Impact of the Covid-19 pandemic on haematology research trials at the Christie Hospital

Abstract

Covid-19 has spread across the globe causing a devastating number of deaths and impacting on every aspect of life as never before. The NHS Constitution recognises the important role of the NHS to “conduct and use of research to improve the current and future health and care of the population” [1]. The pandemic demonstrated the ability of the NHS to make meaningful contributions to key clinical research relating to the management of COVID-19 but placed unprecedented challenges on other areas of clinical research. The Christie Hospital is one of the largest dedicated cancer treatment centres in Europe. As well as providing expert cancer care, it is a tertiary research centre with an internationally recognised expertise in cancer research. We looked at the impact of COVID-19 haematooncology clinical research activity at The Christie. Clinical trial activity records were reviewed for the 6-month time periods before (Sept. – Feb. 2019-20), during (Mar. – Aug. 2020) and after (Sept. – Feb. 2020-21) the first UK lockdown. Effects on the opening of and recruitment to clinical trials were analysed. In addition, adaptions made to the delivery of clinical research, were considered. The lockdown brought about a dramatic decline in patient recruitment, from 7 to 2 patients/month. This reflects a decision to almost totally halt recruitment to allow research staff to be redeployed and protocols to be implemented to minimise the risk to research patients from COVID-19 infection whilst on the hospital site. Following this, a cautious recovery period began in which clinical trial recruitment resumed, whilst maintaining COVID-19 safety measures, allowing recruitment recovery to near pre-lockdown levels; 6 patients/month. A delayed effect on new trial opening was observed. In the prelockdown 6-month period, 9 new trials were opened, with 8 opened during lockdown. This fell to 6 trials in the following 6-months. The delayed effect was likely due to the length of the setup process, with much work already having occurred before the lockdown allowing ongoing new trial opening. However, new trial set up has been slow to recover, impacted by ongoing pressures on service departments (e.g., radiology) preventing timely reviews as part of the set-up process. Documented deviations from trial protocol were agreed with sponsors and seen as necessary to conduct clinical haemato-oncology research safely within the setting of a pandemic. Examples documented include switching from face-to-face to remote consultations and omitting or relocating some trial related investigations. A potential impact on data quality was accepted and deviations were recorded to allow review of this impact at a later date. Other key changes included the expediting of a move to allow remote, anonymised, supervised, electronic record access for trial monitoring visits, and specialised courier delivery of trial medication, where appropriate. As a dedicated tertiary cancer hospital, there was organisational motivation to try to safely resume clinical research activity following the first lockdown. The consequences of halting clinical haemato-oncology research on future developments within the field is difficult to quantify but potentially serious. It is essential that clinical cancer research learns to adapt to the ‘new normal’ in the COVID era. [1] Department of Health and Social Care, NHS Constitution for England (2012), accessed 1/2/21