As clinical trial registries struggle to adopt new functions, the UK registry calls for support

The ISRCTN clinical trial registry is calling for users to review its prototype for submitting study results in a structured format. This is an excellent opportunity for UK researchers to shape a system that they will have to use for many years to come. Meanwhile, other registries worldwide will struggle to meet the same standards.

As ISRCTN put it in a recent post:

“Do you ever find yourself saying – ‘Why does this app do that – it would be much better if….’ Well now you have the opportunity to voice your feedback… BEFORE we go into production in early September.”

“If you are a clinical study researcher in the UK providing your feedback now could save you time and frustration when it comes to submitting your results in the future.”

According to ISRCTN, the prototype system aims to meet new WHO requirements for trial registries and at the same time:

1. Make results submission as easy as possible

2. Provide flexibility for different study designs

3. Help researchers submit accurate and complete data

4. Make it easy to access and re-use results

ISRCTN has a well-deserved reputation for being user-friendly. Let’s keep it that way.

You can get involved in the design process by contacting ISRCTN either on LinkedIn or by email and asking them to share their templates with you.

NEW WHO RULES

In future, the WHO will require all registries within its global network to adopt structured, ‘tabular’ formats for trial reporting.

To date, most registries worldwide capture results only in the form of hyperlinks to journal publications or free-form PDF uploads.

Tabular results have multiple important advantages. They overcome the slow speed of academic publishing, address rampant outcome switching and other widespread quality problems in journals, and provide outcomes in a structured machine-readable format.

TRIALS AND TRIBULATIONS

 

Users of registries that already require such formats have often struggled to upload results onto them:

• The old European EudraCT was a nightmare to navigate until the European Medicines Agency started actively supporting researchers with manuals and a helpdesk.

• The long-established American ClinicalTrials.gov is easier to use, but uploading the results of unconventional trials – such as platform trials – continues to be a challenge.

WHAT’S UP WITH EUROPE’S CTIS REGISTRY?

The European Union’s recently launched CTIS registry for drug trials currently only allows trial results to be uploaded in PDF format. However, in future CTIS too will require users to upload results in a structured format.

According to the press office of the European Medicines Agency:

“Tabular summary results reporting in CTIS, i.e. submission of results as structured data instead of document uploads, is foreseen to be implemented based on the finalisation of ICH M11 on standardised protocol elements (which also impact results submission) and the subsequent development of CTIS. EMA is working on this feature and will share updates as they become available.”

MULTIPLE REGISTRY DISASTERS AHEAD?

According to a former registry manager, setting up and managing a structured results reporting system is by far the most challenging task a registry can undertake.

The UK’s ISRCTN registry charges a modest user fee and thus is financially sustainable.

However, the global network of trial registries includes some players with very limited or insecure funding, such as the Pan-African Trial Registry and the Lebanese Trial Registry. In the past, the Thai registry has gone dormant for months because its money ran out, and even India’s registry came close to having to cease operations.

It is unclear how the managers of already desperately overstretched and cash-strapped trial registries are supposed to cope with an even higher workload. To date, the WHO does not seem to have offered any technical or financial assistance to help them meet its new requirements.

Moreover, the number of registries worldwide may grow even further. Researchers in many countries currently rely exclusively on the American ClinicalTrials.gov to register and report their trials for free. Whether the Trump administration will continue to indefinitely bankroll this global public good (which hugely benefits American taxpayers and patients) is unknown.

Any restrictions on global access to ClinicalTrials.gov are likely to lead to the spawning of even more registries. Researchers in Canada have already floated the idea of setting up a national Canadian registry to hedge against the risk of suddenly getting locked out of ClinicalTrials.gov.

TranspariMED has in the past suggested that the WHO develop a “plug in and play” reporting module that any registry could choose to integrate into its existing software platform, but this suggestion appears not to have been taken up.