Managing clinical trials during Coronavirus (COVID-19)
.This includes .The MHRA will be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time.
We recognise that clinical trial resource may be absent or redeployed from research activities and regulatory affairs towards front-line care.The first priority should be the safety of trial participants and this will remain our focus.This guidance will be updated as the situation changes over time.The stating that they were prioritising nationally sponsored COVID-19 research.On 21 May 2020, to guide the restarting of NIHR research activities which have been paused due to COVID-19.Sponsors planning to restart trials or to initiate new clinical trials should take account of the principles described in the NIHR Restart Framework Document and the considerations set out in this guidance.
Following a risk assessment, any risks to trial participants should be addressed in the benefit-risk section of the protocol along with risk mitigation measures.The safety of the participant is the primary concern, and this must be ensured in any actions taken as the clinical site has a duty of care for the trial participants.
A risk/benefit assessment on a trial by trial basis taking into account participant population, IMP mode of action, trial design etc.
United States
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Cases: 46 252 513
Deaths: 750 423
Recovered: 0
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India
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Cases: 34 321 025
Deaths: 459 652
Recovered: 0
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Brazil
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Cases: 21 835 785
Deaths: 608 235
Recovered: 0
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United Kingdom
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Cases: 9 215 683
Deaths: 141 607
Recovered: 0
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Russia
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Cases: 8 494 589
Deaths: 237 619
Recovered: 0
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