The US and the Location of Clinical Sites

For a number of years there has been discussion about the relative levels of clinical trial activity in the United States and Western Europe, on the one hand, and in the emerging countries, on the other. This seems to be one of the more popular topics at drug development professional conferences. A previous column (Applied Clinical Trials Dec 5, 2016) with ClinicalTrials.gov data indicated that the absolute and relative amount of commercially sponsored clinical activity in North America and Europe remained unchanged between 2008 and 2013. More recent ClinicalTrials.gov data indicate that the United States remains the central location for clinical trial activity.

Clinical trials are conducted to gather patient data, the most critical element in the new drug approval process. But the placement of clinical trials is a function of a number of elements, not the least of which is a country’s market attractiveness. Through clinical trials a sponsor company learns more about how the new drug might be used by medical professionals in a particular country. Clinical trials gather information, but they also signal information to a market about a sponsor company’s longer term new drug launch priorities. On a cost per patient basis some of the newer geographies are frequently lower than more established areas like the United States and Europe. However, many companies have found that the costs of conducting clinical trials in these newer geographies to be sometimes higher than originally anticipated when all the site operational costs are taken into account. The United States despite the higher costs of investigator payments remains the most attractive market for new drugs.

Over time it has become clear that there is a reporting lag of about six months to a year in ClinicalTrials.gov, a lag which increases to about a year for ex-US data. Over time as additional data appear the 2015 and 2016 will most likely resemble the 2014 figures. Nonetheless, the current ClinicalTrials.gov data show no trend away from the United States as a place to locate clinical trial sites. Discussions about conducting clinical trials in new geographies should remain an important topic at professional meetings, particularly for the more exotic locations.   

Site Location

Total Sites in Industry Sponsored Phase 3 Studies

Percentage of Sites in the United States

2014

48,760

38%

2015

45,318

40%

2016

32,581

46%