European regulators published a question and answer document that they hope will give more clarity on how complex clinical trials (CCT) should be conducted. The document aims to answer some basic questions, such as what to consider in the planning and conduct of CCTs, how to justify Bayesian approaches to regulators, and how to use biomarkers.
On 2 June, the European Commission (EC), European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published a joint Q&A intended to provide guidance on CCTs. They note that the structure of the results from a CCT in a marketing authorization (MAA) may differ significantly from its submission(s) for clinical trial authorization (CTA). For example, the regulators write, “A MAA submission that is based on an active and a control arm which had been submitted as different CTAs yet were part of a shared scientific framework,” noting that a CCT may refer to a trial within a single EU clinical trial number or to multiple related trials with different EUCT numbers under the same master protocol.
