By Roger Tell, M.D., Ph.D.
In recent years, global clinical trials have become standard, and for a good reason. In broad terms, expanding clinical trials across the world gives the investigational drug better opportunity to demonstrate its true impact.
Global clinical trials offer key advantages to patients and industry; however, smaller companies may be hesitant to partake, wondering if the inevitable challenges outweigh the benefits. Companies with limited resources may struggle to handle relationships among necessary external contacts, including CROs, investigators, and regulatory agencies. Throughout my career as an oncologist and in my role as the chief medical officer at Isofol Medical, a Swedish biotech company running a global Phase 3 clinical trial in advanced colorectal cancer, I’ve become familiar with several best practices to overcome many of these issues.