This year, metadata development is one of our key priorities and we’re making a start with the release of version 5.4.0 of our input schema with some long-awaited changes. This is the first in what will be a series of metadata schema updates.
What is in this update?
Publication typing for citations
This is fairly simple; we’ve added a ‘type’ attribute to the citations members supply. This means you can identify a journal article citation as a journal article, but more importantly, you can identify a dataset, software, blog post, or other citation that may not have an identifier assigned to it. This makes it easier for the many thousands of metadata users to connect these citations to identifiers. We know many publishers, particularly journal publishers, do collect this information already and will consider making this change to deposit citation types with their records.
Every year we release metadata for the full corpus of records registered with us, which can be downloaded for free in a single compressed file. This is one way in which we fulfil our mission to make metadata freely and widely available. By including the metadata of over 165 million research outputs from over 20,000 members worldwide and making them available in a standard format, we streamline access to metadata about scholarly objects such as journal articles, books, conference papers, preprints, research grants, standards, datasets, reports, blogs, and more.
Today, we’re delighted to let you know that Crossref members can now use ROR IDs to identify funders in any place where you currently use Funder IDs in your metadata. Funder IDs remain available, but this change allows publishers, service providers, and funders to streamline workflows and introduce efficiencies by using a single open identifier for both researcher affiliations and funding organizations.
As you probably know, the Research Organization Registry (ROR) is a global, community-led, carefully curated registry of open persistent identifiers for research organisations, including funding organisations. It’s a joint initiative led by the California Digital Library, Datacite and Crossref launched in 2019 that fulfills the long-standing need for an open organisation identifier.
We began our Global Equitable Membership (GEM) Program to provide greater membership equitability and accessibility to organizations in the world’s least economically advantaged countries. Eligibility for the program is based on a member’s country; our list of countries is predominantly based on the International Development Association (IDA). Eligible members pay no membership or content registration fees. The list undergoes periodic reviews, as countries may be added or removed over time as economic situations change.
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.