Lawrence Colleen E, Bruce Virginia Nickie M, Salberg Libby D, Edwards Terri, Morales Casi, Palm Marisha, Bernard Gordon R
Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Office of Legal Contract Administration, Mayo Clinic, Rochester, MN, USA.
J Clin Transl Sci. 2023 Sep 6;7(1):e204. doi: 10.1017/cts.2023.622. eCollection 2023.
Contracting delays remain a challenge to the successful initiation of multisite clinical research in the US. The Clinical and Translational Science Awards (CTSA) Contracts Processing Study showed average contract negotiation duration of > 100 days for industry-sponsored or investigator-initiated contracts. Such delays create enormous costs to sponsors and to patients waiting to use new evidence-based treatments. With support from the National Institutes of Health's National Center for Advancing Translational Sciences, the Accelerated Clinical Trial Agreement (ACTA) was developed by 25 major academic institutions and medical centers engaged in clinical research in collaboration with the University-Industry Demonstration Partnership and with input from pharmaceutical companies. The ACTA also informed the development of subsequent agreements, including the Federal Demonstration Partnership Clinical Trial Subaward Agreement (FDP-CTSA); both ACTA and the FDP-CTSA are largely non-negotiable agreements that represent pre-negotiated compromises in contract terms agreed upon by industry and/or medical center stakeholders. When the involved parties agree to use the CTSA-developed and supported standard agreement templates as a starting point for negotiations, there can be significant time savings for trials. Use of the ACTA resulted in an average savings of 48 days and use of the FDP-CTSA saved an average of 57 days of negotiation duration.
合同签订延迟仍然是美国多中心临床研究成功启动面临的一项挑战。临床与转化科学奖（CTSA）合同处理研究表明，行业赞助或研究者发起的合同，平均合同谈判时长超过100天。此类延迟给赞助商以及等待使用基于新证据的治疗方法的患者带来了巨大成本。在美国国立卫生研究院国家转化科学推进中心的支持下，25家主要学术机构和从事临床研究的医学中心与大学-产业示范合作组织合作，并在制药公司的参与下，制定了加速临床试验协议（ACTA）。ACTA还为后续协议的制定提供了参考，包括联邦示范合作组织临床试验分授标协议（FDP-CTSA）；ACTA和FDP-CTSA在很大程度上都是不可协商的协议，代表了行业和/或医学中心利益相关者在合同条款上预先协商达成的妥协。当相关各方同意将CTSA制定并支持的标准协议模板作为谈判起点时，试验可大幅节省时间。使用ACTA平均节省了48天时间，使用FDP-CTSA平均节省了57天的谈判时长。
