Why missing results are a problem for clinical trials in the EU

Why missing results are a problem for clinical trials in the EU
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Under EU clinical trials regulations, results of studies must be published within 12 months of completion or six months for trials involving children. These results are incorporated into the European Union Clinical Trials Register (EUCTR).

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Despite this, a study by the University of Oxford found that just under 52 per cent of trials have submitted their results.

This issue may even be understated, considering the 17,000 additional trials on the EUCTR that have probably been completed but have inadequate publicly-available data. Based on the anticipated duration of these trials, it is estimated that approximately 64 per cent are overdue.

There are some arguable causes for the non-disclosure of results, two of which are within an organisation’s control and two of which are in the control of regulators and registries. Why do so many organisations not comply with reporting regulations?

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Lack of reliable processes

Over 90 countries must disclose results of clinical trials to one of over 30 registries. If an organisation has not clearly documented exactly when and who they must report to, it becomes almost impossible to uphold obligations.

Failure to maintain documentation

An organisation that undertakes numerous studies, such as an academic organisation, may not adequately maintain records, making it tough to monitor deadlines.

When a company undertakes a merger, acquisition or divestiture, it can be particularly difficult to keep track of who is responsible for what.

This failure to maintain comprehensive information can cause abandoned trials and add to the issue of trials registered with incorrect or insufficient information; furthermore, you cannot search for adaptive phase 1 studies on the EUCTR, which are completed by organisations such as https://www.richmondpharmacology.com/specialist-services/adaptive-phase-i-studies, unless they have child participants. This means it is the organisation conducting the study’s responsibility to maintain accurate records.

Restrictions on updating

On registries including the EUCTR, certain data can only be updated by local health authorities, causing delays. Studies show that approximately two-thirds of trials identified as inconsistent have reported their results but the records have not been sufficiently updated.

Legal non-disclosure

In some circumstances, results cannot be disclosed due to conflicting regulations or privacy laws. Unfortunately, the EUCTR does not allow organisations to clarify why results have not been made available, causing the appearance of non-compliance.

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