Revisions to rules on the publication of clinical trial information will make it easier for people to access drug studies according to the EMA.
The European Union (EU) regulator, which formally adopted the revised transparency rules last week, predicted they would “give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way.”
One change is the removal of the deferral mechanism that let sponsors delay publication of certain data and documents for seven years after the end of the trial to protect personal data and commercially confidential information (CCI).
The European Medicines Agency (EMA) said the revision strikes a balance between transparency and protection of commercial information, adding it also benefits patients because key trial data will be published earlier than under the previous rules.
In addition, according to the agency, the revision simplifies processes covering the protection of personal data.
The EMA also suggested the rules changes would aid clinical trial staff, explaining “they benefit healthcare professionals because the resulting system is more user-friendly,” citing access to enrolment information as an example.
Effective date
The revision replaces transparency rules implemented in the CTIS at the time of the launch in January 2022, which were defined in a document adopted by the EMA in 2015.
The revised rules will apply after their technical implementation in CTIS, including its public portal, which is expected to be finalized in the second quarter of 2024.
The agency added that “The effective date of completion of the process and the entry into application of the new rules will be communicated to the users of the system before they become applicable.”
The revision was prompted by feedback the EMA received from stakeholders as well as experience after the launch of the system and an eight-week public consultation that was held between May and June.
DepositPhotos/g0d4ather