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Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework. 将质量文化转化为临床研究行为：扩展临床开发质量框架。
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-05-01 Epub Date: 2024-02-07 DOI: 10.1007/s43441-023-00610-5
Michael Torok, Leslie Sam, Jennifer Hebert
{"title":"Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework.","authors":"Michael Torok, Leslie Sam, Jennifer Hebert","doi":"10.1007/s43441-023-00610-5","DOIUrl":"10.1007/s43441-023-00610-5","url":null,"abstract":"<p><p>The International Council on Harmonisation E8 Guidance Revision 1 (ICH E8(R1)) calls for creating a Culture of Quality that \"values and rewards critical thinking and open, proactive dialogue about what is critical to quality.\" Across the biopharma landscape, clinical sites, sponsors, and service providers are working to translate this far-reaching guideline into working practices. This manuscript deconstructs key elements that comprise the critical thinking and open, proactive Culture of Quality \"enablers.\" In addition, maturity models are provided so readers can visualize what a Culture of Quality looks like in their clinical research organization. These provide examples of high performing cultures of quality and useful tools for teams or organizations to measure and evolve their respective quality cultures.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043139/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139698393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials. 中央统计监控能否提高数据质量？对 159 项临床试验中 111 个研究点的分析。
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-05-01 Epub Date: 2024-02-09 DOI: 10.1007/s43441-024-00613-w
Sylviane de Viron, Laura Trotta, William Steijn, Steve Young, Marc Buyse
{"title":"Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials.","authors":"Sylviane de Viron, Laura Trotta, William Steijn, Steve Young, Marc Buyse","doi":"10.1007/s43441-024-00613-w","DOIUrl":"10.1007/s43441-024-00613-w","url":null,"abstract":"<p><strong>Background: </strong>Central monitoring aims at improving the quality of clinical research by pro-actively identifying risks and remediating emerging issues in the conduct of a clinical trial that may have an adverse impact on patient safety and/or the reliability of trial results. This paper, focusing on statistical data monitoring (SDM), is the second of a series that attempts to quantify the impact of central monitoring in clinical trials.</p><p><strong>Material and methods: </strong>Quality improvement was assessed in studies using SDM from a single large central monitoring platform. The analysis focused on a total of 1111 sites that were identified as at-risk by the SDM tests and for which the study teams conducted a follow-up investigation. These sites were taken from 159 studies conducted by 23 different clinical development organizations (including both sponsor companies and contract research organizations). Two quality improvement metrics were assessed for each selected site, one based on a site data inconsistency score (DIS, overall -log<sub>10</sub> P-value of the site compared with all other sites) and the other based on the observed metric value associated with each risk signal.</p><p><strong>Results: </strong>The SDM quality metrics showed improvement in 83% (95% CI, 80-85%) of the sites across therapeutic areas and study phases (primarily phases 2 and 3). In contrast, only 56% (95% CI, 41-70%) of sites showed improvement in 2 historical studies that did not use SDM during study conduct.</p><p><strong>Conclusion: </strong>The results of this analysis provide clear quantitative evidence supporting the hypothesis that the use of SDM in central monitoring is leading to improved quality in clinical trial conduct and associated data across participating sites.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043176/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139707968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations. 行业对 "获取联盟新活性物质工作共享倡议"（NASWSI）的看法和经验：调查结果和建议。
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-05-01 Epub Date: 2024-03-08 DOI: 10.1007/s43441-024-00624-7
Gaia Geraci, Robert Smith, Alison Hansford, Eric Johnsson, Helen Critchley, Lama Abi Khaled, Laura King, Michelle Cheng, Tanja Colin, Tse Siang Kang
{"title":"Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations.","authors":"Gaia Geraci, Robert Smith, Alison Hansford, Eric Johnsson, Helen Critchley, Lama Abi Khaled, Laura King, Michelle Cheng, Tanja Colin, Tse Siang Kang","doi":"10.1007/s43441-024-00624-7","DOIUrl":"10.1007/s43441-024-00624-7","url":null,"abstract":"<p><p>The Access Consortium New Active Substance Work-Sharing Initiative, or \"Access\" for simplicity, allows regulatory authorities (RAs) of the Access Consortium countries to jointly review applications for the registration of new active substances or for new indications. Using a survey developed by the pharmaceutical industry trade associations of the five Access Consortium countries-Australia, Canada, Singapore, Switzerland, and the United Kingdom (UK)-this study gathered insights into the perceptions and experiences of the Access pathway held by affiliates of pharmaceutical companies. Understanding industry perceptions of Access is important for the success of the initiative, as participation is voluntary. Findings indicate that affiliates who participated in Access had mostly positive experiences with this pathway; most affiliates were satisfied with their interactions with the Access RAs and appeared willing to continue to participate in the initiative. Affiliates' reasons for not having yet participated in Access included a lack of opportunity to do so and perceived barriers, such as the Access pathway being too complicated to manage. Recommendations to improve Access cover six key areas: ensure predictability, increase guidance and transparency, streamline processes, maintain flexibility, increase harmonization, and advance RA-industry cooperation. This study should facilitate informed discussions among relevant stakeholders on how to improve Access to maximize efficiencies, accelerate approvals, and improve patient access to innovative medicines.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140065922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy. 阿根廷、澳大利亚、巴西和意大利生物仿制药定价的跨国比较。
