W 08: Increasing the Efficiency of Investigator-Initiated Research in China
Sr. Study and Publication Manager, Medical Strategy and Operations Team
Pfizer Investment Co., Ltd China
To understand the globally integrated operational process & tools for IIR management that achieve the maximal effectiveness, compliance and deliverables, and gain an understanding of the IIR process in China and its unique challenges.
The globally standard policy and process management of IIR in Pfizer was elucidated, and the overall data and study management on China IIR were summarized. Co-authors include: Qing Gu, Sherry, Zhang, Jiayi Yan, Ning Shao, Chengming Gu, Alexander Kostek.
IIR is a type of Pfizer non-sponsored study, which enables investigators around the world to have the opportunity to design and conduct their study, foster innovation in medical research, and provide more valuable data to better understand drug development and disease therapy. All IIR in Pfizer must adhere to Global Standard Operating Procedure (GSOP) and Work Instruction (WI). The unique Integrated System for Pfizer Investigator Initiated Research (INSPIIRE) is utilized throughout the entire study process from submission to close. The audits make sure IIR are aligned with SOP, WI, local regulation and compliance.
In the past 10 years, there have been nearly 400 IIR studies submitted and conducted by investigators in China, including about 240 standard IIR and 150 more CG in various therapeutic areas: cardiovascular, anti-infectives, oncology, inflammation, urology, etc. Among them, 84% are in clinical research and 16% are in pre-clinical research. Of the clinical research, 61% is interventional study and 39% is non-interventional study. The grant review committee conducts a meeting monthly by therapeutic area. The study status and issues are reported to all stakeholders monthly. For each issue, the IIR team and medical advisor communicate with investigators and follow up to make sure it aligns with protocol and contract. Up to now, over 100 IIR studies in China have published the results in peer reviewed medical journal or conferences, which is a good measure of the study quality and shows that the studies provide valuable data which have impact around the world. Furthermore, to ensure better alignment with SOP and WIs, the monthly quality control by sampling is conducted and the issues are resolved promptly. We credit this for our good 2015 audit results in China IIR.
Highly efficient IIR management is based on the globally integrated SOP and tools, good communication internally and externally, and a good quality control process.