Mid-Western Cancer Centre: Cancer Clinical Trials Unit
- About the Cancer Clinical Trials Unit
- What we do
- Central Ethics
- Irish Medicine Board
- Studies currently open to accrual at the Mid Western Cancer Centre
- Our Principal Investigators
- Contact the Clinical Trials Unit
- Useful Links
The Cancer Clinical Trials Unit in University Hospital Limerick was set up through a funding initiative by the Health Research Board which was awarded to Dr. Maeve Leahy in 2001.The Unit provides patients with cancer the opportunity to participate in the assessment of new technologies, potentially bringing benefit and shaping the future approaches to cancer care globally.
Under this initiative Marie Sheehan was employed in 2002 as a Clinical Trial Research Nurse. Patricia Finnegan came on board in 2004, as an additional Clinical Trials Research Nurse. In March 2004 the Clinical Trials Team were relocated to a designated clinical trials office in the Mid Western Cancer Centre. Elaine Mc Carthy and Claire Hynes joined the team in 2007 as job sharing partners for Patricia and Marie. Laura Lowry took over the role of Clinical Trial Data Manager in 2008. Melissa Browne, Research Nurse, joined the team in July 2012.
Today the Clinical Trials Unit, in the Mid Western Cancer Centre, is managed by Dr. Linda Coate, Consultant Medical Oncologist, and is still part funded by a grant from the Health Research Board via the Irish Co-operative Oncology Research Group (ICORG). The Unit is involved in oncology and haematology studies and current disease sites which have trials open to recruitment include breast, lung, lymphoma, myeloma and gynaecological cancers and the list continues to expand.
The success of all trials depends on all members of the multidisciplinary team both within the centre, and the wider hospital community. Certified training sessions on clinical trials and Good Clinical Practice are organised by our clinical trials unit regularly to update the multidisciplinary team in the Mid Western Cancer Centre. It is a requirement that every member of staff involved in clinical trials (doctors, nurses, pharmacy, and clinical trial data managers) must have ICH GCP training every 2 years.
The Cancer Clinical Trials Unit at University Hospital Limerick enables patients with specific inclusion and exclusion criteria to participate in a clinical trial and get access to specific drugs, treatments and medical devices which may not otherwise be commercially available, and may be novel ways of targeting disease. These patients are identified by reviewing referrals to the department and at discussion at the weekly multidisciplinary meetings.
Clinical trials are research studies designed to test new treatments. A clinical trial is set up at the end of a long and careful clinical research process in order to test a newly developed drug or procedure which shows promise. Every clinical trial has guidelines called eligibility criteria that specify who can and cannot participate. To ensure the most reliable results, participants in a clinical trial must be alike in key ways.
Examples of eligibility criteria for a cancer treatment trial include:
- the type of cancer you have
- the stage of your cancer
- your age
- your gender
- what other treatments you are receiving now or have received in the past
In most cases, clinical trials are open to all people who meet the eligibility criteria, regardless of your race, ethnicity, or socioeconomic background. Diversity is important to clinical trials to ensure that the new treatment is safe and effective for all people, and that everyone can benefit from the latest scientific and medical advances. The eligibility criteria for a clinical trial are outlined in its protocol. A protocol is a document for the clinical trial research team that explains all of the details about a clinical trial. Every clinical trial has a principal investigator (PI) in the Mid Western Cancer Centre who is in charge of all aspects of the study, Dr. Linda Coate is the Principal Investigator for the Cancer Clinical Trial Unit at the University Hospital Limerick Group.
Every treatment clinical trial open to accrual in our department has Central Ethics and Irish Medicine Board Approval. This is a mandatory requirement for every treatment clinical trial in Ireland.
If a patient is identified as suitable for a specific study and this study is suitable to their individual needs this will be discussed with the patient by their Consultant. The patient will receive a copy of that study specific Patient Information Leaflet for review. Enrollment in a clinical trial is always voluntary. If a patient does sign the consent form and does participate in the study they may withdraw at any time, for any reason.
