Resilience, adaptability and innovation – those at the forefront of delivering cancer clinical research have displayed it all during the COVID-19 pandemic. So, what lessons can we learn for the future of cancer trial delivery? We hear from some of our research nurses and clinical trial experts on harnessing the positives from a year like no other…
Over the last year, the Coronavirus pandemic has had a huge impact on non-COVID clinical research trials. As the nation went into the first lock down, difficult decisions had to be made regarding patients who were taking part in cancer clinical trials.
Obviously, patient safety was a priority, and where it was safe and appropriate to do so, every effort was made to ensure that those patients currently taking part in trials were able to continue to receive their treatment. Whether it was setting up virtual clinics, establishing telephone follow up services or finding ways to deliver medications to patients’ homes, research nurses and clinical trial teams rose to the enormous challenges facing them and their patients.
Ben Hood: “We worked with our patient and public involvement team and the Health Research Authority to develop an electronic consent process”
At the start of the pandemic, we looked at how we could change patient visits to reduce the time they needed to be in the clinic.
We recognised that in some of our research studies, patients were only coming in to give consent to allow us access to their tumour blocks – samples that had already been taken and stored within the NHS. Gaining access to these samples allows researchers to analyse and test them for genetic changes. Importantly, we use this information to find out whether these patients would be eligible for a large-scale clinical trial, potentially giving them access to additional treatment.
We were sure we could change how this was done to improve social distancing in our department, so we worked with our patient and public involvement (PPI) team and the Health Research Authroity to develop an electronic consent process. During a virtual meeting, we would have an initial discussion with the patient to explain how the system works, using presentations as a visual aid, before talking through the consent process. Then, by sharing screens and using Adobe Sign, we would watch each other sign the consent forms. This method also allows family members to be part of the consent process and ask questions that may have been missed by the patient.
Co-designing the process with our PPI team ensured the patient voice was at the centre of this change, and the feedback on this has been great. Most patients agreed it was an easy way to consent, as it dramatically reduced their travel time to appointments and increased accessibility. It has also allowed patients to invite members of their family from anywhere in the world to be part of these discussions, supporting them in making the decision to be part of the trial.
We hope that, in future, electronic consent can be integrated into the standard process for enrolling a patient in a trial, with family members joining virtually. We’ve already received approval to use it in one of our translational studies and we’re keen to develop it further. We have seen the benefits of utilising this technology and hope to develop a means of merging face-to-face research consultations with virtual ones.
Ben is the Cancer Research UK senior research nurse at the Sir Bobby Robson Cancer Research Trials Centre in Newcastle
Karen Turner: “New ways of working were key. Peer support, shared learning and remembering how important it is to ask if your colleague is ‘ok’ became a priority”
As my team and I adapted to being deployed from the University of Birmingham into the local NHS Trust’s COVID-19 clinical research team, we initially faced many difficulties.
Working on complex early phase cancer trials is challenging as many of the patients have exhausted all other standard of care treatment options. My team is passionate about delivering these trials for current and future patients, so the biggest challenge was understanding that this could not happen while the pandemic was at its height. Support for the team was essential as the reality of halting recruitment into cancer trials and the need to support patients and their families during this difficult time began to hit home.
Nurses and trial administrators, who are so used to interacting with patients, had a steep learning curve as we adapted to online and homeworking environments. However, the changes meant that clinical nurses worked within a larger pool of clinical research nurses from various medical teams, and there were certainly positives that came from this. Having more exposure to wider research activity across our hospitals and departments was constructive.
New ways of working were absolutely key. Peer support, shared learning and remembering how important it is to ask if your colleague is ‘ok’ became a priority. It was inspiring to see how quickly the nurses adapted to such an uncertain environment.
As we work to re-start the portfolio of research, it’s clear a lot has changed. This is a new era of virtual patient meetings, remote consent and remote monitoring visits from sponsors – all of which look likely to stay with us. The team here has certainly learnt that you need to adapt constantly. This is a quality research nurses already possess, and one which will be called upon again – the future delivery of cancer clinical trials will most certainly involve adaption and innovation.
Karen is a Cancer Research UK senior research nurse based at the Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham
Mandy Edwards: “Having a single hub for researchers to approach for studies across all health boards in Wales is now being trialled with cancer studies”
During the pandemic, a unified process for setting up Urgent Public Health (UPH) COVID-19 trials was quickly established by Health and Care Research Wales, which included a centralised booking service for vaccine trials.
