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

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.

Development in the number of clinical trial applications in Western Europe from 2007 to 2015: retrospective study of data from national competent authorities

“…The remaining study did not address this question but found that more than a quarter of clinical trials registered in ClinicalTrials.gov recruit participants in non-high-income countries. 25 Other studies have also supported the hypothesis of a global shift. One study found that the number of active FDA-regulated investigators based outside the USA grew by 15% annually from 2002 to 2006, while the number of US-based FDA-regulated investigators declined.…”

Recrutamento de sujeitos em ensaios clínicos multicêntricos internacionais financiados pela indústria

“…Os artigos encontrados sobre o recrutamento de sujeitos de pesquisa em ensaios Mifi apresentam alguns números próximos dos obtidos, especialmente em relação ao custo por sujeito incluído nos ensaios (Berndt;Cockburn, 2014). Porém, outros trabalhos apontam número um pouco distinto, principalmente em relação ao número de sujeitos recrutados nos âmbitos nacional e local (Murthy;Mandl;Bourgeois, 2015). Muitos fatores podem contribuir para a variação das medidas, mas a diversidade de fontes de dados pode determinar essa variação.…”

Participants’ awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey

“…In the last 10 years, clinical trial registry in low- and low-middle income countries has increased around 260% [4, 5]. Currently, one in four industry-sponsored research trials (ISRT) include participants outside of high-income countries [6, 7]. Furthermore, clinical research protocols conducted in developing countries frequently have a proportional major participation in recruitment than developed countries [2, 6].…”

“…Currently, one in four industry-sponsored research trials (ISRT) include participants outside of high-income countries [6, 7]. Furthermore, clinical research protocols conducted in developing countries frequently have a proportional major participation in recruitment than developed countries [2, 6]. There are many reasons to explain the progressive growth of ISRT in developing countries: a significantly lower cost for execution, the growth of the pharmaceutical market in some of these regions, and the large populations interested in protocol participation as an alternative for their health care.…”