Clinical Trials

What Is A Clinical Trial?

A clinical trial is a research study designed to evaluate treatments. The goal is to find safer and more effective ways to treat or prevent cancer. A clinical trial is also known as a clinical study, research study, or medical research.

Clinical Trials may be done to test one of the following:

• New treatments
• New ways of using treatments already available
• New combinations of existing drugs
• New ways of diagnosing or preventing cancer

 

What Are The Phases Of Clinical Trials?

Clinical trials are conducted in an orderly series of steps, called phases. This allows doctors to ask and answer questions in a way that results in reliable information about the treatment and protects the patients. Clinical trials are usually classified into one of four phases. In the Bon Secours Cork, we focus on Phase II and III trials, which are explained below.

Phase II trials:  These studies follow the phase I trials and by this time doctors already know quite a lot about the treatment. A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works and for which types of cancer it might be useful. These studies involve more patients, between 100-300.

Phase III trials:  These studies follow the phase II trials and the aim is to compare a new drug or a new combination of drugs in comparison to the current standard treatment. Phase III trials often enrol large numbers of patients (1000-3000) and may be conducted at doctors' offices, clinics, and cancer centres worldwide.

 

Why Are Clinical Trials Important?

Today's clinical trials lead to tomorrow's standard treatment. The information obtained from a clinical trial advances our progress in the fight against cancer. Without clinical trials, and without the assistance of patients willing to enrol onto these trials, our treatments for cancer would never improve.

What is standard treatment? Standard care is a treatment option that has been proven effective and is currently being used. Today's standard treatments were first shown effective in clinical trials in the past.

 

What Are The Benefits Of A Clinical Trial?

Patients participate in clinical trials for many reasons, usually hoping for a better treatment or cure. However, there are no guarantees but doctors who conduct clinical trials believe the new treatment will provide benefits equal to or better than the current standard of care. The advantage of participating in a clinical trial is that you may be one of the first to benefit from the latest cancer treatment. Patients in clinical trials receive close medical follow-up during and after the trial. Many patients feel a greater sense of purpose by participating in a clinical trial as many of the treatments that we now benefit from, started as a clinical trial less than a decade ago.

What Are The Drawbacks Of A Clinical Trial?

Clinical trials are carefully designed to minimize the risks and maximize the benefits to all the people who take part, regardless of which treatment they get. A trial treatment as well as standard treatment has side effects. Since clinical trials are studying new treatments, not all the side effects may be known ahead of time. You may not always receive the new treatment or the new treatment may not prove to be any better than standard treatment. Even if the new treatment is effective for some people it may not be as effective for you. When you take part in a trial you will be monitored carefully during and after the study. You will have regular tests and you may be asked some extra question about how you are feeling. Sometimes this means going to your hospital or GP more often than you would normally. Although this may inconvenient, these tests only lead to you being observed more closely.

Who Is Eligible For A Clinical Trial?

Each study has its own guidelines called eligibility criteria. Inclusion criteria may consist of things like disease type, medical history, age, gender and other factors necessary to join the trial.

Patient suitability - It is important to remember clinical trials are not suitable for all patients. Whether you are accepted will depend on your age, medical history, the stage of your cancer, your general health and the results of your blood tests. As part of the trial you may be required to attend hospital regularly. This may mean coming to the Cork University Hospital on a weekly basis for blood tests. Ask, how often you will need to come to the hospital and decide whether you can cope with this amount of travelling

 

Meet the Team 

 

 Dr. Brian Healey Bird BA MB BCh BAO FRCPI

Consultant Medical Oncologist, Bon Secours Cork  

Senior Clinical Investigator, Cork Cancer Research Centre

Senior Clinical Lecturer & Lecturer in Clinical Education, University College Cork

Areas of expertise:

• Lymphoma
• GI Cancer - colon, oesophagus, stomach, small bowel
• Melanoma
• Lung Cancer
• Cancer Survivorship
• Clinical Trials

Dr. Bird works to combine humane medicine with modern science to give patients and their families the best possible outcome at a difficult time.

Dr Bird has conducted research and presented findings at numerous international conferences in the areas of lymphoma, breast cancer and colon cancer. He actively supports the Irish Cancer Society and Cunamh, the Bon Secours cancer charity and regularly delivers national and regional educational talks to patients and their families. Since returning to Cork he has lead many clinical trials at Bon Secours Cork.

 

Dr Murphy BA MB BCh BAO FRCPI

Consultant Medical Oncologist Bon Secours Hospital Cork Senior Lecturer in Clinical Education University College Cork 

Chief Clinical Information Officer, Bon Secours Health System.

Areas of expertise:

• Breast cancer
• Gynaelogic malignancies e.g.ovarian
• Urologic malignancies e.g. prostate, kidney, bladder
• Clinical Trials

Dr Murphy studied medicine at NUI Galway, and completed his specialist registrar training in medical oncology in Ireland before completing a 2 year advanced medical oncology fellowship at Memorial Sloan-Kettering Cancer Center in New York.

Dr Murphy commenced his position as a Consultant Medical Oncologist at the Bon Secours Health System in Cork in August 2010. an active member of Cancer Trials Ireland and has acted as national lead investigator for several key clinical trials for cancer patients. With the clinical trial team at Bon Secours Cork, Conleth has opened a number of important trials which seek to build on current treatments to improve the outlook for patients with cancer.

 

Dr Deirdre O’Mahony BA MB BCh BAO FRCPI

Areas of expertise:

• Breast Cancer
• Lymphoma
• Sarcoma.

