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PEER REVIEW: BREAST CANCER
The importance of cancer clinical trials as illustrated by HER2+ breast cancer Then and Now: Cumulative effects of 30 years of Research: Targeting HER2, Breast Cancer and Beyond international ethical and scientific quality standard for the designing, conducting and reporting of trials that involve human participants.
Written by Dr Claire Brady. Oncology Clinical Trials Registrar, Cork University Hospital Cancer Clinical Trials Clinical trials are fundamental to advances in healthcare. COVID 19 and the development of effective vaccines have helped shine an important spotlight on the importance of clinical trials. The recent ‘Just Ask 2022’ survey conducted by Cancer Trials Ireland (CTI) showed 78% of the the public surveyed agreed the pandemic has highlighted the importance of clinical trials. The oncology community was one of many groups that celebrated International Clinical Trials Day “Then and Now” on the 20th May 2022. International Clinical Trials Day (ICTD) is held on/ around the 20th May of each year to commemorate the day when James Lind started his clinical trial on scurvy in 1747. This laid the foundation for modern clinical research and is the bedrock on which clinical medicine advancements are made. Why cancer trials are important Clinical trials are the backbone of all progress seen in treatment of cancer. Medical oncology in particular, along with radiation oncology has helped to unite the disciplines of biology, basic research, genetics, immunology, pathology and pharmacology. The collective input of these diverse disciplines has seen
the development of systemic treatments that has resulted in dramatically improved outcomes for patients. This is a dynamic and ever evolving field as shown by the recent ground breaking DESTINY 04 breast cancer trial results presented at the international American Society of Clinical Oncology (ASCO) annual meeting. The National Cancer Control Program (NCCP) was established by the HSE in 2007 to lead in the development and implementation of cancer policies with the aim of standardising and improving national cancer care and patient outcomes. In June 2022, the NCCP launched the Systemic Anti-Cancer Therapy (SACT) Model of Care. The report highlighted the growing incidence and prevalence of cancer in Ireland, with the number of cancers expected to double from 2015 to 2045. This will result in a projected 58-81% increase in the number of patients receiving SACT for cancer during this period. It has set out twenty five key recommendations to optimise SACT services. One of its key recommendations is that ‘all patients should have access to a clinical trial where clinically appropriate’ and that ‘clinical trial services should be enhanced/developed in SACT services to support the availability of trials to all patients undergoing SACT.’ This recommendation is supported by the evidence that treatment on a clinical trial is regarded internationally as the gold standard of care. The report also notes there is evidence to suggest that outcomes for patients treated within the context of clinical trials are superior to those outside formal trials. The central role of clinical trials in cancer care has also being noted in the NCCP
AUGUST 2022 • HPN | HOSPITALPROFESSIONALNEWS.IE
Cancer Strategy 2017-2026. One of its key performance indicators (KPI) is to increase patient participation in cancer therapeutic trials from 3% to 6% by 2020. How cancer trials are conducted in Ireland Cancer Trials Ireland (CTI), established in 1996 (formally known as ICORG) is the leading cancer research trials organisation in Ireland. More than 15,000 Irish patients have particiapted in over 350 cancer trials. It is a not for profit registered charity and is partly funded by the Health Research Board (HRB) and Irish Cancer Society. It has developed strong links with international cancer research groups and has facilitated Irish patients being able to participate in internationally, practice changing clinical trials. It serves as the key link for strategic and coordinated support for the dedicated on site cancer trials units in hospitals across Ireland and the recently formed six cancer clinical trials groups. In 2021, the HRB invested ¤22 million to support the delivery of high quality cancer care in these six cancer trials groups (Children’s Health Ireland Cancer Trials Group, Beaumont Hospital – RCSI University of Medicine and Health Sciences Cancer Trials Group, Irish Research Radiation Oncology Trials Group, UCC Cancer Trials Group, Ireland East Hospital Cancer Trials Group, Trinity Academic Cancer Trials Group.) Regulation of Clinical Trials The conduct of clinical trials is strictly regulated ensuring the fundamental importance of safety for all trial participants. All clinical trials must be conducted within strict national regulations and are underpinned by Good Clinial Practice (GCP). GCP is an
Before a clinical trial can be conducted, it must receive approval by a national ethics committee and/or the Ethics Committee of the hospital in which it is taking place. The recent establishment of the National Ethics Committee aims to streamline this process. Furthermore, a clinical trial involving an investigational medicinal product (IMP) must be approved by the Health Products Regulatory Authority (HPRA). The HPRA ensures that trials are conducted in line with current Irish & EU legislation and standards for clinical research. Clinical trials are subject to continuous data monitoring with strict criteria for reporting serious adverse events. Pharmacovigilance compliance is monitored by HPRA. Study personnel All study personnel involved in the conduct of a study must have up to date GCP training and must receive specific training in relation to the particular study in which they are involved. Compliance with this standard provides public assurance that the rights, safety and wellbeing of people participating in cancer trials are protected and that the resulting clincal trial data is trustworthy. Patient participation Patient participation in clinical trials is entirely voluntarily. It involves a detailed consent process. This involves dicussing both standard of care options in addition to the clinical trial. Armed with this knowledge, a patient can determine what the best treatment plan is for them. Why Cancer Trials are Important – review of 30 years of progress in treating HER2+ breast cancer 15-20% of breast cancers overexpress the HER2 protein and are referred to as HER2+ breast cancer. Before HER2 directed therapy, this subset of breast cancer was recognised
