HonorHealth Research Institute (HRI) We exist… …To bring Tomorrow’s Cures to our community Today ©2009 James L. Christy Cancer Caregivers Conference Amy Mirabella PhD, RN Oncology Clinical Research Nurse

HRI Snapshot Established November, 2005 Major Gifts: Piper Trust & Stardust Foundation Clinical & Translational Research Focus Emphasis on Precision/Personalized Medicine TGen Primary Scientific Partner Established Collaborations with Major Universities, Institutes & Companies Scope: 200 active studies, 300+ investigators, Service Line Aligned Cancer, Cardiovascular, Ortho/Neuro/Trauma, Bariatric, Imaging, Cancer Transplant Institute, Nursing Exemplar Program: Oncology New Drug Development—Drs Gordon and Von Hoff International Recognition: SU2C Dream Team, Targeted Therapy Breakthroughs

HRI Oncology Early Drug Development Program by numbers Program Portfolio at a glance 100+ active patients currently enrolled on clinical trials 110 open clinical trials in the program 70+ actively enrolling early phase protocols in solid tumors 61 novel therapies currently under testing multiple first-in-human trials with novel MOA/targets 10+ Investigator-Initiated trials 30+ immunotherapy based trials 5 IND submissions 42 early phase trials in pipeline 5 supportive care & QOL Protocols Unique clinical trial intake & navigation platform 100+ dedicated research support staff members Collaborative affiliations with 80+ pharmaceutical companies 3 times awarded SU2C Dream team in Pancreatic Cancer

Cancer Transplant Institute The HonorHealth Research Institute has been developing a clinical trial program within the Transplant Institute starting in mid-2017 Provides expert care for a wide range of both non-cancerous and cancerous blood disorders, including: - Leukemias - Lymphomas - Myelomas

A Culture of Innovation Through Collaboration Harvard Clinical Research Institute USGI  Medical

Unique Environment/Vision Institute Without Walls Collaboration Best Science & Best Care Strategically Focused Accelerate Innovation That Makes a Real Difference Right Here, Right Now

Clinical Trial Participation From Invention to Market Takes an average of 12 years for a drug to go from bench to bedside Only 5 in 5000 drugs that enter preclinical testing progress to human testing(1) Only 1 of these 5 drugs is actually approved 1 – https://www.medicinenet.com/script/main/art.asap?articlekey=9877 “Drug Approvals – From Invention to Market … A 12 year Trip”

Clinical Trial Participation Only 3% to 6% percent of patients with cancer who are eligible for clinical trials participate; this slows the clinical development process significantly, and means that more than 90% of patients with cancer may be missing out on potentially lifesaving new treatments. http://www.cancerresearch.org/patients/clinical-trials#sthash.xUYcQnin.dpuf Major barriers – misconception; mistrust; logistics; cost. In one study published in 2007 looking at barriers to clinical trial participation – 84% of patients were aware of clinical trials and oncologists and patients generally agreed that clinical trials are important to improving cancer treatment. Oncologists and patients were more likely to consider clinical trials in advanced and refractory disease. Random assignment and fear of receiving a placebo were ranked highly by both patients and oncologists. Patients identified Fear of side effects as the greatest barrier to clinical trial pariticpation whereas concologists rand this psychosocial barrier as least important to patients. Standard treatment was thought to be better, fear of being treated like a guinea pig, and distance they have to travel. More patients will be enrolled in clinical trials if they are seen at facilities that offer clinical trials. These facilities, like ours, do not have to be academic centers, there is a push to offer clinical trials to patients close to their homes. Patients who did participate in clinical trials: pleased with their experience, treated with dignity and respect, received good or excellent care; would recommend participation to others; access to the best quality care, benefit future patients, receive newer or better treatments, get more care and attention.

Early Detection Program For the early detection of pancreas, breast, ovarian, and colorectal cancers for patients at high risk

Early Detection Program Information Program launched in November 2015 starting with pancreas cancer. Why? By 2030 PC will be the 2nd leading cause of cancer deaths (US) 5-year survival is 8%, due to PC typically diagnosed at a later stage Currently no national screening guidelines

Early Detection Program Information The Early Detection Program launched in November 2015 1st at-risk pancreatic patient consented 12/2015 Program expanded into breast and ovarian early detection in 2017 Colorectal EDP due to open 10/2018 Currently over 200 participants

How do we do it? Provide individualized risk assessment based upon: Personal medical history Family cancer history Imaging Genetic testing Database and biobanking

Supportive Care in Clinical Trial Setting Supportive Care /Palliative Care Why is this important? Care delivery that optimizes quality of life for patients and families through anticipation, prevention, reduction and treatment of suffering

Supportive Care in Clinical Trial Setting ANA call for action Nurses Lead and Transform Palliative Care Increasing nursing education is essential Educational opportunities Our patients and their caregivers have a LOT to teach us

Supportive care and the role of the nurse in clinical trials Symptom Management and anticipation of symptoms based upon the clinical trial →Physical →Psychological →Social →Spiritual Communication about patient values and their goals of care

Supportive Care Research conducted by Nurses Advance Care Planning: A mixed methods design to describe the patient experience Testing a Patient Educational Intervention to Enhance Health Literacy and Empowerment to Engage in Health Decisions and Treatment to Improve Outcomes Currently surveying caregivers to determine needs and concerns. Plan is to develop a caregiver program.

Questions?

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