EC Explains What it Means to Authorize Clinical Trials With Conditions
For the second time in less than a month, the European Commission (EC) has updated its questions and answers (Q&As) document on the incoming clinical trials regulation, this time explaining what it means to have a trial authorized subject to conditions.The Q&A makes clear upfront that an initial clinical trial application, substantial amendment or an addition of a member state concerned can be authorized, authorized subject to conditions or rejected.
For this nebulous “subject to conditions” category, the EC explains that such authorizations are “restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.” And setting a condition is “only possible in case of an application with a positive benefit/risk balance. This means that if the benefit-risk balance is not positive at the time of the authorisation, the application should be rejected.”
Such conditions can include a “request additional data not available at the time of the authorisation, e.g. data needed for later trial parts, but not preventing the start of the trial,” or to “indicate aspects that the sponsor need to fulfill after the authorisation, e.g. submission of minutes of the safety data monitoring board meetings.”
The Q&A notes that such conditions are to be included in the respective conclusion section of the EU Portal/database (CTIS) by the reporting or concerned member state, as well as in the assessment report.
“Conditions should be clear and related to an issue already identified in the request for information (RFI) submitted during the assessment. Usually a single round of RFI is expected with a short time for providing an answer. All critical issues raised in the RFI are expected to be solved in the answer to it, including submission of the corresponding updated documents (e.g. protocol, Investigator`s Brochure or IMPD), when the answer imply changes for them (reference to Q&A on RFI). Therefore, CT applications for authorisation should be complete from the initial submission in order to maximize the chance for approval,” the EC adds.
In addition to this new Q&A on trials authorized with conditions, the updated Q&A also features revisions on whether studies involving the administration of a medicinal product when the object of the investigation is not the administered medicinal product, but exclusively the physiology of the body, should be considered clinical trials (answer: no), and how responsibilities are shared in case a clinical trial has more than one sponsor.
The previous update last month also included new Q&As on RFIs, how assessment reports will be made public and the sponsor’s responsibilities regarding changes to a clinical trial that are not substantial modifications but are relevant for supervising a trial.
CLINICAL TRIALS REGULATION (EU) NO 536/2014 DRAFT QUESTIONS & ANSWERS VERSION 2.3