It has previously been reported that while pharmaceutical companies fund approximately half of all biomedical research, the majority do not mandate open access to their trial results. The Publication Plan talked to Slávka Baróniková, Scientific Publications Leader at Galapagos, to hear her thoughts on open access publishing and to learn how open access policies can be implemented for industry-sponsored research. All opinions expressed in this piece reflect Slávka’s own personal views and experience.

You are a proponent of transparency and of open access publishing. While you were Publications Lead at Shire Pharmaceuticals the company introduced an open access publication policy, mandating that manuscripts reporting Shire-sponsored research are published in journals with open access options. What challenges did you encounter during this process?

“Personally, I did not experience many issues when establishing the open access policy at Shire. Although the ultimate goal is to publish open access, preferably under a CC-BY Creative Commons license, we also allowed for green open access [whereby an article is deposited in a freely-available repository once accepted by the journal]. In addition, in the therapy areas in which we worked, especially rare diseases, there is an understanding that information needs to be communicated with patients as soon as possible. Open access in these situations not only meets transparency initiatives put forth by movements such as Open Science and Open Pharma, but also fulfils the need of patients and patient organisations, as well as medical societies, to receive immediate access to peer-reviewed data with no barriers. Ensuring that publications were visible, even if not downloadable from the publisher’s site, was sufficient for us at that stage.

Although I did not experience a lot of resistance in establishing the open access policy, it did involve providing practical education to authors to explain the reasoning behind publishing open access, clarifying that it is not a promotional strategy but a science- and patient-centric approach to publication. I also had a lot of personal discussions with publishers to explain pragmatically why we were requesting open access. My current role is Scientific Publications Leader at Galapagos, where we have a similar approach, requesting for open access to ensure that there are no barriers to accessing scientific information.”

How might publication managers in other pharmaceutical companies initiate similar open access policies in the future?

“Some companies, such as Ipsen have already developed an open access policy. The introduction of such policies requires educating stakeholders and highlighting the benefits that open access publishing will bring to them. The definition of open access varies – using a strict definition of only publishing in full open access journals under a CC-BY license is the ideal scenario – however this is currently not possible in all journals. Another option is to apply a broader definition of open access, to ensure that there are no barriers to the discoverability and accessibility of their research. While certain public funders can mandate open access, research sponsored by pharmaceutical companies is restricted from full open access publication by some journals, which may be due to a fear of loss of revenue (eg from reprints).”

“Education and negotiation, both internally with researchers and externally with publishers, is key, as ultimately we all share the same goal of making science freely available.”

When selecting journals, authors may be more influenced by metrics such as impact factor than open access. How can publication professionals and publication managers advocate for open access in these cases?

“As a Publications Leader, I am engaged in discussions with publishers of different journals. I also believe that we are most effective when we work as a team and share ideas as a group. An example of such teamwork being put into effect is the development of a position statement on open access by Open Pharma. This statement clearly outlines the importance of open access, highlighting that it is not sought for marketing purposes but is patient-centric, with a goal of increasing openness, transparency and discoverability of research sponsored by pharmaceutical companies.

Conflicts can arise when an academic author’s institution quantifies their importance based on the number of publications they have in high-tier journals, which may not provide the option of open access publishing. This conflict raises the question of what the real value of the impact factor is – a topic that has been debated for a long time, even by publishers. I believe that the discoverability and accessibility of manuscripts, and fast publishing in appropriate target journals that provide high-quality peer-review, are more important than impact factor, but while many still hold this metric in high regard, it will continue to be a point of discussion.”

“When I am discussing journal options with authors, I emphasise that selecting a title that is a good fit for the paper, that has a thorough peer review process and allows data to be accessible and immediately discoverable will result in a quality paper being published in a quality journal, regardless of impact factor.”

Following the implementation of Shire’s open access policy, most manuscripts were published under the Creative Commons Attribution (CC-BY) license. Do you think authors and publication professionals are sufficiently informed about the different Creative Commons licenses and their implications? How do you think awareness could be increased?

“Open access and the legal implications of different licenses is a difficult topic to fully understand, and an area which I don’t think is very clear to many people.

Simplification of the Creative Commons licenses and reducing the number of options to one or two would help people to understand and use them.

There is a need for internal training from professionals. In my current position I am sharing practical advice on what the different options would mean for us and what we can or cannot do with papers published under each of the different licenses. This applies not only to papers that we are developing directly but also those which we might need to use.”

What more do you think needs to be done to increase open access publishing, by publishers, authors, medical publications professionals, pharmaceutical companies or other relevant parties?

“To increase open access publishing, pharmaceutical companies, medical publications professionals and authors should fully understand what open access means for them and look beyond traditional metrics (eg the impact factor). All parties need to consider the added value of open access to their target audiences, which today include not only scientists and healthcare practitioners but also patients and patient organisations. In addition, publishing open access has financial implications which need to be considered. Authors may have funders that mandate open access and support the associated costs, but there may be issues if, instead, institutions must pay open access fees. In this case, open access fees may need to be included in research budgets. From the perspective of the publisher, the main consideration is having a viable business model. While we demand high-quality peer-review and open access, the publishers need to be able to finance these, which can be challenging with the current business models of gold open access journals, where still the main source of income is journal subscriptions and article reprints. So, change is needed.”

Thinking more broadly about open access, in your opinion is the International Committee of Medical Journal Editors’ (ICMJE) requirement for a data sharing statement in manuscripts reporting clinical trial results sufficient? Should it be mandatory to share underlying data and how would such a requirement impact publication professionals? 

“The original proposal from the ICMJE was to share the data underlying clinical study results. This was met with a lot of pushback by both institutional researchers and pharmaceutical companies. In my opinion, this was useful feedback as it gave an insight into why researchers objected to the proposal.

To me the most important thing is to state whether or not data can be   shared and to have a process in place to ensure that when individual patient data are shared, it is done so responsibly.

The clinical study sponsor is in charge of sharing data in a responsible manner, as they are engaging with patients and have a responsibility to them and their data. Data sharing fosters further research from which patients can benefit. However, all data should not be freely shared without consideration either. Only proposals/hypothesis with a sound scientific basis, endorsed by a committee consisting of subject matter experts, should be considered for individual or aggregate data sharing. If patient identification is at stake (for example, if the data set is very small) then individual patient data should not be shared. If data are not being shared, an explanatory statement should be included.

There are also practical and technical aspects to consider when sharing data, to ensure usability for the data requesting party. To my knowledge the vast majority of pharmaceutical companies have in place, or are developing, processes for data sharing.”

Slávka Baróniková is Scientific Publications Leader at Galapagos NV. You can contact Slávka via Slavka.Baronikova@glpg.com.

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With thanks to our sponsor, Aspire Scientific Ltd

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