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

ABSTRACT: 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 1995-2000) 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=0.29) or publication status (P=0.08). However, we found a significant relationship between the types of sponsorship and of economic analysis (P=0.004), the health technology assessed (P<0.0001), and qualitative cost assessment (P=0.002). Studies with industrial sponsorship were 2.56 (99% lower confidence interval (CI)=1.28) times more likely to involve cost-minimisation analyses, were 0.04 (99% higher CI=0.39) times less likely to investigate diagnostic screening methods, and were 1.86 (99% lower CI=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 cost-minimisation analyses, to investigate less likely diagnostic screening methods, and to draw positive qualitative conclusions about costs, as compared to studies supported by nonprofit organisations.

SUBMITTER: Hartmann M

PROVIDER: S-EPMC2394350 | biostudies-other | 2003 Oct

REPOSITORIES: biostudies-other

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Project description:BackgroundClinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the pharmaceutical industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the pharmaceutical industry 2 years after publication of the primary results.Main textPubMed and ClinicalTrials.gov were searched to identify clinical trials of medicines sponsored by the pharmaceutical industry and first published between 1 July 2015 and 31 December 2015 in the top 10 general and internal medical journals by impact factor. For each clinical trial, the eligibility of independent researchers to request participant-level data was identified via the sponsor having a data sharing policy/process and a positive response to an enquiry. Fifty-six publications reporting on 61 industry-sponsored clinical trials were identified, of which 32 (52%) had a public data sharing policy/process and 9 (15%) were confirmed eligible for data sharing. Industry sponsors within the top 25 by global sales were more likely to have a data sharing policy (93% vs 10%), and there was a trend towards increased data sharing eligibility (23% vs 4%). Twenty-six studies were explicitly confirmed as ineligible for data sharing. The two most common data sharing policy conditions that prevented sharing of data for published results were the exclusion of studies that had ongoing follow-up of the published results and the exclusion of studies of medicines that have not yet achieved regulatory approval in the USA and the European Union.ConclusionsFifteen percent of the sampled clinical trials were available for data sharing 2 years after publication of primary results of the trial. Key issues limiting data sharing include a large proportion of industry sponsors who do not have a data sharing policy/process, and data sharing policy conditions that exclude access on the basis of ongoing follow-up and regulatory activity.

Project description:BackgroundMapping the international landscape of clinical trials may inform global health research governance, but no large-scale data are available. Industry or non-industry sponsorship may have a major influence in this mapping. We aimed to map the global landscape of industry- and non-industry-sponsored clinical trials and its evolution over time.MethodsWe analyzed clinical trials initiated between 2006 and 2013 and registered in the WHO International Clinical Trials Registry Platform (ICTRP). We mapped single-country and international trials by World Bank's income groups and by sponsorship (industry- vs. non- industry), including its evolution over time from 2006 to 2012. We identified clusters of countries that collaborated significantly more than expected in industry- and non-industry-sponsored international trials.Results119,679 clinical trials conducted in 177 countries were analysed. The median number of trials per million inhabitants in high-income countries was 100 times that in low-income countries (116.0 vs. 1.1). Industry sponsors were involved in three times more trials per million inhabitants than non-industry sponsors in high-income countries (75.0 vs. 24.5) and in ten times fewer trials in low- income countries (0.08 vs. 1.08). Among industry- and non-industry-sponsored trials, 30.3% and 3.2% were international, respectively. In the industry-sponsored network of collaboration, Eastern European and South American countries collaborated more than expected; in the non-industry-sponsored network, collaboration among Scandinavian countries was overrepresented. Industry-sponsored international trials became more inter-continental with time between 2006 and 2012 (from 54.8% to 67.3%) as compared with non-industry-sponsored trials (from 42.4% to 37.2%).ConclusionsBased on trials registered in the WHO ICTRP we documented a substantial gap between the globalization of industry- and non-industry-sponsored clinical research. Only 3% of academic trials but 30% of industry trials are international. The latter appeared to be conducted in preferentially selected countries.

Project description:BACKGROUND: Dietary supplement use is increasing despite lack of evidence of benefits, or evidence of harm. Press releases issued by the supplements industry might contribute to this situation by using 'spin' (strategies to hype or denigrate findings) to distort the results of clinical studies. We assessed press releases issued in response to publication of clinical studies on dietary supplements. METHODS AND FINDINGS: We analyzed 47 supplements industry press releases and 91 non-industry press releases and news stories, generated in response to 46 clinical studies of dietary supplements published between 1/1/2005 and 5/31/2013. The primary outcome was 'spin' content and direction. We also assessed disposition towards use of dietary supplements, reporting of study information, and dissemination of industry press releases. More supplements industry press releases (100%) contained 'spin' than non-industry media documents (55%, P<0.001). Hyping 'spin' scores were higher in industry than non-industry media documents for studies reporting benefit of supplements (median 'spin' score 3.3, 95% CI 1.0-5.5 vs 0.5, 0-1.0; P<0.001). Denigratory 'spin' scores were higher in industry than non-industry media documents for studies reporting no effect (6.0, 5.0-7.0 vs 0, 0-0; P<0.001) or harm (6.0, 5.5-7.5 vs 0, 0-0.5; P<0.001) from a supplement. Industry press releases advocated supplement use in response to >90% of studies that reported no benefit, or harm, of the supplement. Industry press releases less frequently reported study outcomes, sample size, and estimates of effect size than non-industry media documents (all P<0.001), particularly for studies that reported no benefit of supplements. Industry press releases were referenced by 148 news stories on the websites of 6 organizations that inform manufacturers, retailers and consumers of supplements. CONCLUSIONS: Dietary supplements industry press releases issued in response to clinical research findings are characterized by 'spin' that hypes results that are favourable to supplement use and denigrates results that are not.

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

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