At this year’s ISMPP European meeting, a panel of Open Pharma members discussed open access, preprints and post-publication peer review, and the possibility of utilizing these tools to make the publishing of pharmaceutical research faster and more transparent.
Moderator: Richard Smith
“In driving change in medical publishing, pharmaceutical companies are conspicuous by their absence, in spite of funding probably over half of all medical research”
“For us, and any pharma company, we have a clock that starts ticking as soon as data collection is complete. We can pretty much control the period between Last Patient Last Visit and completing the manuscript, but once we submit, those time frames are out of our hands.
What I find so interesting is the speed of preprints. We post the results in compliance with US FDA and EMA regulations, but these don’t have context. To be able to put these results out in context so quickly is an interesting opportunity”
“BMJ Journals, and a large number of other journals, are happy to receive preprinted articles but some, such as the New England Journal of Medicine, are not. It is important to check your target journal’s position first. That being said, most publishers say ‘we think that we provide enough value that we’re not worried about preprinted articles’”
“I remain a publisher at heart but now, as an independent, do not claim to speak for all publishers. However, the vast majority of medical journals have fully embraced open access and CC BY. The bump in the road for some is the society-owned journals that do not offer open access let alone CC BY. These are published under contract, where the societies have the final say. So, to be fair to the publishers, it is the society boards that are the issue. These boards include clinicians, who are naturally risk-averse, so the concepts of open access and CC BY are frequently deemed to be ‘just too risky’”
“For a subject with so much noise and obfuscation around it, open access is a very simple idea. Articles should be made freely available at the time of publication without limitations on reuse. The mission of Wellcome is to improve human health and the best way for us to achieve that is to ensure that our primary outputs – our articles – are accessible for the whole world. Where Wellcome has led, many other research funders have followed”
“Articles on F1000Research begin as preprints but then immediately start invited peer review by experts, as with any journal, followed by PubMed indexing; the main difference from traditional journals is that our peer review happens after posting and is completely transparent. This open peer review avoids a false reliance on the safe harbour of closed review, where numerous high-profile articles have been published and then found to be wrong, and it turns out the anonymous peer reviewers had flagged concerns but these were ignored and not made public. This approach enables a very rapid publication process (2–3 months from submission to indexing) and significantly reduces open access charges ($150–1000 depending on article size)”
“GSK already strongly recommends open access and, when permitted by the journal, publishing with a CC BY licence, which GSK pays for at fair market value. It is already the case that, even without a formal policy, 85–90% of papers from GSK Vaccines are published with some form of open access. Journal choice still lies with the author and better clarity around certain aspects, such as clarity on journal/publisher open access policies, is needed prior to any formal position around open access”
“When we suggested an open access policy for Shire, some were concerned an open access policy could limit authors’ flexibility in their journal choice. The lightbulb moment came when Robert [Kiley] pointed out that biopharma, as major funders of medical research, has the ability to effect change. Researchers are used to having stipulations put on their funding by prominent funders such as Wellcome, the Bill & Melinda Gates Foundation and the EU. The benefits of open access to researchers, healthcare professionals and patients, and the innovation and research on future treatments it will encourage, especially for rare diseases, outweigh any perceived downside. Shire is committed to fostering a culture of transparency, and we hope that companies will consider many different approaches to how they share research and clinical trial data”
“When open access was new, there were concerns that article processing charges or fees could be considered paying for publication, but those have largely gone. While GPP3 says that journal choice is primarily an author decision, an open access policy still offers a choice, within certain criteria. Pharma is not used to taking the lead like this because they are so heavily scrutinized and regulated, but a mandatory open access policy is likely to attract wide-ranging support”
The audience was asked whether pharma should think about using open access, preprints and post-publication peer review when sharing the research it funds and the answer was a resounding ‘Yes’. While preprints and post-publication peer review are currently viewed as more adventurous, there is progress on open access. Shire’s industry-leading open access policy is impressive and in a year’s time it is likely that others will have followed their lead; indeed, the audience was asked whether they would be likely to follow Shire in moving towards implementing an open access mandate and the results of the poll were promising. A key component of open access is CC BY licences and, if pharma says ‘we want this kind of licence’, publishers will make it happen.