An Evaluation of Global Indicators as Surrogates for Clinical Research Capacity in the US, Poland, and Vietnam

Abstract

In the United States (US), the process for developing a new drug is a costly and lengthy endeavor. Study stakeholders would benefit from a novel methodology for identifying clinical trial site locations as a means to make the drug development process more expedient and more cost-effective. The aim of this study was to determine whether publicly available global indicator data could be used to evaluate the suitability of different countries for conducting human subject clinical trials. A set of nine dimensions was identified, representing important factors for conducting clinical trials, such as ethical oversight, human subject protections, and access to quality healthcare within a given country. Indicator data sets, from publicly available sources such as the World Health Organization, the World Bank, and the World Justice Project, were selected to align with each dimension. Novel indicators were created where alignment with existing, publicly available data was not possible. Publicly available indicator data aligned with four dimensions of clinical trial infrastructure (Dimension 1, Dimension 5, Dimension 6, and Dimension 7) across 85 countries. These dimensions were also shown to correlate with the Human Development Index, a measure of human development based on life expectancy, years of schooling, and gross national income. A fifth dimension (Dimension 3) used clinical trial registry data and global burden of disease data to create a novel indicator related to research focus on health needs/priorities. While the model developed for this study was too premature to fully comprehend the potential of using indicators derived from publicly available data to assess clinical research capacity, this study suggests that using these metrics could greatly aid in the decision-making process for clinical trial design. These methods could enable the identification of trial site locations far earlier than traditional methods, resulting in faster study startup, recruitment, and completion in regions with far lower study-related costs than the US or other developed nations – ultimately resulting in lower costs throughout the drug development process.