Globalization of clinical trials: Variation in estimated regional costs of pivotal trials,2015

Abstract

Background/Aims

Despite the increasing globalization of clinical trials, little is known regarding how the trial site costs vary around the world. We quantified the geographical distribution and regional cost differences for the clinical trials that established the benefits for new therapeutic drugs approved by the US Food and Drug Administration in 2015 and 2016.

Methods

We included all pivotal clinical trials for 59 new molecular entities approved by the US Food and Drug Administration in 2015 and 2016 that included at least one site in North America. We derived cost estimates from IQVIA’s CostPro, a global clinical trial cost-estimating tool used by pharmaceutical sponsors. We assessed the patient and site allocation of these trials across eight geographic regions. To quantify the region-specific cost differences, we conducted a within-trial comparison by expressing the estimated regional costs associated with the sites in each global region as a percent of the same costs in North America. We also estimated the percentage breakdown of regional cost components (pass-through, site management, regulatory, and study conduct costs) for each trial and for all endpoints reported the median and interquartile range.

Results

Overall, 127 pivotal clinical trials enrolled 91,415 patients from 13,264 sites. Most patients (60.3%) and sites (57.3%) were outside North America. A median of 66% of the total estimated trial costs (interquartile range: 60%–72%) were spent on regional tasks, with the largest share (53.3%) going directly to trial sites and the remainder going to other regional trial management tasks. Differences were greatest in four lower cost regions: Africa, with an estimated regional cost per site of 49% of North America (interquartile range: 44%–56%), Central Europe 50% (interquartile range: 41%–63%), Middle East 53% (interquartile range: 42%–64%) and Latin America 59% (interquartile range: 50%–70%). Overall, 90 (71%) of the 127 pivotal trials had a total of 3160 sites in these lower cost regions. In contrast, savings were more limited in Western Europe, Oceania, and Asia, where estimated regional costs were 78% of North America (interquartile range: 67%–89%). One-quarter of the trials with sites in Asia and Oceana did not achieve cost savings in those regions relative to North America.

Conclusion

Among this sample of pivotal trials for recently approved US Food and Drug Administration products, most patients and sites enrolled were outside of North America, with selection of regional sites having a significant impact on total trial costs.

Keywords

Clinical trials cost savings globalization of clinical trials

Get full access to this article

View all access options for this article.

References

George

Selvarajan

et al . Globalization of clinical trials—where are we heading. Curr Clin Pharmacol 2013; 8(2): 115–123.

Jeong

Sohn

Kim

et al . Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013. Trials 2017; 18(1): 288.

Rowland

Clinical trials seen shifting overseas. Int J Health Serv 2004; 34(3): 555–556.

Shenoy

Multi-regional clinical trials and global drug development. Perspect Clin Res 2016; 7(2): 62–67.

London

Ethical oversight of public health research: can rules and IRBs make a difference in developing countries. Am J Public Health 2002; 92(7): 1079–1084.

Glickman

McHutchison

Peterson

et al . Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009; 360: 816–823.

Drug companies cut costs with foreign clinical trials. The New York Times, https://www.nytimes.com/2005/02/24/business/drug-companies-cut-costs-with-foreign-clinical-trials.html (2005, accessed 5 November 2018).

Garnier

J-P.

Rebuilding the R&D engine in big pharma. Harvard Business Review, https://hbr.org/2008/05/rebuilding-the-rd-engine-in-big-pharma (2008, accessed 5 November 2018).

According to cutting edge information research, Clinical Trials in India 44% less expensive than US trials, https://www.clinicalleader.com/doc/clinical-trials-in-india-less-expensive-than-0001 (2008, accessed 5 November 2018).

10.

Moore

Zhang

Anderson

et al . Estimated costs of pivotal trials for novel therapeutic agents approved by the U.S. Food and Drug Administration, 2015–2016. JAMA Intern Med 2018; 178(11): 1451–1457.

11.

U.S. Food and Drug Administration Center for Drug Evaluation and Research. Drug innovation—novel drug approvals for 2015, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm (accessed 6 November 2018).

12.

U.S. Food and Drug Administration Center for Drug Evaluation and Research. Drug innovation—novel drugs summary 2016, https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm534863 (2017, accessed 6 November 2018).

13.

U.S. Food and Drug Administration. Drugs@FDA: FDA approved drug products, https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 7 November 2018).

14.

ClinicalTrials.gov , https://clinicaltrials.gov/ (accessed 7 November 2018).

15.

IQVIA. Clinical trial optimization solutions, https://www.iqvia.com/solutions/technologies/clinical-trial-design-and-planning-suite/clinical-trial-optimization-solutions (accessed 7 November 2018).

Globalization of clinical trials: Variation in estimated regional costs of pivotal trials,2015–2016