TY - JOUR
T1 - A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010
T2 - The relationship between industry sponsorship and randomized study design
AU - Goswami, Neela D.
AU - Tsalik, Ephraim L.
AU - Naggie, Susanna
AU - Miller, William C.
AU - Horton, John R.
AU - Pfeiffer, Christopher D.
AU - Hicks, Charles B.
N1 - Funding Information:
This work was supported by a grant from the FDA awarded to Duke University. The study sponsor had no role in the design or performance of this study, or in the writing of the manuscript. We would like to thank Karen Chiswell, Sara Calvert, and Asba Tasneem for facilitating our use of data in the ClinicalTrials.gov registry. Ephraim Tsalik was supported by Award Number 1IK2CX000530 from the Clinical Science Research and Development Service of the Veterans Health Administration Office of Research and Development.
Funding Information:
CBH has research funded by Argos, BMS, Gilead, Viiv, and Merck and serves on the scientific advisory committee for BMS, Gilead, Merck, Viiv, and Jansen Virology. SN serves on an advisory board for Vertex and Boehringer Ingelheim and receives grant support from Vertex, Anadys, Synexis, BMS, and Medtronic.
Funding Information:
Over the past 15 years, the proportion of clinical research sponsored by the pharmaceutical industry has increased and likely will continue to expand as federally funded research at academic centers faces massive cuts [1]. In 2000, 70% of the clinical drug trial enterprise was funded by industry rather than by the National Institutes of Health (NIH), and as of 2010 this proportion is increasing [2,3]. Pharmaceutical companies fill a critical need by providing substantial upfront investment in the drug development process. This is particularly evident with chronic diseases that may have a low event rate over a long period of time. It is, however, axiomatic that business interests are a primary consideration in this process, and generation of profits over time is thus a central necessary theme. This may not always align with the goal of identifying the most effective treatments that maximize public health [4,5].
PY - 2014/1/22
Y1 - 2014/1/22
N2 - Background: 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.Methods: 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.Results: 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.Conclusions: 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.
AB - Background: 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.Methods: 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.Results: 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.Conclusions: 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.
KW - Bias
KW - Industry
KW - Methodology
KW - Pharmaceutical
KW - Randomization
KW - Trial
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U2 - 10.1186/1745-6215-15-31
DO - 10.1186/1745-6215-15-31
M3 - Article
C2 - 24450313
AN - SCOPUS:84892654848
SN - 1745-6215
VL - 15
JO - Trials
JF - Trials
IS - 1
M1 - 31
ER -