1. “I Am The Key”

2. Our Mission
To assure the development of the means to cure and control cystic fibrosis and to improve the quality of life for those with the disease

3. Team CF People with CF Parents & Families Researchers & Coordinators
Scientists
CF Care Centers
Volunteers

4. Estimate Patient Enrollment

5. Why a Clinical Trial Initiative?
To identify strengths and barriers
To raise awareness
To develop messages and tools to enhance recruiting efforts
To capitalize on strengths and remove barriers
Why has CFF Undertaken this Initiative?
To build awareness about the need for people with CF to participate in clinical trials.
To develop compelling messages to enhance recruiting efforts.
To assess strengths & weaknesses and issues & barriers involved in clinical trial recruitment.
Research to confirm our assumptions about why people participate or not and to base a plan to increase awareness

6. Culture of Research
To have people with CF, parents, clinical and research teams partner together to advance the goal of finding the means to cure and control cystic fibrosis
“A Climate Of Research” – Definition
To have every CF patient and parent/lay caregiver believe that participation in clinical research is their personal, individual responsibility
How does that come about?
- Ingrain the “climate of research” concept into the culture of the entire CF community on an ongoing basis
- Provide the audience with the information and education to fully understand why participation is essential
- Develop the process to ensure that this information is provided to the CF patient or their caretaker immediately upon diagnosis
- Include CF treating physicians and their teams (clinical nurses, research coordinators, physical therapists and social workers) in this process/effort

7. Reasons to Participate
July 2006
N=111
Number of #1 Rankings
Reasons to Participate
The dedication and drive to find a cure is notable on the part of both clinical people and patients/parents
No Experience n=111 survey
What positive factors would you evaluate to reach your decision?
No Survey
Help find a cure = 49%
Early access to new drugs = 23%
Better care = 12%
Other
Money
Free drugs 2

8. Why Never Participated
July 2006
N=111
Number of Responses
Why have you never participated in a clinical trial?
No Experience N=111
“Never asked” is the only significant reason given. “Too young” or “not qualified” are other issues, but far less significant.
Never asked 61 = 55%
Too young 19 = 17%
Not qualified 11 = 10%
Distance 2
Center just accredited 1
Center doesn't do clinical trials 2
Side effects 3
Work conflicts 1
Not sick enough 2

9. Issues at the CF Center Level
Not enough CF research centers
Geographic gaps
Significant economic and infrastructure needs
Staff workload
Patient referral and sharing
Additional
Interviews demonstrated that there are additional factors that will contribute to increased clinical trial participation.
Issues at the CF treating center level
Not enough CF Research Centers
Significant economic and infrastructure needs
Staff workload
Geographic gaps – large areas where no clinical trials are available
Patient referral and sharing – Reluctance of sites who are geographically close to "share" patients due to fear of losing patients to competing site

10. CFFT Therapeutics Development Network 2009
Increased CFFT TDN to 77 sites. 12 sites considered translational centers because they have training/equipment to perform specialized procedures such as Nasal Potential Difference Testing TDN centers. The TDN Coordinating Center is located in Seattle, WA
TDN Coordinating Center
Translational TDN Centers
TDN Centers

11. What is CFF Doing To Raise Awareness about Clinical Trials?
Changing the culture:
“Learn, Ask, Join”
“I Am The Key”
Learn about clinical trials
Ask about trials at your center or get your questions about participating answered
Consider joining a clinical trial and help improve the quality of life and find a means to control/cure CF
Everyone is the Key

12. “I Am The Key” Material Brochure Button Mailer Posters
“The I am the key” material that have gone out across all CF care centers and chapters
Highlight material

13. What is CFF Doing To Raise Awareness about Clinical Trials?
Changing the culture
“I Am”
Toll-free Hotline
Connects callers with CF Centers conducting clinical trials
CF-JOIN
The toll free hotline connects callers with a live person. The caller is asked if they wish to be matched to a clinical trial and then are asked 20 questions . This results in a list of CF clinical trials they may be eligible for in their area or whatever radius of location they provide. The caller is encouraged to contact their CF care center and have further conversation with their providers.

14. What is CFF Doing To Raise Awareness about Clinical Trials?
Changing the culture
“I Am”
CF-JOIN
CF Foundation’s Web site

15. What is CFF Doing To Raise Awareness about Clinical Trials?
Changing the culture
“I Am”
CF-JOIN
CF Foundation’s Web site
Clinical trial search tool

18. Information sheets similar to information on clinicaltrials.gov
Brief study description with word in the glossary highlighted
Inclusion
Exclusion
Contact
Participating centers

20. What is CFF Doing To Raise Awareness about Clinical Trials?
Virtual CF Education Day Web Casts
CF Research: Progress, Hope and Challenges with Bob Beall and Preston Campbell

21. What else is CFF Doing To Raise Awareness about Clinical Trials?
CF Web Casts
CFF Publications
E-blasts

22. What else is CFF Doing To Raise Awareness about Clinical Trials?
CF Web Casts
CFF Publications
E-blasts
CFF YouTube Channel –
clinical trial videos
YOUTUBE videos – several short clinical trial videos from the perspective of adults and child with CF who have been in clinical trials, a mother of the child who participated in clinical trials, physicians, and research coordinator. – SEE next slide for you tube slide

24. What else is CFF Doing To Raise Awareness about Clinical Trials?
CF Web Casts
CFF Publications
E-blasts
YouTube Videos
Staff Awareness

25. Team Effort is the
Key to Success!