Our colleague and friend, Kirsty Meddings, passed away peacefully on 10th December at home with her family, after a sudden and aggressive cancer. She was a huge part of Crossref, our culture, and our lives for the last twelve years.
Kirsty Meddings is a name that almost everyone in scholarly publishing knows; she was part of a generation of Oxford women in publishing technology who have progressed through the industry, adapted to its changes, spotted new opportunities, and supported each other throughout.
Crossref has supported depositing metadata for preprints since 2016 and peer reviews since 2018. Now we are putting the two together, in fact we will permit peer reviews to be registered for any content type.
2020 has been a very challenging year, and we can all agree that everyone needs a break. Crossref will be providing very limited technical and membership support from 21st December to 3rd January to allow our staff to rest and recharge. We’ll be back on January 4th raring to answer your questions. Amanda explains more about why we made this decision.
On November 11th 2020, the Crossref Board voted to adopt the “Principles of Open Scholarly Infrastructure” (POSI). POSI is a list of sixteen commitments that will now guide the board, staff, and Crossref’s development as an organisation into the future. It is an important public statement to make in Crossref’s twentieth anniversary year. Crossref has followed principles since its founding, and meets most of the POSI, but publicly committing to a codified and measurable set of principles is a big step. If 2019 was a reflective turning point, and mid-2020 was about Crossref committing to open scholarly infrastructure and collaboration, this is now announcing a very deliberate path. And we’re just a little bit giddy about it.
It’s here. After years of hard work and with a huge cast of characters involved, I am delighted to announce that you will now be able to instantly link to all published articles related to an individual clinical trial through the Crossmark dialogue box. Linked Clinical Trials are here!
In practice, this means that anyone reading an article will be able to pull a list of both clinical trials relating to that article and all other articles related to those clinical trials – be it the protocol, statistical analysis plan, results articles or others – all at the click of a button.
Linked Clinical Trials interface
Now I’m sure you’ll agree that this sounds nifty. It’s definitely a ‘nice-to-have’. But why was it worth all the effort? Well, simply put: “to move a mountain, you begin by carrying away the small stones”.
Science communication in its current form is an anachronism, or at the very least somewhat redundant.
You may have read about the ‘crisis in reproducibility’. Good science, at its heart, should be testable, falsifiable and reproducible, but an historical over-emphasis on results has led to a huge number of problems that seriously undermine the integrity of the scientific literature.
Issues such as publication bias, selective reporting of outcome and analyses, hypothesising after the results are known (HARKing) and p-hacking are widespread, and can seriously distort the literature base (unless anyone seriously considers Nicholas Cage to be causally related to people drowning in swimming pools).
This is, of course, nothing new. Calls for prospective registration of clinical trials date back to the 1980s and it is now becoming increasingly commonplace, recognising that the quality of research lies in the questions it asks and the methods it uses, not the results observed.
Uptake of trial registration year-on-year since 2000
Building on this, a number of journals and funders – starting with BioMed Central’s Trialsover 10 years ago – have also pushed for the prospective publication of a study’s protocol and, more recently, statistical analysis plan. The idea that null and non-confirmatory results have value and should be published has also gained increasing support.
Over the last ten years, there has been a general trend towards increasing transparency. So what is the problem? Well, to borrow an analogy from Jeremy Grimshaw, co-Editor-in-Chief of Trials – we’ve gone from Miró to Pollock.
Although a results paper may reference a published study protocol, there is nothing to link that report to subsequent published articles; and no link from the protocol itself to the results article.
A single clinical trial can result in multiple publications: the study protocol and traditional results paper or papers, as well as commentaries, secondary analyses and, eventually, systematic reviews, among others, many published in different journals, years apart. This situation is further complicated by an ever-growing body of literature.
Researchers need access to all of these articles if they are to reliably evaluate bias or selective reporting in a research object, but – as any systematic reviewer can tell you – actually finding them all is like looking for a needle in a haystack. When you don’t know how many needles there are. With the haystack still growing.
That’s where we come in. The advent of trial registration means that there is a unique identifier associated with every clinical trial, at the study-level, rather than the article level. Building on this, the Linked Clinical Trials project set out to connect all articles relating to an individual trial together using its trial registration number (TRN).
By adapting the existing Crossmark standard, we have captured additional metadata about an article, namely the TRN and the trial registry, with this information then associated with the article’s DOI on publication. This means that you will be able to pull all articles related to an individual clinical trial from the Crossmark dialogue box on any relevant article.
This obviously has huge implications for the way science is reported and used. By quickly and easily linking to related published articles, it will enable editors, reviewers and researchers to evaluate any selective reporting in the study, and help to provide far greater context for the results.
As all the metadata will be open access (CC0), with no copyright, it will also be possible to access this article ‘thread’ through the Crossref Metadata Search, or independently through an application programming interface (API). This provides a platform for others to build on, with many already looking to take the next step, such as Ben Goldacre’s new Open Trials initiative.
However, in order for this to work, we must capture as many articles and trials as possible to create a truly comprehensive thread of publications. We currently have data from the NIHR Libraries, PLoS and, of course, BioMed Central, but need more publishers and journals to join us in depositing clinical trial metadata. After all, without metadata, this is all merely wishful thinking.
Let’s hope we’re the pebble that starts the landslide.
