Common Protocol (CP)
Overview
The common protocol (CP) approach involves creating a standardized study protocol that defines clear objectives, consistent definitions, procedures, and data collection methods. This approach addresses variations in healthcare systems, data quality, and regulatory requirements across countries by establishing uniform guidelines. It enables the pooling of data from diverse populations, leading to robust evidence for regulatory decisions, policy development, and clinical practice improvements. While conducting the CP approach is straightforward, success relies on identifying potential data partners and building effective collaborations.
Our team has been actively engaged in the international pharmacoepidemiology community for many years, establishing strong connections with partners from various countries. We have extensive experience coordinating multi-national studies using different types of databases, such as claims data and electronic health records, and different study designs, such as cohort studies, case-control studies, and self-control case series. This approach has led to numerous published multinational studies involving countries such as South Korea, Hong Kong, Japan, Australia, Denmark, the United Kingdom, the United States, Norway, and more.
Selected publications:
Shen CY, Au PC, Baek YH, et al. Comparative Treatment Persistence with Bone-Targeting Agents Among Asian Patients with Bone Metastases from Solid Tumors: A Multinational Retrospective Cohort Study. BioDrugs. 2022;36(3):381-392. doi:10.1007/s40259-022-00528-8
