Publication:

Navigating the global shift: prospects and challenges in the clinical research enterprise

In recent years, the conduct of clinical trials in developing countries has increased markedly, reflecting a broader shift of the clinical research enterprise toward non-traditional geographic regions. This expansion is driven by multiple factors including greater availability of research participants, decreased costs of conducting research and, in some cases, less restrictive regulatory environments. While these underlying forces present valuable opportunities to the clinical research enterprise system, they also introduce complex scientific, ethical, and regulatory challenges. Nevertheless, if the challenges are navigated prudently, the globalization of clinical research trials may hold considerable potential to accelerate the development of innovative medical therapies that could contribute meaningfully to addressing the global health needs.