The European Medicines Agency (EMA), along with the European Commission and the Member States of the European Union (EU), has proposed changes in guidelines for first-in-human clinical trials.
The changes in guidelines are intended to improve the safety of the volunteers participating in the trials.
EMA recently released a concept paper seeking public consultation on the revisions to be made on the existing guidelines.
The proposition has been taken to accommodate the evolving clinical practices in the last ten years, as well as take into account the incident occurring in the phase I first-in-human clinical trial in France in January, which claimed one person and hospitalised five subjects.
The guidance is primarily focused on non-clinical aspects, such as the better integration of pharmacokinetic along with pharmacodynamic data and toxicological testing into the overall risk assessment, as well as the role of non-clinical data in the definition of the estimated therapeutic dose, maximal dose, and dose steps and intervals.
It also stresses clinical aspects such as criteria to stop a study, the rolling review of emerging data with special reference to safety information for trial participants, and the handling of adverse events in relation to stopping rules and rules guiding progress to the next dosing level.
EMA is aiming to publish the final revised guideline to conduct first-in-human clinical trials early next year.