Pharmaceutical company–sponsored drug trials: the system is broken

Gartlehner, Gerald; Fleg, Anthony

doi:10.1016/j.jclinepi.2009.07.015

Cited by 5 publications

(4 citation statements)

References 7 publications

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“…Moreover, when conducted, most head-to-head trials do not intend to prove superiority but rather try to show similar efficacy to point out the advantage of the sponsored drug on other outcomes, such as specific adverse events or for certain subgroups. 32 Our study has some limitations. First, ClinicalTrials .gov records are probably not always comprehensive, and we had to extrapolate from available information; for example, we assumed no specific RA cointervention if none was reported.…”

Section: Commentmentioning

confidence: 89%

Lack of Head-to-head Trials and Fair Control Arms

Estellat

Ravaud²

2012

Arch Intern Med

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Section: Commentmentioning

confidence: 89%

Lack of Head-to-head Trials and Fair Control Arms

Estellat

Ravaud²

2012

Arch Intern Med

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“…Nevertheless, as we have indicated in an earlier commentary, we strongly believe that the way medical research is being conducted and disseminated has become out of scale [9]. More fundamental changes than research programs on funding biases are necessary.…”

mentioning

confidence: 90%

Comparative effectiveness reviews and the impact of funding bias

Gartlehner

Fleg

2010

Journal of Clinical Epidemiology

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“…Such trials have been prone to publication bias, in favor of the industry-sponsored drug, limiting the usefulness of the results [17][18][19][20]. It is possible, but unclear, if this sponsorship influenced the results of this post-hoc analysis.…”

mentioning

confidence: 99%

Effect of Body Mass Index on Treatment of Complicated Intra-Abdominal Infections in Hospitalized Adults: Comparison of Ertapenem with Piperacillin-Tazobactam

Zakrison

Hille²,

Namias³

2012

Surgical Infections

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There was no difference in the cure rate of patients with cIAI in the BMI <30 and BMI ≥30 kg/m(2) groups. There were no statistically significant differences in the likelihood of response to an antibiotic regimen. However, there was a nominally 21% lower cure rate in the high BMI group receiving piperacillin-tazobactam (86% vs. 65%; 21% difference in proportions; 95% CI -1%, 47%), whereas there was only a 1% difference in the cure rate between BMI groups in the patients receiving ertapenem. This difference may be related to gender and etiology of infection. Although limited by the small number of high BMI patients and post-hoc methodology, these results merit consideration of the design of future prospective antibiotic trials to include stratification for BMI and consideration of the effect of BMI on pharmacokinetics and pharmacodynamics.

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Pharmaceutical company–sponsored drug trials: the system is broken

Cited by 5 publications

References 7 publications

Lack of Head-to-head Trials and Fair Control Arms

Lack of Head-to-head Trials and Fair Control Arms

Comparative effectiveness reviews and the impact of funding bias

Effect of Body Mass Index on Treatment of Complicated Intra-Abdominal Infections in Hospitalized Adults: Comparison of Ertapenem with Piperacillin-Tazobactam

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