Contributed by Dr. Karin Purshouse 

Can you feel that breeze?  It’s the cool air coming off a wave of publishing in the COVID19 era. 

As a clinician scientist, I live between two worlds.  In the scientific research world, and as an academic in the UK, open access is increasingly the norm.  My funding requires it and my institution supports it.  Article Processing Fees (APCs) are often part of academic funding, either formally or by application, and pre-print publishing is on the rise.

Flip over to the clinical world, and the story is quite different. Clinicians also publish their work in scientific or medical journals, but open access may not be possible unless an author is a funded clinical academic.  As a junior clinician, most of my clinical research was part of my clinical job, for which there is no funding for APC publishing. Clinicians often do not have access to pay-walled research articles, so unless something is published open access, they cannot read it. It’s a catch-22 – clinicians often can’t pay to publish open access, but they must pay to read closed access research.  This disproportionately affects our colleagues in low and middle income countries.  The internet has allowed the clinical community to respond in its own way through websites like Life In The Fast Lane (LITFL), creating a whole new area of Free Open Access Meducation aka #FOAMed.  Nonetheless, the evidence contained within is often from journal articles. 

The need for open access, and specifically pre-print, publishing in clinical research has been demonstrated clearly during the COVID19 pandemic.  Research can immediately be shared openly – a huge advantage over the closed peer-review process.  That speed is vital.  COVID19 is unlike anything the world has ever experienced, and we are hungry for evidence.  In my field of oncology, there is real concern about how we find a way forward for patients with cancer in a world where COVID19 is likely to be endemic until a vaccine is found.  Pre-COVID, a delay of a few weeks in finding out a crucial piece of clinical research data may not have mattered.  Now, with thousands of patients around the world having diagnoses and treatments delayed or rationalised, every week matters.  Pre-prints also mean authors can be credited earlier, and opportunities for shared working might be identified sooner.  If you and a fellow clinician have similar interests, a pre-print might alert you to the potential for collaboration. 

Many critics of pre-prints cite the lack of peer review as a problem – that the work hasn’t been checked for fundamental errors or methodological flaws by expert review.  Peer-review is no guarantee of good quality work, though.  Early during the pandemic, a study on a treatment for COVID19 was published in a high impact journal despite no control arm and small numbers. Its publication in a peer-reviewed journal was no protection from the limited generalisability of its findings, and meant it got major publicity through its publication in a high-profile journal.   By contrast, major findings have come out in pre-print form and therefore essentially undergone peer-review by the entire clinical community in real-time.  In addition, pre-print servers generally state clearly that articles have not been peer-reviewed, with comments and critique from readers clearly visible – this transparency has no equivalent in many peer-reviewed publishing outlets.

For clinical research, the ‘open peer review’ concept is particularly relevant.  Research is rarely clear-cut, and nowhere is that more true than in clinical research.  Good study design relies on human variables being accounted for as effectively as possible, but clearly there are some facts that cannot be altered. For example, a study on COVID19 in the USA may require a different perspective to be relevant to a patient cohort in the UK, owing to our different healthcare structure and demographics. All clinical research must therefore be reviewed in that context, in addition to reviewing the methods themselves.

Preprints are also a great equaliser for researchers and the public.  Publishing and reading a pre-print are both free.  Clinicians from all over the world can share their work, access the same evidence and assess its meaning for their patients.  In addition, the general public, who often fund research directly or indirectly, and patients, who often contribute to this research, can all have access. 

There are, of course, some concerns.  A long-held anxiety has been around patient identifiable data; pre-print publishing should never be at the expense of clinical governance principles and risking patient identification.  Pre-prints place that responsibility more completely with the authors to ensure appropriate principles and procedures have been followed.  In addition, open data must be carefully considered for the same reasons, but recent work, such as a study looking at over 17 million patients in the UK, has demonstrated that this is achievable. 

The biggest worry around pre-prints for clinical research is quality control.  The power of publishing is enormous – for the researcher, because of the value placed on publishing by the academic community, and for society, because of the downstream impact on patients. Once a research paper states something is true, the time taken to debunk any falsities is enormous, particularly if it is picked up by the media.  It’s worth noting a study of the difference between perceived quality of publishing between pre-prints and peer-reviewed articles was negligible.  There must be ongoing work on how we value research output by quality over quantity, in pre-print or peer-reviewed publishing, and how pre-prints compare to their published versions. 

Some of the most important evidence around COVID19 is coming through open access outlets, including pre-prints. You can’t hold a wave back, and this new age of clinical research publishing is here to stay.  The iSearch COVID19 Portfolio is a useful search tool created and curated by the National Institute of Health, which allows you to search for publications from pubmed and several pre-print platforms.  ASAPBio has lots of information on pre-prints, and you can read more about Open Access on the SPARC website.  There is a wealth of information about how organisations like the Medical Research Council (MRC) and the Wellcome Trust support open access in the links provided.  

Dr Karin Purshouse is an ECAT Clinical Lecturer at the University of Edinburgh and Honorary Specialty Registrar in Medical Oncology at Edinburgh Cancer Centre, UK.

This post is by Dr. Karin Purshouse and is released under a Creative Commons Attribution 4.0 International license, except where otherwise indicated. Please reference OER and Beyond and use this URL when attributing this work; for more information on licensing, see our Open Access Policy.