The How, Where, and Why of Clinical Trials

ERIN HAWKS, CCRC

Lost in the woods.

Standard of Care Treatment

Patient

Doctor

Patient’s Personal Support

Nursing Staff

Integrated Care

Standard of Care Treatment with the addition of Clinical Research

Patient

DoctorPatient’s Personal Support

Nursing Staff

Integrated Care

Clinical Research

Topics

• Quick background of clinical research

• What are the barriers that face cancer treatments?

• Where do you find out information about clinical trials?

• And why?

How many cancer patients participate in clinical trials?

• 5%

• 70%

• 60%

• 23.3%

• 1.6%

How many cancer patients participate in clinical trials?• 5% , Less than 5% of Adult Cancer Patients participate in clinical

trials with in the U.S.A.

• 70%, Americans are willing or show interest in participating in clinical trials.

• 60%, American Children with cancer are participating in clinical trials.

• 23.3%, This is the latest data for Children in Idaho participating in clinical trials

• 1.6%, This is the latest data for Adults in Idaho participating in clinical trials

Initial Barriers that Cancer Patient Face

• First Patients need to have access to a cancer clinic.

• Factors that Influence Patient’s Care:

• Transportation

• Travel costs

• Access to insurance

• Availability of child care

Structural Barriers

•Now you are at the cancer clinic,

does this clinic have access to

clinical trials?

In December 2016, Joe Biden helped to established the CANCER MOONSHOT. This initiative aims to accelerate research efforts and break down barriers that are faced.

Which of these facilities have clinical trials available?

• MD Anderson

• MAYO

• Huntsman

• Saint Alphonsus

• Great Falls Clinic

Which of these facilities have clinical trials available?

• MD Anderson

• MAYO

• Huntsman

• Saint Alphonsus

• Great Falls Clinic

THEY ALL HAVE CLINICAL TRIALS AVAILABLE

How do I access clinical trials?

National Cancer Institute (NCI)

• NCI was established through the National Cancer Act of 1937, signed into law by President Franklin D. Roosevelt

• NCORP (NCI Community Oncology Research Program), Created in 1983 by the National Cancer Institute (NCI)

• NCORP currently has over 900 research facilities throughout the nation.

NCORP SITESThroughout

THE NATION

NCORP SITES IN IDAHO AND MONTANA

Montana Clinics or Hospitals:• Benefis Healthcare - Sletten Cancer Institute- Great Falls• Billings Clinic Cancer Center- Billings• Bozeman Deaconess Hospital- Bozeman• Community Hospital of Anaconda- Anaconda• Community Medical Hospital- Missoula• Great Falls Clinic- Great Falls• Kalispell Regional Medical Center- Kalispell• Saint Peter's Community Hospital- Butte• Saint Patrick Hospital - Community Hospital- Missoula • Saint James Community Hospital and Cancer Treatment

Center- Butte• Saint Vincent Frontier Cancer Center- Billings• Saint Vincent Healthcare- Billings

Idaho Clinics or Hospitals:• Kootenai Cancer Center- Post

Falls & Sandpoint• Kootenai Medical Center-

Coeur D'Alene• Saint Alphonsus Cancer Care

Center – Boise, Nampa, & Caldwell

• Saint Luke's Mountain States Tumor Institute- Boise, Meridian, Nampa, Fruitland, and Twin Falls

• Summit Cancer Center- Boise

NCORP GROUPS IN IDAHO AND MONTANAMontana Cancer Consortium: www.MTcancer.org

MT

• Benefis Healthcare - Sletten Cancer Institute- Great Falls

• Billings Clinic Cancer Center- Billings

• Bozeman Deaconess Hospital- Bozeman

• Community Hospital of Anaconda- Anaconda

• Community Medical Hospital- Missoula

• Great Falls Clinic- Great Falls

• Kalispell Regional Medical Center- Kalispell

• Saint Peter's Community Hospital- Butte

ID

• Kootenai Cancer Center- Post Falls & Sandpoint

• Kootenai Medical Center- Coeur D'Alene

• Saint Alphonsus Cancer Care Center – Boise, Nampa, &

Caldwell

Pacific Cancer Research Consortium

MT

• Saint Patrick Hospital - Community Hospital- Missoula

ID

• Saint Luke's Mountain States Tumor Institute- Boise, Meridian, Nampa, Fruitland, and Twin Falls

