What does this research mean for the field?

Only 60% of finalized and ongoing post-authorisation studies registered with the EMA have uploaded a protocol, and less than 70% of finalized studies have uploaded results, indicating insufficient adherence to legislation and recommendations. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

What question did this study set out to answer?

The aim is to evaluate adherence to legislation regarding the public posting of protocols and results for post-authorisation studies registered with the EMA.

March 1, 2026Open Access

Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with European Medicines Agency: cross sectional study.

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The aim is to evaluate adherence to legislation regarding the public posting of protocols and results for post-authorisation studies registered with the EMA.
Conducted a cross-sectional analysis of uploaded protocols and results
Assessed adherence rates across various post-authorisation studies
Evaluated the impact of Risk Management Plans (RMP) on adherence
Only 60% of post-authorisation studies had uploaded a protocol
Less than 70% of finalised studies posted results
Adherence was notably lower for studies not included in RMPs

Discussion

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Implication

Cross sectional study assesses adherence to posting legislation for protocols and results of studies, indicating the need for increased transparency.

Cite This Study

Ramezani et al. (2026) studied this question.

synapsesocial.com/papers/69a3d79dec16d51705d2dd04 https://doi.org/10.1136/bmj-2025-086693

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Implication

Cross sectional study assesses adherence to posting legislation for protocols and results of studies, indicating the need for increased transparency.

Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with European Medicines Agency: cross sectional study.

Key Points

Discussion

Implication

Cite This Study

Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with European Medicines Agency: cross sectional study.

Key Points

Discussion

Implication

Cite This Study

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