet there is limited understanding of industry-wide priorities and implementation barriers.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aimed to identify digital transformation priorities across diverse pharmaceutical industry stakeholders and to explore the specific barriers preventing successful implementation through a collaborative, mixed methods approach.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n The study used a sequential mixed methods design with three phases: (1) workshop 1 in Copenhagen, Denmark, with 47 participants randomly divided into 3 working groups, all discussing three main theme areas and generating 110 digital transformation topics; (2) a follow-up online survey of workshop 1 participants (administered 4 wk after workshop 1); and (3) workshop 2 in Boston, United States, with expert keynote and panel discussions exploring implementation challenges. Participants were recruited via convenience sampling through industry networks and professional associations. The study was conducted between March 2023 and June 2025 across international workshop sites in Copenhagen and Boston. Data sources included workshop outputs, survey responses, and transcribed panel discussions. Analysis involved thematic coding, convergence analysis, and tension identification.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Workshop\u202f1 identified 19 common categories across all working groups, despite the 3 diverse starting themes. Workshop 1 produced 7 consolidated categories for theme 1 (desired outcomes), 5 for theme 2 (pathways), and 7 for theme 3 (measuring success), totaling 19 consolidated categories. The survey achieved a 55.3% (26\/47 participants) response rate and identified patient-centered outcomes, FAIR (Findable, Accessible, Interoperable, and Reusable)\u2013aligned data practices, collaboration, access and equity, and the reduction of patient burden as leading priorities. Workshop 2 identified 5 key implementation tensions: innovation speed vs safety standards, collaboration vs competition, technology vs change management, patient preferences vs operational efficiency, and data democratization vs privacy protection. Panel discussions provided deep insights into implementation challenges and solutions. The results obtained support exploratory generalization across comparable settings and do not establish causal effects.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The pharmaceutical industry demonstrates strong consensus on patient-centric digital transformation priorities across the value chain, with universal recognition of the need for precompetitive collaboration. However, significant implementation barriers exist beyond technology, requiring integrated approaches to organizational change, regulatory innovation, and industry-wide standards development. Panel discussions and expert insights provide a pathway for continued collaboration and knowledge sharing. An incremental approach to sharing industry-wide knowledge is further recommended.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/91531","type":"journal-article","created":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T21:10:05Z","timestamp":1789679405000},"page":"e91531-e91531","source":"Crossref","is-referenced-by-count":0,"title":["Priorities and Implementation Barriers in End-to-End Digital Transformation in the Pharmaceutical Industry: Sequential Mixed Methods Analysis"],"prefix":"10.2196","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1787-8381","authenticated-orcid":false,"given":"Isaac Rogelio","family":"Rodriguez-Chavez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-2541-7701","authenticated-orcid":false,"given":"Adama","family":"Ibrahim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-1442-1535","authenticated-orcid":false,"given":"Baris","family":"Ersezer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-3716-2555","authenticated-orcid":false,"given":"Angela","family":"Radcliffe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4236-5684","authenticated-orcid":false,"given":"Victoria","family":"Gamerman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6631-2379","authenticated-orcid":false,"given":"Bert","family":"Hartog","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0558-3392","authenticated-orcid":false,"given":"Lars Fogh","family":"Iversen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-3016-5366","authenticated-orcid":false,"given":"Marcus","family":"Schindler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,10,9]]},"reference":[{"issue":"5","key":"R1","doi-asserted-by":"publisher","first-page":"855","DOI":"10.1007\/s43441-024-00667-w","article-title":"New estimates on the cost of a delay day in drug development","volume":"58","author":"Smith","journal-title":"Ther Innov Regul Sci"},{"issue":"1","key":"R2","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1177\/2168479017713039","article-title":"New benchmarks characterizing growth in protocol design complexity","volume":"52","author":"Getz","journal-title":"Ther Innov Regul Sci"},{"issue":"5","key":"R3","doi-asserted-by":"publisher","first-page":"450","DOI":"10.1097\/MJT.0b013e31816b9027","article-title":"Assessing the impact of protocol design changes on clinical trial performance","volume":"15","author":"Getz","journal-title":"Am J Ther"},{"issue":"4","key":"R4","doi-asserted-by":"publisher","first-page":"436","DOI":"10.1177\/2168479016632271","article-title":"The impact of protocol amendments on clinical trial performance and cost","volume":"50","author":"Getz","journal-title":"Ther Innov Regul Sci"},{"key":"R5","unstructured":"Digital transformation in life sciences. 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