Colorado Cancer Research Program: www.CO-cancerresearch.com

MT

• Saint James Community Hospital and Cancer Treatment Center- Butte

• Saint Vincent Frontier Cancer Center- Billings

• Saint Vincent Healthcare- Billings

Seattle Cancer Alliance: www.Seattlecca.org

ID

• Summit Cancer Center- Boise

Searching for Clinical Trial

• www.ClinicalTrials.gov

• www.Cancer.gov/about-cancer/treatment/clinical-trials/search

• www.MTcancer.org

• www.CO-cancerresearch.com

• www.Seattlecca.org

• Contacting your local cancer clinic or hospital

Clinical Barriers

• Even if trials are available at this clinic, patients may not be

eligible.

Why?

• Protocol Eligibility has a narrow criteria- patients are excluded

due to safety concerns. It is estimated that 18% of patients that

meet the inclusion criteria will be excluded due to medical

history, previous treatments, co-morbidity/ performance status

(60%), or other factors.

Physician Attitudes• 87% of Oncologist in community cancer clinics feel that clinical trials provide

high quality care and they feel that 83% of enrolled patient benefit from their participation.

• A physician’s role is to guide the patients care in determining trial participation:

• May treat eligible patients off-protocol with the one of the protocol treatment arms.

• May have a strong inclination towards a specific treatment for a given patient.

• May have concerns with the trial participation affecting their relationship with their patient.

• Amount of time dedicated to the responsibilities of clinical research.

• Training for clinical trials

• Finding staff that is willing and eager to be involved in research procedures.

Patient’s Personal Support ?

• Concerns from your family & friends.

• Commitment- Time taken away from family events,

community support, etc.

• Social media, the internet, what’s in the news could be a

barrier

Patient Attitude

• This is the most important barrier to address. We have

navigated through all these previous barriers.

• Clinical Trials are available at a patient’s locate cancer

clinic.

• The protocol is being discussed with the patient by their

physician, nursing staff, or a research team member.

• You are given a consent form to read through.

• And you have to decide to give your consent to participate

in this clinical trial.

What is the consent process?

• Your participation is voluntary

• Prior to signing any document, your participation will be discussed with

you.

• Discuss the clinical trial participation with your family, your friends, your

general practice doctor, your dentist, etc.

• Who is looking out for my safety?

• Has all of my questions been answered?

Other Factors in a Patient Life that will affect their decision

• Transportation

• Travel costs or lodging

• Delay of insurance approval

• Is this information available in my native language

• Availability of child care

Standard of Care Treatment Participate in the Clinical TrialOR

Choose to be made.

References:

• The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies.

(https://www.ncbi.nlm.nih.gov/pubmed/27249699)

• Children’s Oncology Group, (https://www.childrensoncologygroup.org/index.php/what-is-a-clinical-trial)

• https://ncorp.cancer.gov

• http://mcrconline.org/content/about-mcrc-ccop

• Comprehensive Cancer Alliance for Idaho (CCAI) 2016 Data

• Cancer Patient Dresses As Wonder Woman For Last Day Of Chemo, Becomes Our New Hero.

(https://www.huffingtonpost.co.uk/2015/11/26/cancer-patients-dresses-wonder-woman-chemo_n_8654586.html)

• The Male Breast Cancer Coalition: Men Have Breasts Too. (https://medivizor.com/blog/2015/09/10/male-breast-

cancer-coalition-men-breasts/)

THANK YOU.