Industry Funding of Clinical Trials: Benefit or Bias?

Chopra, Sameer

doi:10.1001/jama.290.1.113

Cited by 104 publications

(78 citation statements)

References 38 publications

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“…Any harm that has occurred is not put in the public forum and the potential to avoid making similar errors is lost. 21,22 Tragically, the events of the trial of the monoclonal antibody TGN1412 identified the potential for harm to occur in such studies. 23,24 To reduce publication bias, there is evidence that registration of clinical trials in a publicly accessible database leads to more open disclosure of meaningful trial data.…”

Section: Discussionmentioning

confidence: 99%

Publication bias in the medical literature: A review by a Canadian research ethics board

2007

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Background:We reviewed the publication record of all protocols submitted to the Capital District Health Authority Research Ethics Board (REB) in Halifax, Nova Scotia, for the period 1995-1996. Because of a heightened awareness of the issue, we hypothesized that there would be less publication bias (a failure to report negative results) and a higher publication rate from completed studies, than previously reported. Methods:Closed studies were identified from the REB database. Publications were identified by the investigators, requests from sponsors, and a literature review. For each publication, we identified authors, title, journal, number of subjects enrolled, and whether or not the publication was a report of a randomized clinical trial. Comparisons were done using a Student's t test, the Chi-square statistic, or Fisher's exact test as appropriate.Results: From the database of closed studies, 106 remained unpublished, while completed investigations resulted in 84 publications (44% publication rate). The median time to publication was 32.5 months. Publication of statistically significant results occurred in 71/84 trials. Publication of protocols submitted by departments ranged from 91% (anesthesia; 10/11) to 25% [nursing; 2/8 (P < 0.05)]. Trials investigating new drugs in Phase 3 or 4 studies were more likely to be published than trials investigating agents in Phase 1 or 2 (P < 0.05), and were less likely to be published if sponsored by a pharmaceutical company (P < 0.05). Conclusions: Publication bias continues to be a problem, particularly for early phase investigative studies. Our results suggest that a different approach is required to reduce publication bias. The role that REBs and peer-reviewed journals might play requires further exploration. CAN J ANESTH 2007 / 54: 5 / pp 380-388 Contexte : Nous avons passé en revue le fichier de publications de tous les protocoles soumis au Comité d'éthique de recherche (CER) du Capital District Health Authority à Halifax, Nouvelle Écosse, pour la période 1995-1996. Étant fortement sensibilisés à la question, nous avons émis l'hypothèse qu'il y aurait moins de biais de publication (le fait que des résultats négatifs ne soient pas rapportés) ainsi qu'un taux de publication plus élevé d'études achevées que ce qui avait été précédemment rapporté. Méthode

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Section: Discussionmentioning

confidence: 99%

Publication bias in the medical literature: A review by a Canadian research ethics board

2007

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“…Therefore, establishing checks and balances for academic -industry partnership, as it is proposed for clinical studies (Chopra, 2003), may help to mitigate the potential for bias in health economics. Industry-vs nonprofit-sponsored economic studies M Hartmann et al…”

Section: Discussionmentioning

confidence: 99%

Industry-sponsored economic studies in oncology vs studies sponsored by nonprofit organisations

