Within the context of the Clinical Trial Regulation, there is an essential emphasis on transparency. It is imperative that sponsors recognize their obligations concerning data transparency for trials executed in the EU, specifically those concluding under the Clinical Trial Directive (CTD).

Sponsors are obligated to ensure that results from such studies are submitted to the EudraCT database. Although EudraCT is set to be superseded by the Clinical Trial Information System (CTIS), it will remain available for the submission of trial result summaries beyond January 30, 2025. This requirement, in force since 2014, mandates that sponsors post results within 6 or 12 months of the trial’s conclusion, contingent on the trial type.

Transition from EudraCT to CTIS

Trials authorized under the CTD with at least one active site in the EU after January 30, 2025, must have their results transitioned to CTIS promptly. It is the responsibility of the legal representative to ensure this data is completed, serving as a reminder to meet all trial data obligations. The European Medicines Agency (EMA) has underscored the urgency of fulfilling these data transition obligations.

Implications of Non-compliance in Data Posting

While the EMA’s stance on penalizing companies that fail to publish data from trials completed before the transition is uncertain, it remains a possibility. The U.S. FDA has already commenced fining sponsors for non-compliance with reporting requirements. It is crucial for sponsors to understand their obligation to report trial summary results.

An often overlooked but significant consequence of failing to publish results is the potential inability to utilize reference data from such trials in future Marketing Authorisation Applications. Data from clinical trials completed before the final transition date but not posted to EudraCT may not be considered admissible in future endeavors.

Moreover, maintaining a positive relationship with health authorities is paramount for sponsors. Since compliance with trial result posting requirements is mandatory in the EU, it is advisable to adhere to these obligations to foster good relations with regulatory bodies.

“While it remains to be seen whether EMA will penalize companies that fail to publish data from trials completed before the transition, it can’t be ruled out.”