1. 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

2. 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

3. 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

4. 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

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

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

7. 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 –
“Drug Approvals – From Invention to Market … A 12 year Trip”

8. 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.
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.

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

10. 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

11. 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

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

13. 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

14. 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

15. 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

16. 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.

17. Questions?

18. Thank You