Getz Kenneth A, Lamberti Mary Jo, Kaitin Kenneth I
Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts..
Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.
Clin Ther. 2014 Oct 1;36(10):1349-55. doi: 10.1016/j.clinthera.2014.09.008. Epub 2014 Oct 23.
Articles in peer-reviewed journals and the trade press presuppose that strategic outsourcing relationships have been formed to replace preexisting collaborative approaches with contract research organizations. They do not consider that large, fragmented pharmaceutical and biotechnology companies may be supporting competing and conflicting relationship models simultaneously. A recent Tufts Center for the Study of Drug Development study quantifies actual strategic outsourcing practices among drug development companies and sheds new light on why these relationships may be failing.
Tufts Center for the Study of Drug Development conducted an in-depth assessment of 43 Phase II and III clinical studies completed since 2012 to examine the outsourcing relationships used by 9 major pharmaceutical and biotechnology companies to support key functional areas. Descriptive statistics were assessed and t tests were performed to characterize outsourcing practices by function and to determine differences in study performance between transactional and strategic outsourcing relationships.
The results indicate that sponsor companies are using a variety of outsourcing relationship models to support their studies, mixing and matching the use of internal staff, and using traditional transactional and strategic outsourcing relationships simultaneously. Specifically, despite the fact that each sponsor company had entered into several strategic outsourcing relationships, in no instance did a single contract research organization manage all functional areas supporting an individual Phase II or III study. In addition, sponsor companies vary the types of outsourcing relationship models that they use on a study-by-study basis.
The inability of pharmaceutical and biotechnology companies to consistently embrace and coordinate sourcing strategies is creating internal friction and inefficiency. As a result, the expected impact of strategic outsourcing relationships on drug development performance, quality, and cost remains elusive.
同行评审期刊和行业媒体上的文章假定，战略外包关系的形成是为了用合同研究组织取代先前的合作方式。它们没有考虑到大型、分散的制药和生物技术公司可能同时支持相互竞争和冲突的关系模式。塔夫茨药物开发研究中心最近的一项研究对药物开发公司的实际战略外包实践进行了量化，并揭示了这些关系可能失败的原因。
塔夫茨药物开发研究中心对自2012年以来完成的43项II期和III期临床研究进行了深入评估，以考察9家主要制药和生物技术公司用于支持关键功能领域的外包关系。评估了描述性统计数据，并进行了t检验，以按功能描述外包实践，并确定交易性和战略性外包关系之间的研究绩效差异。
结果表明，申办公司正在使用多种外包关系模式来支持其研究，混合搭配内部员工的使用，并同时使用传统的交易性和战略性外包关系。具体而言，尽管每家申办公司都建立了多个战略外包关系，但没有一个合同研究组织负责管理支持单个II期或III期研究的所有功能领域。此外，申办公司在每项研究中使用的外包关系模式类型各不相同。
制药和生物技术公司无法始终如一地接受和协调采购战略，正在造成内部摩擦和低效率。因此，战略外包关系对药物开发绩效、质量和成本的预期影响仍然难以捉摸。
