Abstract
Background/AimsCoronavirus Disease 2019 (COVID-19) has presented an unprecedented challenge for non-COVID related clinical trials of investigational medicinal medicines (CTIMPs). These challenges are considerable for trials run in high -risk groups, such as older adults. Clinical trials must ensure the safety of their participants, whilst also considering the potential, and often long-term, benefits of the trial intervention to public health. Here we sought to provide a brief perspective on the response and conduct of CTIMPs relevant to older adults and neurology in the UK to the COVID-19 pandemic.MethodsWe performed a cross-sectional study, surveying CTIMP teams running trials broadly relevant to older adults and neurology in the UK, as well as sponsors and Clinical Trials Units (CTU), to understand the response and preparedness to the pandemic.ResultsDue to the pandemic, active recruitment has been suspended in more than half of the trials. The primary driver for the temporary halt of recruitment activity was considerations of patient safety. Interestingly, the majority of trials, sponsors and CTUs did not consider pandemic or epidemic outbreaks in their risk assessments before January 2020.ConclusionThese findings support the need to re-evaluate the risk-management approach whereby clinical trials establish contingency plans for predicted but rare events to minimise the disruption to recruitment and clinical trial delivery.
Highlights
Clinical trials have faced an unprecedented challenge in the light of COVID-19
On March 11, 2020, the World Health Organisation (WHO) declared a pandemic which unequivocally complicated the conduct of clinical trials
Urgent strategies were required to ensure the safety of enrolled participants, weighing up the potential risks to participants of acquiring COVID-19 versus the often long-term, benefits of the trial intervention to public health [1]
Summary
Clinical trials have faced an unprecedented challenge in the light of COVID-19. On March 11, 2020, the World Health Organisation (WHO) declared a pandemic which unequivocally complicated the conduct of clinical trials. In the United Kingdom, the Health Research Authorities (HRA) published a response to the pandemic advising clinical trials to evaluate the risk-benefit of their trial in the broader context of the impact of COVID-19 on National Health Service (NHS) staffing, restriction of movement and government advice [2]. The National Institute for Health Research (NIHR) strategic response stated that all non-COVID-19 related trial set-up activity would be temporarily suspended, and trials in the recruitment stage halted on a case-bycase basis to ensure the prioritisation of COVID-19 studies and to enable the redeployment of clinical staff to frontline care [3]. The Medicines and Healthcare products Regulatory Agency (MHRA) have issued pragmatic guidance on how to manage clinical trials during the pandemic, including practical guidance on the safe delivery of Investigational Medical Products (IMPs) to participants in self-isolation, remote monitoring of trials, protocol deviations and ensuring timely and appropriate measures for pharmacovigilance [4]
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