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**Plenary 2: Panel Discussion** During this session, audience questions were directed to the speakers. The following topics were covered: **On the spot clinical risk assessments:** - In a situation where clinicians deem that a minor deviation from protocol is necessary (e.g. blood count is below the standard threshold but to defer treatment would require a second hospital visit and increase risk of exposure to Covid-19), it would be acceptable to make a risk based deviation from protocol as long as decisions are justified and documented. Significant deviations from protocols should be discussed with medical monitors and sponsors. - Protocols going forward should ideally have resilience and flexibility built in to allow clinicians to make risk-based decisions. If not, now is the time to amend them. -Protocols should be amended to incorporate deviations if they are likely to reoccur. This will avoid systematic deviations which are not allowed for as per the GCP regulations. - Patients who are being dosed based on risk-based decisions should be continuously updated on their patient pathway as usual. **Ensuring that the UK remains attractive to industry in delivering early phase cancer research trials post-Brexit:** - Brexit will affect both UK and EU clinical trials, and ongoing projects are underway to streamline trials during Covid-19. The MRHA Clinical Trials Unit group lead existing projects assessing potential improvements to clinical trial timelines to promote clinical trials within the UK. In addition, taskforces have been set up to discuss management of early phase clinical trials during the Covid-19 pandemic. -Trust is essential for attracting pharmaceutical companies to increase the amount of early phase Cancer Research clinical trials in the UK. Demonstrating that there are robust systems in place to deliver trials during the ongoing pandemic, based on established networks and innovation related to EU exit, will help build this trust. - In contrast to other services, standard treatments of cancer patients have continued during the Covid-19 pandemic in many cases. Whilst UK Government has now increased emphasis on continued non Covid-19 healthcare, implications of Brexit on clinical trials during Covid-19 are all uncertain. The desire to keep trials running needs to be balanced with protecting patients. What is most important is how the UK moves forward from here. **Testing for Covid-19 and considering alternative treatment options:** - Protocols for testing clinical trial patients for Covid-19 vary across different trial units. Some units are testing at the start of every cycle, some are testing at the start of cycle one but not after, and others are only testing symptomatic patients. Many units are moving towards more regular testing. - Alternative options to standard of care treatments which consider potential Covid-19 cases should be explored (e.g. less immunosuppressive options).
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