Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013.
Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013.
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DOI：
10.1186/s12961-015-0019-6
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发表时间：
2015-06-05
影响因子：
4
通讯作者：
Bourgeois FT
中科院分区：
文献类型：
--
作者：
Murthy S;Mandl KD;Bourgeois FT
工业界赞助的临床试验过去几乎只在较发达国家进行，现在往往在全球范围内招募参与者。然而，从高收入国家以外招募的人员可能并不代表干预措施的最终目标人群。临床试验注册提供了一个机会，可以量化和检查在不同地理区域进行的临床研究类型。我们试图描述在高收入国家进行的行业申办的随机对照试验，并将这些试验与在高收入国家以外进行的试验进行比较。2006年至2014年期间进行的所有行业资助的随机对照试验的临床试验数据均来自注册中心ClinicalTrials.gov。根据在高收入或非高收入国家进行的研究中心对试验进行分类，并收集试验特征数据。在22，511项相关试验中，共有6，085项（27.0%）试验包括高收入国家以外的研究中心，2，045项（9.1%）试验仅在高收入国家以外进行。在国家组中，中欧的试验数量最多（3 127项），其次是东欧（2 075项）。在高收入国家以外的研究中心进行的试验百分比在研究期间保持相对稳定。在高收入国家以外的研究中心进行的研究倾向于招募更多的受试者（中位入组受试者265 vs. 71，P <0.001），时间更长（中位研究持续时间20 vs. 13个月，P <0.05），研究更先进的阶段干预措施（3期或4期试验58% vs. 33%，P <0.001）。超过四分之一的行业赞助的试验包括来自高收入国家以外的参与者，这一比例在7年的研究期间保持稳定。与仅在高收入国家进行的研究相比，在高收入国家以外进行的试验往往规模更大，持续时间更长，并且研究后期干预措施。本文的在线版本（doi：10.1186/s12961-015-0019-6）包含补充材料，可供授权用户使用。
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. 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. 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). 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. The online version of this article (doi:10.1186/s12961-015-0019-6) contains supplementary material, which is available to authorized users.
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DOI：
10.1056/nejmsa1012065
发表时间：
2011-03-03
期刊：
The New England journal of medicine
影响因子：
--
作者：
Zarin DA;Tse T;Williams RJ;Califf RM;Ide NC
通讯作者：
Ide NC
影响因子：
15.8
作者：
Ana J;Koehlmoos T;Smith R;Yan LL
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Yan LL
影响因子：
168.9
作者：
Lozano, Rafael;Naghavi, Mohsen;Murray, Christopher J. L.
通讯作者：
Murray, Christopher J. L.
影响因子：
4.1
作者：
Lorenzo, Claudio;Garrafa, Volnei;Vidal, Susana
通讯作者：
Vidal, Susana
DOI：
10.1016/s0197-2456(97)00150-5
发表时间：
1998-04-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Vickers, A;Goyal, N;Rees, R
通讯作者：
Rees, R