Dataset Information

Industry-university collaborations in Canada, Japan, the UK and USA--with emphasis on publication freedom and managing the intellectual property lock-up problem.

ABSTRACT: As industry-university collaborations are promoted to commercialize university research and foster economic growth, it is important to understand how companies benefit from these collaborations, and to ensure that resulting academic discoveries are developed for the benefit of all stakeholders: companies, universities and public. Lock up of inventions, and censoring of academic publications, should be avoided if feasible. This case-study analysis of interviews with 90 companies in Canada, Japan, the UK and USA assesses the scope of this challenge and suggests possible resolutions. The participating companies were asked to describe an important interaction with universities, and most described collaborative research. The most frequently cited tensions concerned intellectual property management and publication freedom. IP disagreements were most frequent in the context of narrowly-focused collaborations with American universities. However, in the case of exploratory research, companies accepted the IP management practices of US universities. It might make sense to let companies have an automatic exclusive license to IP from narrowly defined collaborations, but to encourage universities to manage inventions from exploratory collaborations to ensure development incentives. Although Canada, the UK and US have strong publication freedom guarantees, tensions over this issue arose frequently in focused collaborations, though were rare in exploratory collaborations. The UK Lambert Agreements give sponsors the option to control publications in return for paying the full economic cost of a project. This may offer a model for the other three countries. Uniquely among the four countries, Japan enables companies to control exclusively most collaborative inventions and to censor academic publications. Despite this high degree of control, the interviews suggest many companies do not develop university discoveries to their full potential. The steps suggested above may rebalance the situation in Japan. Overall, the interviews reveal the complexity of these issues and the need for flexibility on the part of universities and companies.

SUBMITTER: Kneller R

PROVIDER: S-EPMC3954545 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

Industry-university collaborations in Canada, Japan, the UK and USA--with emphasis on publication freedom and managing the intellectual property lock-up problem.

Kneller Robert R Mongeon Marcel M Cope Jeff J Garner Cathy C Ternouth Philip P

PloS one 20140314 3

As industry-university collaborations are promoted to commercialize university research and foster economic growth, it is important to understand how companies benefit from these collaborations, and to ensure that resulting academic discoveries are developed for the benefit of all stakeholders: companies, universities and public. Lock up of inventions, and censoring of academic publications, should be avoided if feasible. This case-study analysis of interviews with 90 companies in Canada, Japan, ...[more]

PMID: 24632805

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Project description:OBJECTIVE:To gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry. DESIGN/SETTING:Web-based survey publicised via email and social media to members of the International Society for Medical Publication Professionals (ISMPP) and other organisations from November 2012 to February 2013. PARTICIPANTS:469 individuals involved in publishing industry-sponsored research in peer-reviewed journals, mainly working in pharmaceutical or device companies ('industry', n=144), communication agencies ('agency', n=238), contract research organisations (CRO, n=15) or as freelancers (n=34). Most respondents (78%) had worked on medical publications for ?5 years and 62% had a PhD/MD. RESULTS:Over 90% of industry, agency and CRO respondents routinely refer to Good Publication Practice (GPP2) and the International Committee of Medical Journal Editors' Uniform Requirements. Most respondents (78% industry, 79% agency) received mandatory training on ethical publication practices. Over 90% of respondents' companies had publication guidelines or policies and required medical writing support to be acknowledged in publications (96% industry, 99% agency). Many industry respondents used publication management tools to monitor compliance with company guidelines and about half (46%) stated that their company had formal publication audits. Fewer agencies audited adherence to guidelines but 20% of agency respondents reported audits of employees and 6% audits of freelancers. Of concern, 37% of agency respondents reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines. Most respondents' departments (63% industry, 58% agency, 60% CRO) had been involved in publishing studies with negative or inconclusive results. CONCLUSIONS:Within this sample, most publication professionals working in or for industry were aware of, and applying, major publication guidelines. However, the survey also identified specific areas where education and promotion of guidelines are needed to ensure ethical publication practices.

Project description:Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The 'open access' approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The 'restricted access' approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who 'needs to know' about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results.

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.

Dataset Information

Industry-university collaborations in Canada, Japan, the UK and USA--with emphasis on publication freedom and managing the intellectual property lock-up problem.

Publications

Industry-university collaborations in Canada, Japan, the UK and USA--with emphasis on publication freedom and managing the intellectual property lock-up problem.

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