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-05-01 Epub Date: 2024-03-04 DOI: 10.1007/s43441-024-00623-8
Fernanda Lacerda da Silva Machado, Martín Cañás, Martín A Urtasun, Gustavo H Marín, Flavia Caixeta Albuquerque, Lisa Pont, Irma Convertino, Marco Bonaso, Marco Tuccori, Ursula Kirchmayer, Luciane Cruz Lopes
{"title":"A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy.","authors":"Fernanda Lacerda da Silva Machado, Martín Cañás, Martín A Urtasun, Gustavo H Marín, Flavia Caixeta Albuquerque, Lisa Pont, Irma Convertino, Marco Bonaso, Marco Tuccori, Ursula Kirchmayer, Luciane Cruz Lopes","doi":"10.1007/s43441-024-00623-8","DOIUrl":"10.1007/s43441-024-00623-8","url":null,"abstract":"<p><strong>Background: </strong>Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments.</p><p><strong>Objective: </strong>This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries.</p><p><strong>Method: </strong>This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage.</p><p><strong>Results: </strong>Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2).</p><p><strong>Conclusion: </strong>The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140022592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data. 存在缺失数据时胜率参数的不确定性。
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-05-01 Epub Date: 2024-03-26 DOI: 10.1007/s43441-024-00645-2
Heng Li, Wei-Chen Chen, Nelson Lu, Rong Tang, Yu Zhao
{"title":"The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data.","authors":"Heng Li, Wei-Chen Chen, Nelson Lu, Rong Tang, Yu Zhao","doi":"10.1007/s43441-024-00645-2","DOIUrl":"10.1007/s43441-024-00645-2","url":null,"abstract":"","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140294602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here? 在澳大利亚通过 Teletrials 实施分散临床试验：何去何从？
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-04-29 DOI: 10.1007/s43441-024-00658-x
Tanya Symons, Anne Woollett, John Zalcberg, Lisa Eckstein
{"title":"Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here?","authors":"Tanya Symons, Anne Woollett, John Zalcberg, Lisa Eckstein","doi":"10.1007/s43441-024-00658-x","DOIUrl":"https://doi.org/10.1007/s43441-024-00658-x","url":null,"abstract":"<p><p>Implementation of decentralized approaches can improve access to clinical trials. The Australian government has focused on a teletrial model, which resources and upskills health care organisations to enable collaboration in trials to extend to rural and remote areas. This commentary describes the Australian teletrial model, its context within the established DCT model, its value, and likely challenges moving forward.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape? 欧洲临床试验中的数字医疗技术（DHT），如何改善监管现状？
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-04-24 DOI: 10.1007/s43441-024-00657-y
H. Podhaisky
{"title":"Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?","authors":"H. Podhaisky","doi":"10.1007/s43441-024-00657-y","DOIUrl":"https://doi.org/10.1007/s43441-024-00657-y","url":null,"abstract":"","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140665275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology. 将日本纳入肿瘤学多区域一期临床试验的相关因素。
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-04-23 DOI: 10.1007/s43441-024-00655-0
Akio Maki, M. Narukawa
{"title":"Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology.","authors":"Akio Maki, M. Narukawa","doi":"10.1007/s43441-024-00655-0","DOIUrl":"https://doi.org/10.1007/s43441-024-00655-0","url":null,"abstract":"","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140670220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics. 释放潜能：儿科主协议系统回顾》。
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-04-23 DOI: 10.1007/s43441-024-00656-z
Yimei Li, Robert Nelson, Rima Izem, K. Broglio, R. Mundayat, Margaret Gamalo, Yansong Wen, Haitao Pan, Hengrui Sun, Jingjing Ye
{"title":"Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics.","authors":"Yimei Li, Robert Nelson, Rima Izem, K. Broglio, R. Mundayat, Margaret Gamalo, Yansong Wen, Haitao Pan, Hengrui Sun, Jingjing Ye","doi":"10.1007/s43441-024-00656-z","DOIUrl":"https://doi.org/10.1007/s43441-024-00656-z","url":null,"abstract":"","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140670280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry. 评估全球药品和医疗器械行业结构化效益-风险评估现状的调查。
IF 1.5 4区 医学
Therapeutic innovation & regulatory science Pub Date : 2024-04-22 DOI: 10.1007/s43441-024-00650-5
Martin Gebel, Cheryl Renz, Lisa Rodriguez, Arianna Simonetti, Hong Yang, Brian Edwards, James Matthew Higginson, Nicola Charpentier, Michael Colopy
{"title":"A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry.","authors":"Martin Gebel, Cheryl Renz, Lisa Rodriguez, Arianna Simonetti, Hong Yang, Brian Edwards, James Matthew Higginson, Nicola Charpentier, Michael Colopy","doi":"10.1007/s43441-024-00650-5","DOIUrl":"https://doi.org/10.1007/s43441-024-00650-5","url":null,"abstract":"","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140677254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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