Case study: The ISRCTN registry of clinical trials at Springer (BioMed Central)
BioMed Central is an STM (Science, Technology and Medicine) publisher of over 280 peer-reviewed open access journals. The portfolio of journals spans all areas of biology, biomedicine and medicine and includes broad interest titles, alongside specialist journals. BioMed Central is owned by Springer Science+Business Media.
Openness and transparency are increasingly important drivers for researchers to register their clinical trials. The ISRCTN registry, which is hosted and administered by BioMed Central on behalf of ISRCTN, provides an important service in this respect and is recognised by international regulatory bodies. At the start of the project the ISRCTN website was in need of an update. The site was over 10 years old and it was difficult for researchers to submit trial details. Editors had no automatic way of reminding researchers that they had to complete their submissions or reply to editorial queries. Payments were made offline and the administration for this aspect of the service was time-consuming.
As a trusted information product development partner for Springer, 67 Bricks were asked to redevelop the ISRCTN registry system. The project benefited from our collaborative approach to developing digital products: we worked closely with internal stakeholders throughout the project to understand and prioritise business objectives, and to respond to users' needs. The work was carried out in monthly iterations. A showcase of each month's work allowed stakeholders to feed back on the work and adjust requirements if necessary.
The project focused on delivering a greatly improved user experience for all three key groups of users - general visitors to the site, researchers submitting online details about their studies, and the editorial team who perform quality control on the submissions:
For the public, the site has a much cleaner look and, importantly, a much better search. Search functionality is facilitated through the underlying MarkLogic database. A simple search with facets for filtering search results by any of four key criteria was introduced; the chosen facets being: Condition, Country of recruitment, Trial status and Age range of participants. A straightforward to use but powerful advanced search option allowing Boolean searching across many data fields was also included. Discoverability is further aided by the routine assignment of DOIs. The registry is also included in the CrossMark service from CrossRef.
For researchers, the trial registration process is much clearer (Figure 1). Researchers are guided through their submission with the use of information panels, examples, and dropdown menus for relevant fields at appropriate points during inputting. Importantly, they are able to save partially completed submissions rather than having to complete them in one session. The option for researchers to pay for their trial submission by credit card was introduced alongside the existing invoicing mechanism, and this has had a large uptake.
For editors, a simple workflow process was introduced to support them in validating new submissions, raising queries with the trialist, reviewing and approving for registration. This included a series of automated emails to chase for a response when overdue.
Figure 1: the trial registration page
The site can be viewed at www.isrctn.com
Since the site went live in late 2014 the monthly submission rate has increased by approximately 15% compared to the same months in the previous year, and the average time to publication has almost halved, indicating that the service to researchers has significantly improved. Additionally, over half the payments are now by credit card, reducing administrative overheads for both the researchers and BioMed Central.
The editorial team is able to focus on adding value to submissions rather than performing repetitive clerical tasks to compensate for the limited support given by the old system. This is leading to a better quality product and thus helping to enhance its reputation and supporting the drive towards openness and transparency in clinical trials research.
"The ISRCTN registry looks modern and professional and the new website has been very well received. When selected, the online payment option is very efficient and ensures fast registration for researchers. The search functionality has also been greatly improved which allows ISRCTN to compare favourably with other registries. On top of developing a more robust editorial system, 67 Bricks have been available to advise on how best to query the underlying database in order to track performance and produce relevant metrics, which is most valuable when you move to a new system."
Helene Faure, Database Manager, ISRCTN.
"I was very pleased to find the new ISRCTN website so much simpler and easier to follow. It is much easier to navigate and use whether you are registering a new trial or just generally viewing information about registered trials. The Government is committed to making sure that patients are able to find out about clinical trials that may be of interest to them and the new website fully supports this, as well as ensuring that the Government's policy of transparency in research is further implemented."
Justin Riordan-Jones, R&D Information Manager at Department of Health (UK).