Tyler L Cope, Emily C O'Brien, Neha J Pagidipati, Monica Leyva, Lauren Cohen, Elizabeth Fraulo, Shelby D Reed, Christopher B Granger, Hayden B Bosworth
{"title":"在临床试验中嵌入实施科学:学术与生命科学伙伴关系的框架。","authors":"Tyler L Cope, Emily C O'Brien, Neha J Pagidipati, Monica Leyva, Lauren Cohen, Elizabeth Fraulo, Shelby D Reed, Christopher B Granger, Hayden B Bosworth","doi":"10.1007/s40290-025-00581-y","DOIUrl":null,"url":null,"abstract":"<p><p>Implementation science offers a systematic approach to bridging the gap between research and clinical practice by promoting the adoption, scale-up, and sustainment of evidence-based therapies. Historically, academic implementation science efforts in the USA have focused on later-stage post-market research through government-funded initiatives, leaving untapped opportunities to engage more proactively with life science partners, such as pharmaceutical sponsors, earlier in the development process. Limited integration with life science partners, especially during early-phase clinical trials, represents a missed opportunity to address implementation challenges that affect real-world uptake proactively. The objective of this current opinion is to explore how implementation scientists can more effectively position their expertise to support the development, evaluation, and delivery of new therapies throughout the entire clinical trial lifecycle with life science partners. This article proposes a conceptual framework for collaboration between implementation scientists and life science partners, emphasizing how early integration can help identify healthcare system constraints, clinician adoption barriers, and patient acceptability issues, factors that often shape a therapy's downstream impact. Even before efficacy or regulatory certainty is established, implementation science can strengthen trial design, inform site and stakeholder selection, and enhance the interpretability and readiness of findings for real-world uptake. By aligning implementation methodologies with the strategic priorities of pharmaceutical sponsors, academic researchers can provide structured actionable insights that increase the likelihood of clinical and commercial success. Stronger partnerships established earlier in the development process may improve return on investment, reduce time to impact, and accelerate the translation of effective therapies into routine care.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":""},"PeriodicalIF":4.5000,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Embedding Implementation Science in Clinical Trials: A Framework for Academic-Life Science Partnerships.\",\"authors\":\"Tyler L Cope, Emily C O'Brien, Neha J Pagidipati, Monica Leyva, Lauren Cohen, Elizabeth Fraulo, Shelby D Reed, Christopher B Granger, Hayden B Bosworth\",\"doi\":\"10.1007/s40290-025-00581-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Implementation science offers a systematic approach to bridging the gap between research and clinical practice by promoting the adoption, scale-up, and sustainment of evidence-based therapies. Historically, academic implementation science efforts in the USA have focused on later-stage post-market research through government-funded initiatives, leaving untapped opportunities to engage more proactively with life science partners, such as pharmaceutical sponsors, earlier in the development process. Limited integration with life science partners, especially during early-phase clinical trials, represents a missed opportunity to address implementation challenges that affect real-world uptake proactively. The objective of this current opinion is to explore how implementation scientists can more effectively position their expertise to support the development, evaluation, and delivery of new therapies throughout the entire clinical trial lifecycle with life science partners. This article proposes a conceptual framework for collaboration between implementation scientists and life science partners, emphasizing how early integration can help identify healthcare system constraints, clinician adoption barriers, and patient acceptability issues, factors that often shape a therapy's downstream impact. Even before efficacy or regulatory certainty is established, implementation science can strengthen trial design, inform site and stakeholder selection, and enhance the interpretability and readiness of findings for real-world uptake. By aligning implementation methodologies with the strategic priorities of pharmaceutical sponsors, academic researchers can provide structured actionable insights that increase the likelihood of clinical and commercial success. Stronger partnerships established earlier in the development process may improve return on investment, reduce time to impact, and accelerate the translation of effective therapies into routine care.</p>\",\"PeriodicalId\":19778,\"journal\":{\"name\":\"Pharmaceutical Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2025-08-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmaceutical Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s40290-025-00581-y\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40290-025-00581-y","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Embedding Implementation Science in Clinical Trials: A Framework for Academic-Life Science Partnerships.
Implementation science offers a systematic approach to bridging the gap between research and clinical practice by promoting the adoption, scale-up, and sustainment of evidence-based therapies. Historically, academic implementation science efforts in the USA have focused on later-stage post-market research through government-funded initiatives, leaving untapped opportunities to engage more proactively with life science partners, such as pharmaceutical sponsors, earlier in the development process. Limited integration with life science partners, especially during early-phase clinical trials, represents a missed opportunity to address implementation challenges that affect real-world uptake proactively. The objective of this current opinion is to explore how implementation scientists can more effectively position their expertise to support the development, evaluation, and delivery of new therapies throughout the entire clinical trial lifecycle with life science partners. This article proposes a conceptual framework for collaboration between implementation scientists and life science partners, emphasizing how early integration can help identify healthcare system constraints, clinician adoption barriers, and patient acceptability issues, factors that often shape a therapy's downstream impact. Even before efficacy or regulatory certainty is established, implementation science can strengthen trial design, inform site and stakeholder selection, and enhance the interpretability and readiness of findings for real-world uptake. By aligning implementation methodologies with the strategic priorities of pharmaceutical sponsors, academic researchers can provide structured actionable insights that increase the likelihood of clinical and commercial success. Stronger partnerships established earlier in the development process may improve return on investment, reduce time to impact, and accelerate the translation of effective therapies into routine care.
期刊介绍:
Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.