Member

We know that these measures will introduce greater flexibility and accommodate innovative trial designs. Noble Lords know that a one-size-fits-all approach is not appropriate; it is absolutely right that we are as flexible as possible. We will now see guidance, rather than rigid legislative details, used for specific requirements, which will allow researchers to tailor their trials to suit the needs of the study and the risks involved. Once again, that all makes complete sense on the surface, and we welcome it, but how do we avoid a situation where the lack of clear legislative requirements could lead to inconsistencies in trial design? We want flexibility, of course—these things should not all be the same—but, in having that, will this measure introduce some inconsistencies and perhaps complicate regulatory oversight? It is welcome but, once again, let us look out for unintended consequences. If flexibility is not managed, would it lead to varying standards across trials, thus creating gaps in safety and quality assurance? What is the intention to avoid that?