Expert Position Paper on conducting HF clinical trials in the COVID-19 era
Recently, the Heart Failure Association of the ESC has published an Expert Position Paper in the European Heart Journal. Expert clinical trialist of this special group of the ESC have gathered in web-based meetings resulting in a position paper.
Although many regulatory authorities from different world regions have issued guidance on how to conduct clinical trials in COVID-19 times, there may be a need for recommendations for international trials. This paper may supplement local advice and regulations. Challenges that arise during the COVID-19 pandemic to conduct clinical trials in HF are highlighted and advice is offered how to overcome these. The discussions and recommendations focus on HF clinical trials, but may be extrapolated to other therapeutic areas.
The COVID-19 pandemic has large implications for participants in clinical trials, the staff caring for these patients and eventually for the trials. Safety and effective care should be ensured to trial participants without affecting the integrity of the trial. HF patients may be at greater risk of infection and outcomes of COVID-19 may be worse in these patients. On the other hand, if regular clinical care is compromised they are at risk of adverse outcomes.