A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design.
A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design.
复制标题
DOI：
10.1186/1745-6215-15-31
复制
发表时间：
2014-01-22
期刊：
影响因子：
2.5
通讯作者：
Hicks CB
中科院分区：
文献类型：
--
作者：
Goswami ND;Tsalik EL;Naggie S;Miller WC;Horton JR;Pfeiffer CD;Hicks CB
随着联邦学术研究基金的减少，特别是在艾滋病毒/艾滋病和丙型肝炎（HCV）领域，由工业界赞助的临床研究的比例可能会继续扩大。虽然HIV和HCV继续给美国人口带来负担，但关于行业赞助如何影响涉及这些传染病的临床试验的数据不足。关于制药公司是否进行更多的市场驱动的研究实践以促进治疗，或者由于资源和审查的增加而进行比非行业同行更严格的试验，存在争议。ClinicalTrials.gov注册中心允许研究者履行联邦关于公开试验注册的授权，为独立于出版状态的行业申办试验的研究设计提供了批判性评价的机会。作为大型公共政策努力的一部分，临床试验转化倡议（CTTI）最近将ClinicalTrials.gov注册表转化为可搜索的数据集，以促进对临床试验本身的研究。我们对2007年10月1日至2010年9月27日在ClinicalTrials.gov注册的477项HIV和HCV药物治疗试验进行了横断面分析，以研究研究赞助与随机研究设计的关系。根据流行率（PR）报告了使用随机化的可能性（考虑到行业（与非行业）赞助）。使用粗略和分层表格分析和Poisson回归估计PR，调整了数据监查委员会的存在、入组规模、研究分期、研究中心数量、外国研究中心的纳入、65岁以上人群的排除和疾病状况。粗PR为1.17（95% CI 0.94，1.45）。调整后的泊松模型产生的PR为1.13（95% CI 0.82，1.56）。研究阶段存在轻度效应指标修改的趋势，但无统计学显著性。在分层表格分析中，2/3期试验中校正的PR为1.14（95% CI 0.78，1.68），4期试验中为1.06（95% CI 0.50，2.22）。在这项横断面研究中，未发现行业赞助与试验设计中随机化的使用之间存在显著关系。评价试验设计其他方面的前瞻性研究可能会进一步阐明行业赞助与适当试验方法之间的关系。
The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves. We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition. The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials. No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology.
登录
查看更多内容
影响因子：
15.8
作者：
Ross JS;Mulvey GK;Hines EM;Nissen SE;Krumholz HM
通讯作者：
Krumholz HM
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：
12.7
作者：
Ross, Joseph S.;Gross, Cary P.;Krumholz, Harlan M.
通讯作者：
Krumholz, Harlan M.
影响因子：
120.7
作者：
Dorsey, E. Ray;de Roulet, Jason;Moses, Hamilton, III
通讯作者：
Moses, Hamilton, III
影响因子：
2.2
作者：
Roumiantseva, Dina;Carini, Simona;Wagner, Todd H.
通讯作者：
Wagner, Todd H.