About 90% of Clinical Data Used for FDA Approval is From Non-US Sites
(Thursday, November 12, 2020]​
While it is well known that FDA accepts clinical trial data from anywhere so long as it meets certain quality standards, the full extent of the impact of this policy comes out in a report released by FDA this week. According to the report, almost 90% of the clinical data that was used for approval of all drugs and biologics in the last 5 years (2015-2019) came from multi-national clinical trials, and more than 5% approvals were based exclusively on non-US data. Only about 10% of the approvals were based on data exclusively from clinical sites based in the US. About 65% of all clinical trials participants were located outside the US. However, to be fair, while the US alone contributed 35% of the study participants, no other country in the world contributed more than 4% of the study participants, individually. Poland, Germany and Russia were the only three countries that contributed about 4% each of the study participants in clinical trials used for US approval. Within the US, California had the highest number of clinical trial participants, followed by Florida and Texas. For reasons not-explained in the reports, the non-US participation sharply dropped by almost 50% in the year 2015-2016, and has stayed low since then, while the participation of US-based volunteers has stayed steady. About 76% of the clinical trial participants were White, in proportion to their ratio in the overall population, followed by Asian participants at 11%, Blacks at 7% and others at 5%. Both male and female participants were included at almost similar rates. The largest number of trial participants and, by correlation, the largest clinical trials were those testing cardiovascular products, followed by endocrinology and metabolism, and then cancer indications, which also included higher proportions of non-US participants. Ophthalmology, gastroenterology, psychiatry, and dermatology trials involved higher proportions of US participants. This report confirms several widely held assumptions but also provides interesting high-level insight into diversity of clinical trial participation and FDA acceptance of clinical trial data.