This team contacted individuals who had registered their interest in vaccine trials, checked their eligibility for the study and booked them an appointment to attend screening and participate in the trials in their local area. Those working from home also helped to coordinate the couriering and transporting of home testing kits and samples between trial sites and participants’ homes where needed.
This collaborative, unified approach meant duplication was avoided and the UPH trials could be set up rapidly. An approach like this will have real implications for how trials in other areas are delivered.
Having a single hub for researchers to approach for studies across all health boards in Wales is now being trialled with cancer studies. In this model, there is a national principal investigator for Wales, with regional health boards hosting and running research with sub investigators. One health board has overall responsibility for leading negotiations with the trial sponsor or funder, as well as setting up service level agreements with the sub investigators at each of the regional health boards.
Because of the pandemic, agreed methods of remote working and oversight mean it is an exciting time to push forward with new approaches to delivering clinical research. It’s also true that awareness of the value of research has never been greater. This can only be a good thing for our patients.
Mandy is the Cancer Research UK senior research nurse for Wales
Lesley Robson: “If lockdown proved nothing else, it showed us we are resilient and creative… we learned that maybe not all visits need to be at the hospital”
When the UK went into lockdown, cancer did not stop. Patients still needed effective treatments for their disease and clinical trials were the only way to know that drugs were safe and effective. Continuing the research was of major importance, not only for patients, but for drug development. We had to find a way to make sure we could maintain patient safety while still running the trials.
If lockdown proved nothing else, it showed us we are resilient and creative. The investigators we work with and research staff faced the same challenges of not being able to see their patients, but they adapted to new ways of monitoring them remotely using technology and good old-fashioned telephone calls. Because hospital visits for patients were reduced, we learned that maybe not all visits need to be at the hospital and checking in with patients virtually can be as effective as seeing them in person. Time will tell if we can do more of this in the early phase of drug development; safety is paramount and the burden on patients can be great, so anything that helps reduce that gets my vote.
Monitoring of trial data has changed. Traditionally this has involved ploughing through volumes of patient notes, but with the move to electronic patient records, searching for information is easier and allows the team to focus on the essential, clean data. We are getting to the stage where on-site visits can be decreased and remote visits performed, so that when on site these will be more targeted and useful for site staff. Without COVID-19 we may have had to wait for many more years before this became acceptable practice, so I hope it continues and becomes more accessible at every site.
Lesley is clinical operations manager at the Cancer Research UK Centre for Drug Development
Andrea Harkin: “We have learned that some new ways of working are better and simpler, and our intention is to use all of them”
At the outset of the COVID-19 pandemic, our sponsors took the decision to immediately suspend any new clinical trials and recruitment of new patients to those ongoing.
As a mid-sized academic clinical trials unit (CTU) with approximately 30-35 clinical trials either open to recruitment or with patients in follow-up, the task of contacting the chief investigators (CIs) and all participating sites in these trials was mammoth. The first days and weeks were a melee of communications with the sponsor, CIs and CTU teams to plan the safe delivery and management of the trials.
It became clear that we needed to carefully consider the scheduling of investigations and how this could be managed simply by the sites delivering them. Protocols had to be as inclusive and pragmatic as possible, whilst ensuring critical endpoints were met. This pragmatic approach was key when minimising the number of patient monitoring visits to sites by actively building in remote monitoring where feasible.
It was crucial that decisions supported the needs of the trial sites and supported all the functional teams within the CTU and the sponsor. It was also important to assess the impact of any decisions made on the integrity of the trial outcomes and to document discussions to produce a clear audit trail. All of this was done whilst working remotely and demanded real adaptability.
What we have learned is that some new ways of working are better and simpler, and our intention is to use all of them to improve the delivery of trials in future.
Andrea is operations director at the Cancer Research UK Glasgow Clinical Trials Unit
It is so important that we harness the positives from this incredibly challenging time. Many practice changes were made in response to the global pandemic, and we should take time to reflect on what these innovations could mean for clinical research delivery.
This time of crisis has provided us with a real opportunity to take these developments and use them to shape the delivery of cancer clinical trials in the future, and ultimately get new cancer treatments to patients quicker.
Anne Croudass is lead research nurse at Cancer Research UK