NRA approval and Trial Site
- A key bottleneck during clinical development is attaining National Regulatory Approval (NRA). Is can be especially difficult in the context of an international trial, where local rules may differ from country to country, or the NRA itself may have insufficient experience and seek expert opinions, which again can delay the process. Engagement with the NRA at an early stage is essential in order to minimise delays and getting an early opinion on trial design and its requirements is key to this.
- Working with credible and experienced partners will also help to minimise delay and several clinical trial networks already exists to facilitate clinical development. In the UK, both the NHS NIHR (National Institute for Health Research) and the MRC have established clinical trials networks that may be able to assist. Internationally, there are EU wide and US trial networks, some of which are pathogen specific, that can also bridge this bottleneck.