As well as supporting recruitment into clinical trials, Genomics England is looking to facilitate research in the UK in other ways. Currently, data are only available to researchers through application to the National Genomics Service; however, plans are underway for open access to data for continued follow up and future recall for research and clinical trials.
Andrew Foxley (Astra Zeneca) shared his view of the challenges and opportunities provided by the potential ‘golden age’ of drug development that is tantalisingly within our grasp. There are a number of key drivers that have led us to the current position: an increasingly ageing population, technology informing patients of what they may be missing out on, rapid advances in science and technology, and the balancing of science with sustainability in terms of the size of highly selected populations.
He stressed that the right infrastructure will need to be in place to deliver on this promise, particularly in relation to clinical trials:
- Reconsidering the definition of endpoints in the era of early disease detection and early treatment to delay progression.
- Moving beyond the eCRF to increase the speed of data acquisition through technology.
- Global harmonisation of the regulatory and ethical framework.
The UK is in a strong position to lead on this, with a stable patient population suitable for long term follow up, strong academic and industry partnerships, a focus on science and a world-leading regulator. Opportunities include automated data extraction and analysis, and data linkage and use of real-world evidence to study patients in routine clinical settings.
Andrew echoed the view of many of the conference speakers - the opportunity is here, it is now and it needs to be grasped as a matter of urgency - all stakeholders will need to work together to realise this including MHRA, NHS Digital, HTA bodies, the life sciences industry and most importantly, patients. The Life Sciences Industrial Strategy has already led to a second sector deal and is considered to be the best prepared sector in the face of a potential Brexit.