Dr O’Mahony graduated from University College Cork in 1995 and completing speciality training in Medical Oncology in Ireland, in addition to a MSc in Molecular Medicine from Trinity College, Dublin. From there, she completed a post graduate fellowship in the world-renowed US National Cancer Institute in Bethesda, Maryland.  She continued there as a Consultant, continuing her research into viral associated malignancies.

In 2008, she returned to St James' Hospital, Dublin as a Consultant Medical Oncologist.  She moved to serve the Cork/Kerry region in 2012. A long-standing member of the Lymphoma Forum of Ireland, she was recently nominated as its Chairperson.  She co-founded the Irish Sarcoma Group and advocates for streamlining of sarcoma services in Ireland.  She is an advisor to the National Cancer Control Programme (NCCP) and serves on various of sub-specialty advisory groups.  She has been active in clinical, academic and research programs.  She is the Irish Society of Medical Oncology (ISMO) president and Committee member of the American Society of Clinical Oncology (ASCO) International Quality Task Force.  

 

Dr Paul Kelly MB BCh BAO BMedSci MRCPI FFR (RCSI) ESTRO Fellow

Dr Paul Kelly is a graduate of University College Cork and completed General Professional Training in medicine at the Mater Hospital, Dublin. Having acquired Membership of the Royal College of Physicians he completed specialist training in Radiation Oncology at St Luke’s Hospital in Dublin. He became a Fellow of the Faculty of Radiology at the Royal College of Surgeons in Ireland in 2008 and, thereafter, completed a 2-year Clinical Fellowship in Stereotactic Radiosurgery at Brigham and Women’s Hospital/Dana-Farber Cancer Institute in Boston, Massachusetts.

Based in Cork since 2011 as a Consultant Radiation Oncologist he is active in clinical research and co-chairs the GU disease-specific subgroup (DSSG) of Cancer Trials Ireland. His chief interests include prostate cancer, brain tumours, stereotactic radiotherapy and prostate seed brachytherapy. He took up a position as Medical Director of the new radiation oncology facility at the Bon Secours Radiotherapy Centre joint venture with University of Pittsburgh Medical Centre (UPMC) Hillman Cancer Centre in 2019.

 

Erica Bennett 

Erica is a Senior Clinical Research Radiation Therapist and Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer Centre. She has over 20 years’ experience treating cancer patients and completed her MSc in Healthcare Ethics and Law last year. Her main duties include managing and co-ordinating radiotherapy clinical trials and being responsible for patient care together with the medical team. She is passionate about developing and improving oncology patient outcomes and experience through prehabilitation and clinical trials

 

 

Evelyn O'Sullivan Greene

I am the Team Lead of the Cancer Clinical Trials team in the Bons. My role is extremely varied. I am responsible for setting up clinical trials within the Bons, the overall management of the unit and of course, managing the care and treatment of patients who participate in clinical trials.

I qualified as a Paediatric and General Nurse in 2017, commenced my Masters in Clinical Trials with UCC in 2018 and graduated from that Masters with a first class honours in 2021. I commenced work in the Bons Cancer Clinical Trials team in 2019 as a Research Nurse and commenced the role of Team Lead (CNM2) in April 2021.

I am passionate about clinical trials as it provides patients with an option which they may not be able to receive otherwise and I have seen the difference clinical trials can make to the lives of our patients. They also improve cancer care for patients of the future by improving our knowledge of cancers, testing new and novel ways of diagnosing cancers and providing evidence towards best practice and treatments.

 

Siobhan Finn

I have worked in the Bon Secours Cork as a Cancer Clinical Trials Data Manager since 2015. Prior to working in the Bons, I worked in clinical trials in the CUH. I love working with data as I am pedantic about dotting the i’s and crossing the t’s.

I am responsible for the creation, updating, maintenance and validation of clinical trial databases, and for the provision of computerised reports of these data. The role of Data Manager is to ensure the data is accurate and consistent before it is passed on to the study team for analysis which will determine the outcome of the trial. The responsibilities of the Data Manager are to manage clinical trials through review, computerisation, cleaning and auditing of clinical data and databases in compliance with standard operating procedures and regulatory agency guidelines. 

It is great to be part of the Bons Cancer Clinical Trial team as it enables patients to have choice through trials regarding their treatment.

 

Lisa Stack

I currently work as a Research Nurse (CNM1) in the Bons Cancer Clinical Trials Unit. I am responsible for providing education to patients about clinical trials, caring for and treating patients on a clinical trial, collecting data throughout the course of the trial, and inputting that data into the relevant database. Over the past 11 years I have worked in the oncology/haematology setting in the UK, Australia, and Ireland.  I joined the Bon Secours Hospital Cork in 2017, working in both the day-ward and inpatient oncology ward (St Veronica’s and St Bernadettes ward), and more recently the Cancer Clinical Trials team.  I completed my Oncology Nursing H.Dip in UCC in 2018. 

The role of the research nurse is extremely varied and an important part of the role is being the patient advocate. It is vital that the patient’s best interests and goals are at the heart of the care we provide.  A significant part of my role is to listen to a patient’s questions and concerns, and answer those questions to help the patient make an informed decision about participating in a clinical trial. 

The oncology field is constantly changing and I enjoy the challenge of keeping up to date with current practices.  It is great to have the opportunity to be a part of a team that can offer patients access to treatments that would not be available without clinical trials.