New guidance looks to streamline safety assessment process.
Lovers of European Union minutiae of clinical trials regulation have a feast to digest before the end of January. That is when a new rule comes into effect with the snappy title of "Commission Implementing Regulation (EU) 2022/20 of Jan 7, 2020 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials.
Those who like to work only from primary source can check out verbatim the just-published–and rebarbatively-phrased–rule. Those who would prefer a quick overview, this is the place for you, because your columnist has benefited from a comment by Silvia Garcia, who is senior manager for science policy, regulatory and drug development at the European drug industry federation, EFPIA, and who is particularly involved in clinical trials and pharmacovigilance.
According to Garcia, the main thrust of the new rule is to establish how the EU's member states are to work together and organize themselves in order to avoid duplication of work in these safety assessments. Some double-handling has been happening until now, since the national competent authority or ethics committee in each country has assessed safety reports on its own.
Under the new dispensation, there will be a lead member state in each case, and the safety assessment will be handled in a more coordinated way. With the EU's new clinical trial information system also coming into operation at the end of January, there will be one central submission for all studies concerned with the same investigational medicinal product–which will replace the current frequent practice of a dozen or more assessments in parallel by different countries where studies with the same IMP are running
Garcia and her staff have added a little more guidance on the technical changes, including the novelty of "saMS" that the new rules create–which denotes a "safety assessing member state," a formal concept that did not exist in EU rules until now. What this means in effect is that the saMS will handle the assessment of a suspected unexpected serious adverse reaction report in a more coordinated fashion, with one central submission of a development safety update report per IMP via CTIS for all studies concerned, and one centralized assessment of that DSUR instead of a dozen parallel assessments in different countries where studies with that IMP are running.
The work-sharing concept of the new rule has been compared to procedures for periodic safety update report single assessment (or PSUSA for the cognoscenti) in the post-marketing setting. In addition, the rule defines the process and timelines for a regular assessment of submitted SUSARs, which could bring some advantages, say those who are close to these processes.
The EU itself says in its new rule that it "should strengthen participants’ safety in clinical trials and contribute to improved data robustness regarding the safety profile of investigational medicinal products and their corresponding active substances."
Against the background of the implementation of CTIS later this month, with all the changes implied for the entire clinical trials community in Europe and beyond, the introduction of saMS is of course a drop in the ocean. But then, everyone is already totally prepared for CTIS–aren't they?