Tufts Center for the Study of Drug Development (Tufts CSDD), 75 Kneeland Street, Floor 11, Boston, MA, 2741, USA.
Clinical Performance Partners, Atlanta, GA, USA.
Ther Innov Regul Sci. 2020 Jan;54(1):158-166. doi: 10.1007/s43441-019-00040-2. Epub 2020 Jan 6.
The Tufts Center for the Study of Drug Development conducted a study updating benchmarks on outsourcing model adoption and assessing oversight practices and experience.
An online survey examining organizational use of clinical development outsourcing was distributed between February and April 2018. Responses from a total of 88 individuals were included in the final analysis.
More than half of individuals responding reported using 3 or more models simultaneously, mixing and matching approaches to meet individual project needs. Outsourcing practices among small, medium, and large sponsor companies remain inconsistent and deliver mixed levels of satisfaction and performance. Full-service models are the most commonly used. Biopharmaceutical companies report that the primary purpose of their oversight mechanisms is to minimize risks and regulatory missteps. Oversight mechanisms are generally supported by middle management personnel focusing on more reactive and tactical issues. Executive-level involvement in outsourcing oversight is minimal and highly variable.
Several opportunities to improve oversight practices were identified in the study, including increasing executive-level involvement and leveraging technologies to monitor performance, enhance communication, and expand collaboration capabilities.
塔夫茨药物开发研究中心进行了一项研究，更新了关于外包模式采用的基准，并评估了监督实践和经验。
2018 年 2 月至 4 月期间，我们进行了一项在线调查，调查了组织对临床开发外包的使用情况。共有 88 人参与了最终分析。
超过一半的受访者报告称同时使用了 3 种或更多模型，混合和匹配方法以满足个别项目的需求。小型、中型和大型赞助商公司的外包实践仍然不一致，提供的满意度和绩效水平参差不齐。全方位服务模式是最常用的。生物制药公司报告称，其监督机制的主要目的是最大限度地降低风险和监管失误。监督机制通常由专注于更具反应性和战术性问题的中层管理人员提供支持。高管层对外包监督的参与度很低，且高度可变。
研究中发现了一些改进监督实践的机会，包括增加高管层的参与度，利用技术来监控绩效、增强沟通和扩大协作能力。
