Current practice and perspectives in CRO oversight for Biostatistics & Data Management services – survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa)

摘要

Outsourcing of activities is common and increasing in the pharmaceutical industry, not only for clinical trial conduct, or other trial related aspects but also for biostatistics and data management. This raises the question of whether and how sponsors retain the capability to select and to control the CRO(s) involved and what biometrical expertise still has to be present in the sponsor company to ensure adequate oversight. Not only in the case of partial outsourcing but especially in the case of complete outsourcing sponsors have to find the right balance between a complete “hands off” approach and a resource intensive in-house shadowing of activities to fulfil the requirements. In order to answer these questions, a survey was conducted among the German vfa member companies. This article discusses the specific oversight topics for the outsourcing of data management and biostatistics services, e.g. requirements for data quality, coding, and statistical analyses. This study shows that the majority of the companies use the same CRO for biometrical services as for rest of study services and that there is a preferred provider for these services in 65% of the companies. There are established, specific requirements for the main deliverables of biometrical services: For coding and data standards these are predominantly industry standards (MedDRA, CDISC). For statistic outputs and data quality mainly sponsor standards are used. The adherence to the requirements is mainly checked via spot-checks, and standardized checklists are mainly used for checking data standards. Generally, in all companies participating in the survey, there is an awareness of the necessity of biometrical oversight. Although not necessarily perfect yet, all companies took measures to ensure good biometrical oversight and there is a common understanding, that it is not an option to resign from biometrical oversight.