Over the past few years we have conducted trials with most of the major pharmaceutical companies and international co-operative groups, such as the National Surgical Adjuvant Breast & Bowel Project (NSABP) and the Eastern Cooperative Oncology Group (ECOG) .
An Ethics Committee and the Irish Medicines Board must both approve a clinical drugs trial for it to proceed in Ireland. In addition, the drugs trial must have a European Clinical Trial number, called a EudraCT number. Many clinical drugs trials are funded by pharmaceutical companies, and these companies (or indeed any external sponsor) are required to sign an indemnity agreement and a clinical trial agreement, which are both legal contracts, with the hospital.
The most recent legislation came into force in Ireland in May 2004. This was the date a statutory instrument called S.I. 190 of 2004 passed the parent EU Regulation into Irish law. There was a transition period of two years during which the previous Irish Clinical Trials legislation operated in tandem with S.I. 190 of 2004. This transition period ended in May 2006, and S.I. 190 now governs clinical drugs trials in Ireland. (S.I. 190 of 2004 has been amended by S.I. 878 of 2004, S.I. 374 of 2006 and S.I. 1of2009)
S.I 190 sets out how many members must be at a meeting in order to have a quorum. It also sets out specific timelines within which an Ethics Committee must make a decision in relation to a clinical trial of a medicine (clinical drugs trial), and in relation to amendments to a clinical drugs trial.
The Irish Medicines Board's role is to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products. The IMB is the regulator. They are a government agency and part of the public sector.
- CADY \ ICORG 08-01
- Proteomic Study of Breast Cancer \ ICORG 09-07
- MYOCET \ ICORG 10-03
- TH v THL \ ICORG 11-10
- APHINITY BIG 04-11\ICORG 11-23
- NSABP B-47 \ ICORG 11-24
- SWOG S1007 \ ICORG 12-01
- SafeHer \ ICORG 12-18
- TRIO 022 \ ICORG 12-43
- SNAP \ ICORG 12-45
- KATHERINE \ ICORG 13-05
- TDM1 KAMILLA STUDY
- ECOG - E1505 \ ICORG 06-36
- Tarceva Biomarker \ ICORG 08-41
- ETOP 2-11 BELIEF \ ICORG 12-24
- ETOP 3-12 EMPHASIS \ ICORG 12-25
- BMS CA184-104 \ ICORG 12-49
- Icon 8
- Denosumab in Patients with Newly Diagnosed Multiple Myeloma Protocol Number 20090482
- Aspire Study
- Celgene Study
- Dr. Linda Coate - Consultant Medical Oncologist: (061) 482013
- Professor R.K Gupta - Consultant Medical Oncologist: (061) 485242
- Dr. Maeve Leahy-Consultant Hematologist: (061) 482618
- Dr. Denis O' Keeffe-Consultant Hematologist: (061) 482642
- Dr. Hilary O'Leary- Consultant Hematologist: (061) 482036
- Dr. Linda Coate, Consultant Medical Oncologist: (061) 482013
- Professor R.K Gupta, Consultant Medical Oncologist: (061) 482542
- Dr. Denis O' Keeffe, Consultant Haematologist: (061) 482642
- Dr. Maeve Leahy, Consultant Haematologist: (061) 482618
- Dr. Hilary O' Leary, Consultant Haematologist: (061) 482036
- Ms. Patricia Finnegan, CNM11 Clinical Trials: (061) 485148
- Ms. Claire Hynes, CNM11 Clinical Trials: (061) 485148
- Ms. Marie Sheehan, CNM11 Clinical Trials: (061) 482893
- Ms. Elaine Mc Carthy, CNM11 Clinical Trials: (061) 482893
- Ms. Melissa Browne, Research Nurse: (061) 485148
- Ms. Laura Lowry, Clinical Trial Data Manager: (061) 485159
- ICORG (Irish Clinical Oncologists Research Group)
- UL (School of Nursing)
- UCD (School of Nursing)
- Stokes Research Institute / UL