**Clinical Workshop** Contributors: Sarah Danson (Sheffield), Fiona Collinson (Leeds) and Yvette Drew (Newcastle) During the unprecedented times of the first wave of the COVID-19 pandemic, the whole world had to adapt to new circumstances. Below we summarise the ways in which ECMC members across England altered their management of clinical trials to cope with these new pressures. We describe key learning points and considerations for the second wave of the pandemic and beyond. • Challenges during Covid-19 first wave: how many and which trials to keep open (risks vs. benefits)? - Benefits: Patient benefit on a trial treatment & Holistic needs/palliative care - Risks: Travel restrictions, Staff sickness, patients shielding, lack of support services • Newcastle ECMC was the only one that stayed open during first lockdown • Phase 1 trial delivery changed: - Trial bloods taken locally - Remote monitoring - Oral IMP courier delivery - Electronic patient records - Telephone consultations - PK days reduced COVID-19 testing strategies: ![enter image description here][1] • The panel acknowledged that there is no Government guidance on COVID-19 testing strategies for patients receiving anti-cancer therapy • They agreed that a co-ordinated policy on testing among the ECMC would be useful to improve patient safety and reassure trial Sponsors Telemedicine: - Telemedicine was effective and popular with patients during the first wave of COVID-19 - Some ECMC centres are receiving requests from Sponsors to revert back to more frequent face-to-face monitoring, which is not always popular with patients given the ongoing second wave - Many patients are also keen to avoid travel outside their own region where possible - ECMC discussions with the NIHR, ABPI, CRUK and commercial sponsors about how to implement and improve remote trial monitoring are ongoing, although the panel acknowledge that some face-to-face contact will always be required, particularly when assessing fitness to receive an investigational product - Platforms that enable remote consent are supported by the MHRA, which may reduce hospital visits Involving significant others and clinical nurse specialists (CNSs) in patient consultations: - While at some centres, patients can bring a friend or relative to consultations, at others they cannot due to the limited size of waiting areas and consultation rooms - This also applies to CNSs - Using speakerphone or video consultation software that has been locally approved by the Trust (e.g. Attend Anywhere or StarLeaf) to include friends/relatives and CNSs in consultations has been a popular solution to this problem Mental health burden for ECMC staff: • Feelings of isolation among staff working from home were acknowledged • Staff sickness now higher than during first wave • Strategies in use to mitigate this include: - Regular virtual team meetings - Health and well-being reference groups - Encouragement of participation in mindfulness techniques through programmes such as “Press the Pause Button” • All agreed that the type of visits the patient attends or which ones can be omitted should be decided based on dose escalation vs dose expansion and on each patient’s level • Admin staff are catching up on backlog, this is going well across the board • MHRA brought in a Covid-10 mitigation plan for initial approvals and amendments to ensure patients safety • Commercial study protocols also start to incorporate Covid-19 plans • Steep learning curve for everyone [1]: https://mfr.de-1.osf.io/export?url=https://osf.io/jdmp2/?direct%26mode=render%26action=download%26public_file=False&initialWidth=758&childId=mfrIframe&parentTitle=OSF+%7C+COVID-19+testing+strategies.jpg&parentUrl=https://osf.io/jdmp2/&format=2400x2400.jpeg