Last 29 September, the EU Commission issued a new version (6.6) of the Q&A regarding Regulation (EU) 536/14, better known as the Clinical Trials Regulation (CTR). This updated version of the Q&A includes 3 important new features and is part of Volume 10 ("Clinical Trial Guideline") of EudraLex, the collection of rules and regulations concerning medicinal products in the European Union.
The following are the 3 main changes mentioned above:
- Question 2.8: In paragraph 102, as now proposed, it is clarified how a clinical trial can’t be started until the relevant application has been evaluated and a risk-benefit balance is positively seen at the time of authorization. The updated Q&A adds that "exceptionally, the sponsor must first fulfil a condition within a defined deadline described in the condition text, e.g, in an approved substantial modification application, which could mean that the start of the trial or the inclusion of the first subject is delayed until the condition is met";
- Question 7.51: Represents an entirely new question and is intended to clarify how the sponsor - although the CTR does not specify any documentation of exposure to ionizing radiation in clinical trials - is required to include information on exposure to ionizing radiation in the protocol in line with CTR Annex I, Section D, in order to allow for appropriate assessments of the benefits and risks of the clinical trial. The specific information to be included depends on whether the procedures involved are radiodiagnostic (i.e., radiology and nuclear medicine) or radiotherapeutic (i.e., external beam radiotherapy, brachytherapy, and systemic radiotherapy with radiopharmaceuticals). The updated Q&A describe the principles and evaluation criteria applicable to both types of procedures and emphasize that any deviation from the principles described must be justified in the protocol to assess the benefits and risks;
- Question 9.4; The answer to this question provides clarification regarding the scenarios in which a patient, who was a minor at the time of enrollment, becomes an adult during the course of the clinical trial. Upon the occurrence of this circumstance, the minor patient who reaches the age of legal competence (as determined by each national law), will have to give informed consent for the purpose of continued participation in the study. In this regard, the person who has reached the age of majority, should sign the appropriate consent form after being properly informed, in line with the requirements of the Clinical Trial Regulations.