Constraints on Publication Rights in Industry-Initiated Clinical Trials
Available from: Andreas Lundh
- "Many industry-sponsored trials are coordinated by seemingly independent steering committees. However, this may not prevent sponsor influence, as academic authors often have constraints on publication rights [8,9], the sponsor often owns the data [9,10], ghost authorship is common , and academic authors may have industry ties . "
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Bias in industry-sponsored trials is common and the interpretation of the results can be particularly distorted in favour of the sponsor’s product. We investigated sponsors’ involvement in the conduct and reporting of industry-sponsored trials.
We included all industry-sponsored trials published in The Lancet in 2008 and 2009 and corresponding trial protocols provided by The Lancet. For each protocol and publication, we extracted information on trial conduct and reporting.
We identified 169 publications of randomised trials and included 69 (41%) that were industry-sponsored, and 12 (7%) industry-funded but seemingly independently conducted as a subsample. Entry of data into the study database was done independently by academic authors without the involvement of the sponsor or a contract research organisation in one of the 69 trials. Two trials had independent data analysis and one independent reporting of results. In 11 of the trials, there was a discrepancy between the information in the protocols and papers concerning who analysed the data. In four of the 12 seemingly independent trials, the protocol described sponsors’ involvement in writing the report while the published paper explicitly stated that the sponsor was not involved.
The sponsors are usually involved in the analysis and reporting of results in industry-sponsored trials, but their exact role is not always clear from the published papers. Journals should require more transparent reporting of the sponsors’ role in crucial elements such as data processing, statistical analysis and writing of the manuscript and should consider requiring access to trial protocols, independent data analysis and submission of the raw data.
Available from: Haya Ascher-Svanum
- "n , particularly inadequate allocation conceal - ment , has long been reported as a potential reason for overestimation of efficacy ( Gotzsche et al . , 2006 ; Juni et al . , 2001 ; Schulz et al . , 1994 ) . Recently , it has also been suggested that trials of antipsychotics in patients with schizophrenia sponsored by the pharmaceutical industry ( Gotzsche et al . , 2006 ; Leucht et al . , 2009b ) or trials administering higher doses of olanzapine ( Parks et al . , 2009 ) might influence the effectiveness of treatment . While this study found some significant differences in results when studies were divided according to method of allocation concealment ( adequate vs . unclear ) , sponsor of studies ( pu"
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ABSTRACT: Objective: This comprehensive review and meta-analysis compared the effectiveness of olanzapine and other antipsychotics in schizophrenia treatment, defining effectiveness as time to all-cause medication discontinuation (primary) and as all-cause treatment discontinuation rates. This study examined randomized clinical trials (RCTs) and observational non-interventional studies. Experimental procedures: Schizophrenia studies that compared olanzapine with individual first- (FGAs) and/or second-generation antipsychotics (SGAs) were included in the meta-analyses. Hazard ratios (HR), risk ratios (RR), and their associated 95% confidence intervals were extracted for RCTs and observational studies. Sensitivity analyses assessed the impact of sources of funding, dose of olanzapine, and allocation concealment method on final results. Results: There were 60 RCTs (N=33,360) and 27 observational studies (N=202,591) included. On time to all-cause medication discontinuation, olanzapine was significantly better than aripiprazole, quetiapine, risperidone, ziprasidone and perphenazine for RCTs and better than amisulpride, risperidone, haloperidol, and perphenazine for observational studies. There were no significant differences between olanzapine and clozapine in RCTs or observational studies. All-cause discontinuation rates in RCTs were significantly lower for olanzapine compared to all comparators except amisulpride and clozapine. In observational studies, olanzapine was less effective than clozapine. Industry-sponsored studies favored olanzapine when compared to haloperidol and perphenazine; higher dose of olanzapine favored quetiapine and perphenazine when compared to olanzapine; method of allocation concealment did not generally affect the results. Conclusion: Using a global measure of medication effectiveness (time to all-cause medication discontinuation), olanzapine appears to be more effective - in both RCTs and observational studies - than most SGAs and FGAs, except for clozapine.
Available from: PubMed Central
- "3) Any separate agreements between sponsor and investigators that are not included in the protocol, for example on finances, ownership of data and publication rights. Thirteen of 44 protocols of industry-initiated trials from 2004 referred to a separate publication agreement, compared with none of 44 protocols from 1994-1995, and none of these agreements were submitted to the Scientific-Ethical Committees . "
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ABSTRACT: International calls for registering all trials involving humans and for sharing the results, and sometimes also the raw data and the trial protocols, have increased in recent years. Such calls have come, for example, from the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO), the US National Institutes of Heath, the US Congress, the European Commission, the European ombudsman, journal editors, The Cochrane Collaboration, and several funders, for example the UK Medical Research Council, the Wellcome Trust, the Bill and Melinda Gates Foundation and the Hewlett Foundation.
Calls for data sharing have mostly been restricted to publicly-funded research, but I argue that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests.
I also argue why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available. Respect for trial participants who often run a personal and unknown risk by participating in trials requires that they - and therefore also the society at large that they represent - be seen as the ultimate owners of trial data.
Data sharing would lead to tremendous benefits for patients, progress in science, and rational use of healthcare resources based on evidence we can trust. The harmful consequences are minor compared to the benefits. It has been amply documented that the current situation, with selective reporting of favorable research and biased data analyses being the norm rather than the exception, is harmful to patients and has led to the death of tens of thousands of patients that could have been avoided.
National and supranational legislation is needed to make data sharing happen as guidelines and other voluntary agreements do not work. I propose the contents of such legislation and of appropriate sanctions to hold accountable those who refuse to share their data.
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