Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|February 5, 2018
The US and the Location of Clinical Sites
Author(s)Harold E. Glass, PhD, David Akirtava, PhD
More recent ClinicalTrials.gov data indicate that the United States remains the central location for clinical trial activity.
Advertisement
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%
Advertisement
Related to this article
Clinical trials capture data faster than ever, but the real bottleneck is the distance between data capture and a decision teams can trust.
In today’s ACT Brief, we examine why the future of AI in trials is a trusted orchestration system rather than a single model, how coordinators rate eSource-enabled workflows, and what a bipartisan bill proposes for reusable trial networks.
The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.
Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.
In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Where the Industry Is Headed as Clinical, Operational, and Real-World Data Connect
2
Where AI Governance in Clinical Development Falls Short
3
ACT Brief: Orchestrated AI Clinical Environments, eSource Coordinator Satisfaction, and Faster Clinical Trials Act
4
Clinical Trials Do Not Have a Data Problem, They Have a Decision-Readiness Problem
5