Member

Overall, we welcome these regulations. We see them as a crucial step towards modernising the UK’s clinical trials framework. How we need to improve our clinical trials is one of the things that I hear about from industry all the time. We have great potential here, but we get slowed down by this bottleneck. We agree with the aims to improve efficiency, to foster innovation and to enhance transparency, but at the same time we must be mindful of the concerns that have been raised by others. Do we have the proper resources? Have we looked carefully at the unintended consequences? How do we make sure that the focus is on lower risk, with the appropriate focus on higher risk, so that we can all agree with the Government’s position on clinical research? This is about maintaining essential protections for patients and data integrity, making sure that the UK is at the forefront of clinical trials and encouraging more companies to do them here while, at the same time, reassuring the public about safety. I look forward to the Minister’s response.