Fit for the future: empowering clinical trials with digital technology

Digital innovation and the increasing ability for easier application are transforming our daily lives. This transformation is being driven by rapid changes in technology but also consumerism. Whilst there is a clear opportunity to apply these innovations to clinical research, advances here have been much slower. There is a need for relevant stakeholders to embrace digital innovation and to balance it with research governance, security of patient information, trustworthiness, and a social license to use these techniques in health research.1 Changes are required to rapidly accelerate advancements in cardiovascular diseases (and reverse withdrawal of industry investment), based on more efficient cardiovascular outcome trials which remain the bedrock of our discipline. In this viewpoint, we highlight the need for a paradigm change to reinitialize large-scale pragmatic cardiovascular trials. A modern clinical trials pipeline can use digital methods to improve screening and recruitment of participants, the processes within trials, and the ascertainment of outcomes. Patient and public involvement in the design and running of trials can enhance relevance, quality and output.2 Without an attempt towards structured change, the increasing burden of administration and high cost3 will render future large-scale evidence generation unfeasible or restricted to narrow commercial interest. Digital innovation is already helping to fill major evidence gaps and empower stakeholders to deliver new, clinically relevant trials within the healthcare settin