et al. 2003

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The purpose of this analysis of health economic studies in the field of oncology was to investigate among sponsored studies whether any relationship could be established between the type of sponsorship and (1) type of economic analysis, (2) health technology assessed, (3) sensitivity analysis performed, (4) publication status, and (5) qualitative conclusions about costs. The Health Economic Evaluations Database (HEED, version 1995(HEED, version -2000 was searched on the basis of oncological ICD-9 codes, sponsorship, and comparative studies. This search yielded a total of 150 eligible articles. Their evaluations were prepared independently by two investigators, on the basis of specific criteria. When evaluators disagreed, a third investigator provided a deciding evaluation. There was no statistically significant relationship between the type of sponsorship and sensitivity analysis performed (P ¼ 0.29) or publication status (P ¼ 0.08). However, we found a significant relationship between the types of sponsorship and of economic analysis (P ¼ 0.004), the health technology assessed (Po0.0001), and qualitative cost assessment (P ¼ 0.002). Studies with industrial sponsorship were 2.56 (99% lower confidence interval (CI) ¼ 1.28) times more likely to involve cost-minimisation analyses, were 0.04 (99% higher CI ¼ 0.39) times less likely to investigate diagnostic screening methods, and were 1.86 (99% lower CI ¼ 1.21) times more likely to reach positive qualitative conclusions about costs than studies supported by nonprofit organisations. In conclusion, our results suggest that there is a greater probability that industry-sponsored economic studies in the field of oncology tend to be costminimisation analyses, to investigate less likely diagnostic screening methods, and to draw positive qualitative conclusions about costs, as compared to studies supported by nonprofit organisations. There has long been discussion as to whether commercial sponsorship of clinical studies produces a conflict of interests (Davidson, 1986;Rochon et al, 1994;Krimsky and Rothenberg, 1998;Smith, 1998;Stelfox et al, 1998;Montaner et al, 2001;Morin et al, 2002). However, only two applied studies deal with this issue for health economic studies conducted in the field of oncology. Friedberg et al (1999) found that, in the case of new drugs developed for oncological use (including haematopoietic growth factors, antiemetics, taxanes), pharmaceutical sponsorship of economic analyses was associated with a low likelihood of reporting unfavourable results. Subsequently, however, the same authors moderated these conclusions about costs in a comparison of industry vs nonprofit-sponsored economic analyses of six novel drugs used in oncology (Knox et al, 2001). After reviewing all the available pharmacoeconomic reports, they established the differences in study reporting -but not in the types of journals in which the studies were published -between pharmaceutical companyand non-profit-sponsored studies. They concluded that these results, and in particular the...

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“…14 While Health Canada requires that budgets be included in clinical trial agreements (CTAs), the necessary level of detail is not specified, and CTAs or any financial agreements are not considered part of their inspection process. 15 The lack of standardization has resulted in a poor understanding of trial budget requirements. It is therefore important that Canadian studies be conducted to determine if there is empirical support for the belief that cancer clinical trial patients consume more resources and, if so, which areas incur the highest costs.…”

Section: Introductionmentioning

confidence: 99%

Incremental costs of prostate cancer trials: Are clinical trials really a burden on a public payer system?

Jones¹,

Syme²,

Eliasziw³

et al. 2012

CUAJ

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Introduction: Clinical trials are a critical component of improving cancer prevention and treatment strategies. However, the perception that patients enrolled in trials consume more resources than those receiving the standard-of-care (SOC) has contributed to an increasingly research-averse environment. Current economic data pertaining to the per-patient costs of prostate cancer trials relative to SOC treatment are limited. Methods: A retrospective observational cohort study was conducted to compare costs incurred by 59 prostate cancer patients participating in a mix of industry and non-industry sponsored clinical trials with costs incurred by an equal number of eligible nonparticipants who received SOC over a year. Resource utilization was tracked and quantified to standardized price templates. Results: No difference in overall resource utilization was seen between trial and SOC patients (two-tailed t-test, n = 118, p = 0.99). Variability in the types of resources used by each group indicated that, while trial patients may take up significantly more clinic time (p = 0.001) and undergo more tests and procedures (p = 0.001), SOC patients are more likely to receive other costly interventions, such as radiation therapy (p < 0.001). Other variables (e.g., pathology, diagnostic imaging, prescribed therapies) were statistically indistinguishable between groups. Conclusion: This study revealed differences in the cost distribution of patients enrolled in clinical trials versus those receiving SOC, which could be used to improve resource allocation. The lack of evidence for a difference in overall cost provides an argument for payers to more fully support clinical research without fear of adverse financial consequences. Further analysis is required.

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Industry Funding of Clinical Trials: Benefit or Bias?

Cited by 104 publications

References 38 publications

Publication bias in the medical literature: A review by a Canadian research ethics board

Publication bias in the medical literature: A review by a Canadian research ethics board

Industry-sponsored economic studies in oncology vs studies sponsored by nonprofit organisations

Incremental costs of prostate cancer trials: Are clinical trials really a burden on a public payer system?

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