Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013.

Srinivas Murthy,Florence T Bourgeois,Kenneth D Mandl

doi:10.1186/s12961-015-0019-6

Abstract

BackgroundIndustry-sponsored clinical trials, in the past performed almost exclusively in more developed countries, now often recruit participants globally. However, recruitment from outside high-income countries may not represent the ultimate target population for the intervention. Clinical trial registries provide an opportunity to quantify and examine the type of clinical research performed in various geographic regions. We sought to characterize industry-sponsored randomized controlled trials conducted in high-income countries and to compare these trials to those performed outside high-income countries.MethodsClinical trial data on all industry-funded randomized controlled trials conducted between 2006 and 2014 were obtained from the registry ClinicalTrials.gov. Trials were classified according to their study sites as conducted in high or non-high income countries, and data on trial characteristics were collected.ResultsOf 22,511 relevant trials, a total of 6,085 (27.0 %) trials included study sites outside a high-income country, and 2,045 (9.1 %) were conducted exclusively outside high-income countries. Of country groups, Central Europe had the greatest number of trials (3,127), followed by Eastern Europe (2,075). The percentage of trials with study sites outside high-income countries remained relatively constant over the study period. Studies with sites outside high-income countries tended to recruit more participants (median enrolled participants 265 vs. 71, P <0.001), to be longer (median study duration 20 vs. 13 months, P <0.05), and to study more advanced phase interventions (Phase 3 or 4 trial 58 % vs. 33 %, P <0.001).ConclusionsMore than a quarter of industry-sponsored trials include participants from outside high-income countries and this rate remained stable over the 7-year study period. Trials conducted outside high-income countries tend to be larger, have a longer duration, and study later phase interventions compared to studies performed exclusively in high-income countries.Electronic supplementary materialThe online version of this article (doi:10.1186/s12961-015-0019-6) contains supplementary material, which is available to authorized users.

Highlights

Industry-sponsored clinical trials, in the past performed almost exclusively in more developed countries, often recruit participants globally
Industry-sponsored clinical research has traditionally been performed in high-income countries, given the established research infrastructure and the geographic location of major pharmaceutical companies
Our aim was to describe current patterns regarding the globalization of industry-sponsored clinical trials, including the number of trials performed in different geographic regions and the collaboration between these regions

Summary

Introduction

Industry-sponsored clinical trials, in the past performed almost exclusively in more developed countries, often recruit participants globally. Clinical trial registries provide an opportunity to quantify and examine the type of clinical research performed in various geographic regions. Industry-sponsored clinical research has traditionally been performed in high-income countries, given the established research infrastructure and the geographic location of major pharmaceutical companies. Globalization has led to the extension of industry-sponsored clinical research outside higher income regions [1,2,3], with approximately. The global burden of disease is predominantly centred outside higher income regions, potentially accelerating trial recruitment for the large sample sizes required [6,7,8]. Recognition of the growing market share of less-developed regions may provide added incentive to have drugs tested and approved in these countries [11]

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