Catching up with Nicky Cunningham from South Tees on research over the last year
For many of us restarting research is only in relation to recruitment and face to face visits with study patients. Recruitment may have ceased throughout lockdown but follow up of research participants has very much continued, with a greater workload for the research nurses than prior to lockdown. I manage a team of 15 staff supporting 30 studies, follow up wasn’t discontinued in any of these studies, although some staff were redeployed and many of the team were supporting COVID-19 studies. Follow up for our non-COVID studies continued as best we could under these circumstances as we have a duty of care to these participants.
It was a complex operation and a logistical nightmare at times. For one of our Chief Investigator led studies we not only arranged for couriers to send out medications but also blood pressure monitors and blood sugar testing kits to ensure observations were recorded. Some staff even paid for these upfront themselves to ensure no data or safety observations were missed (they were reimbursed of course). Research nurses trained patients over the phone to perform their own observations where needed. Event reporting continued as normal (to meet Medicines and Healthcare products Regulatory Agency and Good Clinical Practice requirements) which took lengthy conversations with patients, relatives and other health care professionals to ensure data was reported as completely and efficiently as possible. For some device studies patients were sent out device recording kits and talked through how to set these up. This work was in addition to supporting the COVID-19 studies and was usually completed at the end of the day following screening, recruitment and follow up for studies such as the RECOVERY trial.
Such emphasis is put on recruitment rather than follow up in research targets, yet the achievement of keeping patients retained and actively participating with good quality data collection is of course essential to any study and takes many workforce hours to achieve. From my experience many of my clinical colleagues and colleagues within research that are not directly involved in research delivery had the view that once research recruitment stopped, our workload and patient contact ceased, but it couldn’t be further from that. Also we now have a ‘backlog’ of face to face contacts to perform if patients are willing to attend. Currently we have had very few patients not wanting to come to the hospital to attend face to face visits, but these visits have been dramatically paired down with phone call consultations happening the day before the visit to ensure patients are in hospital clinics for the minimum amount of time required to perform any study/safety interventions.
I feel the issues going forward for restarting research are to do with the impact of remote patient contact in relation to recruitment. Currently, for our studies, most patients are recruited at the time of their admission to hospital for an event or from face to face clinics where surgery is already planned. One of our commercial studies is a ‘Clinical Trial of an Investigational Medicinal Product’ of patients already discharged from clinical care, this may prove to be difficult and patients may feel differently about coming into hospital. Time will tell with this.
This all being said we are in a fantastic position to continue recruiting participants into research.
