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Improving clinical trial data on registries: lessons from Europe

The pandemic highlighted the dysfunctionalities of the global clinical trial registry system. Researchers and public health agencies were largely flying blind as they tried to discover effective treatments for Covid because registry data was often inaccurate and out of date, and trial results were not rapidly made available.

As a result, everyone lost out: patients received treatments based on patchy evidence, researchers wasted time repeating the same studies dozens of times, and taxpayers picked up what is probably the world’s largest ever bill for medical research waste.

The European trial registry EudraCT provides an excellent case study of what can go wrong with trial registries – but also what can be improved, often at minimal cost.

This report by Health Action International and TranspariMED discusses EudraCT’s failures, corrective actions taken, and successes, and elicits lessons learnt that are relevant to other trial registries and databases such as EUDAMED.

Ten lessons learned

Lessons learned:

1. Integrate public performance dashboards

2. Adopt automatic data integrity safeguards

3. Normalise all names

4. Integrate automated reminder functions

5. Enable ‘closing out’ of all files

6. Harmonise data across countries

7. Clearly assign responsibilities

8. Engage with small data providers

9. Instil a compliance culture from the outset

10. Actively support compliance from the outset

Read the report online or download it here:

Note: This report was originally completed in September 2021, so the performance data it cites are more than a year out of date. EudraCT data quality and quantity have considerably improved over the past year.

EMA has already implemented some of recommended measures with the new European CTIS trial registry; for example, CTIS normalises sponsor names and EMA is engaging intensively with data providers to make sure they understand and can work with the new platform. ICTRP


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