Blog: Delivering the RECOVERY trial at Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Dr Jane Martindale is Research Sponsorship Manager at Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust (WWL). Here, she blogs about how the trust has risen to the challenge to carry out the RECOVERY trial - a top priority study in the research response to COVID-19.
COVID provides unexpected 'bridge' to research-naive colleagues
Our Research and Development (R&D) team were due to present at a national conference in May 2020, to share the success of our World Café event to promote, share and create R&D engagement throughout WWL. One of our principle learning outcomes was that we needed to create a ‘bridge’ between our department and members of our trust and community teams to dispel myths about research. The ‘bridge’ would also take down the barriers that are stopping people from being involved. To my utter amazement, it appears that COVID-19 has become that ‘bridge’.
Research is not a fashionable word. However, never have we needed research so much. Never have we had to engage as a trust at such speed and with so many endeavours; to give our patients the opportunity to receive potential treatments for this dreadful, life-threatening enemy.
'Astonishing' response to RECOVERY trial
Our story began on 17 March 2020, when we received an email asking for our help in urgently setting up a national study. The study is called the RECOVERY Trial (Randomised Evaluation of COVID-19 Therapy). This study, sponsored by the University of Oxford, concentrates on looking at the current range of potential treatments for COVID-19. It is looking to see if any of them would turn out to be more effective in helping people recover than the usual standard of hospital care. Data from the trial is to be regularly reviewed so that any effective treatment can be identified quickly and made available to all patients.
The RECOVERY Trial team aims to constantly review information on new drugs and include promising ones in the trial. In only three days, we had checked that we had all the research requirements in place. Dr Abdul Ashish, Consultant Respiratory Physician and Divisional Medical Director for Medicine at WWL, had agreed to be the Principle Investigator and our pharmacy team had all the medications required and we were ready to go.
The most astonishing statistic is that in only 13 days, our first patient was randomised into the study whilst ‘normal’ NHS expectations for this to happen would be 10 to 12 weeks. Amazingly, we also learnt that we were one of the first three trusts nationally to have recruited patients, surpassing all our expectations. By 2 April 2020, 11 doctors had informed the R&D office that they had completed their training and seven patients had been recruited and randomised into their treatment arm. Just one week later, this number of doctors had risen to 18 which is testimony to Dr Ashish for his passion, dedication and enthusiasm for this research to be so successful in mobilising his troops.
Amendments sorted efficiently
Sharing our story is an honour and has taught me so much about the incredible people that I am privileged to work alongside. On 9 April 2020, completely out of the blue, we received an urgent amendment for the study which asked us to change the inclusion criteria, add a new treatment, take out a treatment, modify capacity restrictions and adjust doses for pregnant women. Amendments carrying such complex changes in the ‘old world’ would take some time; the rule book has been torn up and rewritten. Thanks to the help of a great team, we were able to immediately inform all the doctors, take back all the version-two documentation on each ward and replace them with new packs containing documents with version-three amendments.
Additionally, the Pharmacy team were informed to ensure that the Trust had an adequate supply of the new medication. With relief and joy we discovered that our Pharmacy team were well ahead of the game, pre-ordering a supply of this medication several weeks earlier as they had seen emergent evidence from Korea and France of potential benefits from this. Within the space of two hours, all these changes had been put into place and our patients had the opportunity to be randomised to a further treatment arm.
Over 400 recruits so far
As I write, we are currently the second highest recruiter in the Greater Manchester region with over 400 patients in the study. When we compare ourselves to the giants in our region, this is a wonderful achievement. Our R&D involvement doesn’t end with recruitment, it continues behind the scenes by following each participant’s progress. Thanks to our wonderful electronic systems, our team laboriously record and report precious data back to the ‘great and the good’ within the academic world. By analysis of this data, scientists can identify which medications are helping people to recover more quickly, if indeed they are having any effect. Never have we needed to know as quickly as this if conventional medication can help.
We as a team are walking with you, we cheer when we see our patients discharged and we share your pain and anguish when we see the deceased. Every time you, our wonderful and dedicated front line nurses and doctors, record our patients' observations and progress, you are helping us to see if medications are making a difference. We appreciate how challenging it has been for our doctors to explain about a research study and to gain consent from people who are very ill. We can only imagine how busy you all are and the turmoil of emotions that you are experiencing. Please accept on behalf of your R&D colleagues a most heartfelt thank you for everything that you are doing to help in this essential research.
