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

Murthy S, Mandl KD, Bourgeois FT - Health Res Policy Syst (2015)

Bottom Line: Industry-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.

View Article: PubMed Central - PubMed

Affiliation: Department of Pediatrics, University of British Columbia, 4500 Oak Street, V6H 3V4, Vancouver, BC, Canada. Srinivas.murthy@cw.bc.ca.

ABSTRACT

Background: Industry-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.

Methods: Clinical 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.

Results: Of 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).

Conclusions: More 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.

No MeSH data available.


Global map of regions and major geographic groups
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Fig1: Global map of regions and major geographic groups

Mentions: Countries were geographically classified according to the categorization used in the Global Burden of Disease project which classifies countries into 21 regions and these regions into five major geographic groups (Fig. 1), available at http://ghdx.healthdata.org/country_profiles [23]. The major groups are Asia, Africa/Middle East, Europe (non-Western), Americas, and High-income regions. The regions classified as High-income are High-income Asia Pacific, High-income North America, Australasia, and Western Europe. We considered all countries falling into one of these regions as high-income and all others as non-high income.Fig. 1


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

Murthy S, Mandl KD, Bourgeois FT - Health Res Policy Syst (2015)

Global map of regions and major geographic groups
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4465475&req=5

Fig1: Global map of regions and major geographic groups
Mentions: Countries were geographically classified according to the categorization used in the Global Burden of Disease project which classifies countries into 21 regions and these regions into five major geographic groups (Fig. 1), available at http://ghdx.healthdata.org/country_profiles [23]. The major groups are Asia, Africa/Middle East, Europe (non-Western), Americas, and High-income regions. The regions classified as High-income are High-income Asia Pacific, High-income North America, Australasia, and Western Europe. We considered all countries falling into one of these regions as high-income and all others as non-high income.Fig. 1

Bottom Line: Industry-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.

View Article: PubMed Central - PubMed

Affiliation: Department of Pediatrics, University of British Columbia, 4500 Oak Street, V6H 3V4, Vancouver, BC, Canada. Srinivas.murthy@cw.bc.ca.

ABSTRACT

Background: Industry-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.

Methods: Clinical 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.

Results: Of 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).

Conclusions: More 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.

No MeSH data available.