Arise in the number of developmental compounds, greater complexity in clinical trials, and an expansion of clinical-trial
sites globally are raising the bar in managing the clinical-trial-material (CTM) supply chain. Pharmaceutical companies and
their suppliers must align product supply with demand at multiple sites in several countries with fluctuating patient-enrollment
rates and greater complexity in dosing regimes while maintaining product quality and supply continuity. As a result, strategies
that use best practices in drug modeling, simulation, packaging, labeling, logistics, and supply-chain management are of increasing
ILLUSTRATION BY SELVAKUMAR VEERAPUTHIRAN. IMAGES : IMAGE SOURCE/GETTY IMAGES
Greater complexity and global reach
Since 2000, the number of developmental drug compounds has increased as has the complexity of clinical trials. Approximately
2040 compounds were under development in 2001, and this number increased nearly 50% in 2010 to 3050 compounds, according to
a recent report by the Pharmaceutical Research and Manufacturers of America (1). Between 2000–2003 and 2004–2007, the median
number of procedures per clinical trial increased by 49% while the total work burden per protocol grew by 54% (1, 2). As
complexity increases, so do eligibility criteria for volunteers, which lead to lower volunteer recruitment and retention rates.
The average number of eligibility criteria for volunteers has increased by 58%, and volunteer enrollment and retention rates
have declined by 21% and 30%, respectively (1, 2).
Concurrently, the number of clinical-trial sites outside the United States has increased. Eighty percent of FDA-approved marketing
applications for drugs and biologics contained data from foreign clinical trials in fiscal year 2008, according to a 2010
report by the Office of Inspector General of the US Department of Health and Human Services (HHS) (3). More than half of clinical-trial
subjects and sites were located outside the US (see Table I).
Table I: Number and percentage of foreign subjects and sites from clinical trials supporting drug and biologic marketing
applications approved by FDA in fiscal year 2008.
Western Europe accounted for most foreign clinical-trial subjects and sites (approximately 60%). Central and South America
had the highest average number of subjects per site, accounted for 26% of all subjects enrolled at foreign trial sites, and
7% of foreign sites. According to estimates cited by the HHS report, between 40% and 65% of clinical trials investigating
FDA-regulated products are conducted outside of the US. A recent analysis of http://ClinicalTrials.gov/, a National Institutes of Health registry and results database of federally and privately supported clinical trials, examined
recruitment in industry-sponsored Phase III clinical trials and found that as of November 2007, one-third of the clinical
trials of the 20 largest US-based pharmaceutical companies were conducted at foreign sites (3, 4).