“I Am The Key”

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

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

Estimate Patient Enrollment

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

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

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 54 = 49% Early access to new drugs 25 = 23% