This year we are celebrating 20 years of Oncology Clinical Trials at the Bon Secours Hospital, Cork, so when I was asked to write this article, I was only too delighted to highlight our work.
Thankfully, the Bon Secours Hospital management team has been very supportive of the service we provide and since I started in the research department in 2012 we have had a significant expansion of our service.
We have expanded from one research nurse to two full time research nurses, a data manager and a part-time trials pharmacist. The team also consists of four Investigators, dedicated radiologists, pathologists, laboratory staff, surgeons and oncology nurses.
Through a lot of hard work, and with these extra resources, it is now evident that our reputation is growing as a clinical research site of interest, both for Cancer Trials Ireland and for commercial sponsors.
At the end of 2016 we set a goal of expanding our clinical trial portfolio from breast and colon cancer trials to ovarian and pancreatic cancers. We also set goals to commence trials involving immunotherapy to give our patients access to better drugs. As a result, we opened the B9991010 Javelin 100 trial (CTRIAL-IE 16-15) of immunotherapy in combination with chemotherapy for newly diagnosed ovarian cancer at the end of 2016. In the space of 12 months we signed 8 patients on to the protocol with 4 patients randomised. This phase III randomised controlled trial (RCT) has given our patients access to a potential breakthrough treatment for ovarian cancer and all patients remain on trial.
We further expanded the profile of clinical trials in the Gynaecology DSSG and opened the Forward-1 trial (CTRIAL-IE 16-68) . This was of particular interest as we were conscious of the need for better treatments for our patients with platinum resistant ovarian cancer for whom the treatment options are so limited.
The Forward-1 trial gives our patients access to mirvetuximab soravtansine, an anti-body drug conjugate which targets folate receptor-α on the surface of the cancer cell. Ireland has the highest accrual per capita with 9 patients on treatment, 7 of whom are at the Bon Secours Hospital, Cork. Dr Murphy is now the Irish Chief Investigator for the Forward-1 trial and is hopeful to bring further trials with this unique anti-body drug conjugate to Ireland as we strengthen ties with Immunogen.
As the oncology clinical trial service has expanded so has the need to be innovative to ensure high standards of care. It has been a challenging period of growth but we see the challenges as opportunities for development of the service. Several innovations such as the expanded role of the research nurse and the creation of the weekly research clinics have improved patient satisfaction. Another key change in recent times has concerned the management of trial blood samples. Previously, these samples were logged on paper biological sample log forms. While this system was satisfactory when we had few patients on trials, we needed a more efficient system as the numbers of patients rose and we found we were spending too much time tracking samples.
In collaboration with the pathology department we initiated electronic trackers for samples (blood, tumour tissue, etc.) from patients participating in all clinical trials. This electronic system has made a huge difference. The research nurse no longer needs to spend time daily in the pathology department.
It has also eased the burden of trial work on the staff in the specimen reception area. We can be confident that samples collected from patients participating in clinical trials are being handled correctly to ensure that the data generated is of high quality as befits the generosity of the patients donating these samples for research.
All of this activity represents serious hard work but we are a team passionate about improving the options for our patients. The patients remain at the centre of every decision we make regarding clinical trials, and we have looked after some incredible people. I would like to take this opportunity to thank our patients and Cancer Trials Ireland which are such a wonderful resource for everyone involved in cancer research in Ireland.
Aoife O'Shea
Oncology Trials Coordinator
Email: AOShea@bonsecours.ie
