COVID-19 has had a significant impact on the conduct of clinical trials and participants. Participants in cardiovascular (CV) trials typically are older, with underlying CV disease or risk factors such as hypertension and diabetes – a population at higher risk of death from COVID-19 if they contract the virus. As a result, these individuals may have heightened concerns about participating in a clinical trial due to the potential for exposure to COVID-19.

To mitigate these issues, our whitepaper outlines measures that can be implemented in ongoing trials assessing CV-directed therapies to ensure the safety of participants, maximise retention and maintain trial integrity, including:

• Conducting a study- and site-level risk assessment
• Integrating cardiovascular mHealth and telehealth technologies
• Reducing missed and out-of-window study visits and minimising trial disruption through home health and remote monitoring tools
• Updating the CRF to capture protocol modifications and documenting COVID-19 related deviations
• Maintaining regular site communications and document compliance