Advice for Management of Clinical trials in relation to Coronavirus has been published on the MHRA Inspectorate blog. MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.
The following information has also been released by Stephen Wright, Clinical Director – Research at NUTH:
I am aware the situation with regard to Coronavirus disease (COVID-19) is changing rapidly and there is a need to establish good lines of communication with the research teams and principal investigators. This is a preliminary email to reassure you that we are working closely with the senior leadership team overseeing the Trust’s response to the pandemic and have plans in place to respond quickly, as the situation develops. Over the coming weeks, it is likely that we will see significant demands placed on our clinical services and inevitably this will impact on clinical research in the organisation. We will need to manage these demands to ensure staff and patient safety and to maintain the high standards of trial conduct and governance that we achieve in Newcastle. In line with the Trust’s current advice to clinical directorates we would like you all to consider the following points:
1. Please follow all Trust guidance with regard to PPE, COVID-19 testing and patient management.
2. Consider which of your current research studies would need to continue, for example where a patient’s treatment depended on them being in the trial or where the study is investigating COVID-19.
3. Consider which of the current studies could be put on hold, with a pause in recruitment but ongoing follow up of enrolled participants. You may wish to begin conversations with sponsors regarding this but continue as normal for now.
4. Review the follow up arrangements for current studies and explore whether follow up could be done by telephone or by video-conference.
5. Consider whether it is sensible to open a new study at the moment, especially one that would require patients to attend hospital over the coming months.
6. There may be requests for nurses and AHPs in the research delivery teams to help support clinical services and we would be grateful if you would consider volunteering as required.
Wherever possible, please maintain business as usual for clinical research in the Trust but bearing in mind the above points. These are extraordinary times and further, more detailed, advice and information will follow in the coming days.
Thank you. Best wishes.”
Clinical Director – Research