Impact of the Covid-19 pandemic on haematology research trials at the Christie Hospital
Saleem, Sana Day, Clare Armstrong, Emma-Frances Searle, Emma J
Saleem, Sana
Day, Clare
Armstrong, Emma-Frances
Searle, Emma J
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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
Description
Date
2021
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Saleem S, Day C, Armstrong E, Searle E. Impact of the Covid-19 pandemic on haematology research trials at the Christie Hospital. British Journal of Haematology. 2021;193:87-8.