The Medicines and Healthcare Regulatory Agency (MHRA) have offered advice on the management of clinical trials during the coronavirus outbreak in the UK.
The conduct of clinical trials is being adversely affected by the recent coronavirus pandemic. People are being advised to avoid hospitals, GP surgeries and areas of high density. Some have also been advised to self-isolate, therefore cannot participate in required clinical trial activities. Furthermore, many clinical trial staff are working from home. Hence, there have been many reports of protocol and standard operating procedure (SOP) deviations due to lack of patient attendance and alteration of processes, such as posting drugs out to patients. Wet-ink signatures have been difficult to obtain as staff are working from home.
All of these changes can increase deviations in clinical trials, delaying the application and evaluation process. The MHRA have issued a warning stating that sponsors should ensure any protocol deviations are well documented in order to enable efficient and appropriate evaluation of trials. However, unless patients are being put at risk, there is no need to report an increase in deviations if they are due to the coronavirus.
As there is a constant re-adjustment of staff, monitoring and quality assurance activities should be re-assessed to ensure continuous patient well-being. The MHRA advises brief risk assessment and documentation. If the safety of a trial subject is compromised because they cannot meet key evaluation criteria or align to critical mitigation steps, discontinuation of the subject should be considered. Sponsors should also highly consider the risk v benefit of immunosuppressant clinical trials, as these could pose an increased risk of infection with the coronavirus.
The MHRA have also stated that email confirmations can be considered an alternative method of demonstrating approvals if wet-ink signatures are not possible, as long as the deviation is well documented.
For detailed advice from the MHRA regarding clinical trials during the coronavirus pandemic, click here.