临床试验透明度和数据共享政策
本政策明确了百特在临床试验注册方面的立场, 数据披露, 百特赞助临床研究的发表和数据共享. 本着透明的精神, 百特在定义足球外围最靠谱的网站的披露承诺时超越了法律的要求. We believe that making clinical trial data publicly available is aligned with our mission to Save and Sustain Lives and promotes (1) Good Corporate Citizenship, (2)循证医学和(3)改善投资者关系.
临床试验注册
Baxter will register and disclose information for company sponsored human clinical research on 临床试验.政府 and/or other websites in compliance with industry standards and applicable local regulations. 临床试验初始注册将包括数据共享计划.
业绩披露
百特将发布结果(e.g. clinical study report synopses) of its completed applicable human clinical research on any device or product approved or cleared for marketing within one year of study completion, 或在监管部门批准或批准后30天内, 适当的. 临床试验将予以披露.政府 and/or other websites in compliance with industry standards and applicable local regulations. 百特也可以选择发布其他人类主题研究的结果.
公布资料
百特致力于准确、平衡和及时地发表其研究成果. Baxter commits to submit for publication to peer-reviewed venues the results of phase 3/pivotal human clinical trials, as well as all other research for which results are considered 科学ally or medically important, 不管研究结果如何. 所有提交出版的手稿将包含一份数据共享声明, 与国际医学期刊编辑委员会一致.
百特遵循ICMJE概述的作者标准1. Contributors who do not fulfill all authorship criteria are acknowledged for their specific role in the project.
作者协议:在出版之前, Baxter and external author(s) confirm in an authorship agreement to adhere to the Good Publication Practices guidelines2, and the ICMJE guidelines and define each other's responsibilities toward the 发展 of the publication, 由科学编辑委员会定义3. Baxter does not pay any fees or honoraria for authorship of peer-reviewed articles or presentations. 只有作者所支付的合理费用.g. travel expenses, journal charges) are reimbursed and disclosed as required by applicable laws.
Medical Writing: Medical writers can provide valuable assistance in timely communication of clinical study results, 但这样的努力可能并不能保证作者的身份. 医学作家协助起草或修改手稿, 他们的贡献将得到承认和披露. 如果他们为此工作得到补偿，资金来源也将被公开.
数据获取/分析:确保临床研究结果的独立解释, Baxter grants all external authors access to anonymized patient-level data and relevant materials as needed by them to fulfill their role and obligations as authors under the ICMJE criteria. Baxter will provide a study's aggregated data to external study investigators by a mutually agreeable method and format, 如果请求. Results from individual sites within a multi-center study will not be published separately from the overall results, 也不会在完整的研究结果发表之前, 未经双方同意. 配偶4 随机对照试验结果的报告将遵循指南.
根据杂志的要求, 百特将提供研究方案, 预先制定的分析方案, 以及匿名的患者数据，用于重新分析/验证.
Baxter review: Authors retain editorial control of the publication's content and accept full responsibility for the publication by approval of the final version prior to submission for publication. 如果没有体育外围网站的作者, then Baxter may review the publication for protection of intellectual property and trade secrets, 和医疗, 科学, 以及统计准确性. Safeguarding intellectual property rights such as patent filing may require delaying the publication for a reasonable period.
商业(销售和市场)不参与计划, 发展, 或出版物的审查.
数据共享
Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and 科学 researchers in the interest of advancing public health. 像这样, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, 协议和SAP)，在收到合法的研究请求时. Research requests will be reviewed by qualified medical and 科学 experts within the company. 前提是百特同意公布临床数据用于研究, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
Sharing Results with Study Participants: Baxter will make available a lay summary of the results to individuals who volunteer in a clinical trial and as required by law and/or regulation.
引用:
1 ICMJE行为建议, 报告, 编辑, 在医学期刊上发表学术论文. 国际医学期刊编辑委员会， http://www.icmje.org/recommendations
2 Good Publication Practice for communicating company sponsored medical research: the GPP2 guidelines. 伯爵C. 等. BMJ 2009; 339: b4330
3 科学期刊出版物的完整性，2020年更新. 科学编辑委员会. http://www.councilscienceeditors.org/resource-library/editorial-policies/white-paper-on-publication-ethics/
4 Schulz KF, Altman DG, Moher D,; 配偶 Group. 配偶 2010声明:报告平行组随机试验的更新指南. 英国医学杂志2010年3月23日;340 " c332