Embedding trials into clinical practice – Learning from the Covid -19 crisis


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Helen Winter1, Natalie Blencowe, Stephen Lang, Jeremy Bewley, Ben Gibbison, Jane Blazeby
1University of Bristol

Abstract

Background

The impact  from the COVID-19 pandemic on cancer outcomes has to be determined. Concerns persist on the delays in screening, diagnosis and treatment. The need for agile working was exemplified by the Nightingale Hospitals, staff redeployment and integration of virtual consultations. With cancer clinical trials halted, recruitment into COVID-19 research become essential and embedded into the everyday. How the rapid implementation of COVID-19 clinical trials within an NHS organisation during the pandemic is presented.

Method

A COVID-19 senior facilitation committee was set up to provide oversight, maximise staff capacity and resource and prioritise studies. Specific strategies to maximise access and recruitment to clinical trials  were established including a focus on the recruitment of children and those with solid tumours.  These included the presence of a research nurse at clinical ward rounds, the promotion of protocols, informed consent training to all and weekly research meetings to share-best practice. The identification of key learnings from the pandemic for adoption and adaption for increased trial recruitment in the future.

Results

The integration of research into the everyday working of COVID-19 clinical teams  became the norm. Protocol and informed consent training for all staff and the consideration of all patients for trials during clinical ward rounds and multi-disciplinary meetings, have ensured access to trials has become embedded. The integration of research nurses working, upskilling and prompting clinical colleagues has ensured equity of access and provided a research presence and focus during the busy clinical day. The adoption of cross-disciplinary working, sharing best-practice and a can-do culture ensured no patient was denied the opportunity to participate. Three RTCs opened over 7 weeks and between them > 60 patients randomised.

Conclusion

Harnessing momentum and initiatives in recruitment into COVID-19 trials may lead to embedding trials and translational research during the recovery. Increased recruitment to research may accelerate access to innovations and novel drug combinations. How this may impact and counter balance the negative effects on cancer care from the pandemic are worthy of more research.

Impact statement

Learning from the rapid integration of clinical trials during the pandemic may embed the recruitment of more patients during everyday practice.