No, I don’t have a crystal ball. Yesterday, I posted comments on the factors FDA can use to determine what foreign trial data it can use (extrapolate) to US populations and medical practice. Today, an article entitled “Ethical and Scientific Implications of the Globalization of Clinical Research” appears in the New England Journal of Medicine that raises concerns about the use of foreign patients. The title suggests a balance between science and ethics but the major topic is the authors’ concern is about the ethics.
Ethical concerns have largely been the reason why the FDA, despite having full authority to approve an NDA based solely on foreign data, have declined to do so. Very few, maybe a handful, NDAs have been approved based solely on foreign data. These rare exceptions to the US-only data are found in oncology, anti-infectives and certain bone disease – diseases that are almost impossible to study in the US because of prior or concomitant treatments.
The NEJM article has very good references to the discussions that regulatory bodies have had for many years on the ethics of conducting foreign trials. FDA seems comfortable with the current protections afforded by ICH and GCP guidances. The authors ask for further study and offer ‘solutions’ to issues that are already addressed.