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How Has Covid-19 Had an Impact on Clinical Trials

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Covid-19 and the subsequent lockdowns initiated by governments across the world has had a profound impact on how we live our lives on a daily basis. In many different areas of our life, things have changed dramatically, but what are we seeing in the pharma world, and in particular, what is it we are seeing in terms of clinical trials and the impact of Covid-19? In the UK almost immediately as lockdown was imposed at the end of March, we saw that there was a decline in new clinical trials being put forward and there was a real need for this with the pressure that the NHS has been put under since.

Any new clinical trials were suspended and continue to be suspended, allowing for the clinical staff to be redeployed to frontline care where there is an emergency situation with the high numbers of Covid-19 patients. The National Institute for Health Research (NIHR) also announced around that time that new clinical trials were being suspended so that all covid-19 studies could be prioritised, with the pressing need for a vaccine to be developed as quickly as possible for a global population and the unprecedented complications that will bring to the entire clinical trial process.

The co-lead for the NIHR, Louise Wood, said that studies would be paused, as would the setting up of new Clinical Research Network (CRN) studies to allow for research to focus on covid-19. Trials that were already in the recruitment stage could also be stopped for the time being, but NHS Trusts and health boards can decide to make a decision on each unique case to decide whether or not recruitment goes ahead. The move has seen a stop to clinical trials at University College London Hospital NHS Foundation Trust, including the ROSCO breast cancer trial that was developing two tests to help guide chemotherapy in patients prior to invasive surgery to assist with breast cancer treatment.

The move to focus research and clinical trials towards a vaccine for covid-19 and to test the nation on the effects of covid-19 is understandable as this is the first time we have seen a pandemic take hold in this way with the entire world forced into preventative or slowing measures that has seen the worldwide economy grind to a halt. There were immediately eight urgent public health response studies into covid-19 set up, and new guidance emerged from the Medicines and Healthcare Products Regulatory Agency on how to manage clinical trials during the pandemic. The changes issues included the use of phone calls over face-to-face study visits at a time where the public was being told to stay at home apart from essential shopping or emergency situations.

The new level of flexibility in clinical trials means that patients taking part in all sorts of trials for many different types of research makes it much easier to keep some trails moving forward in some way, but it also offers a better chance to get a wider scope of the population involved in trials and tests for covid-19.

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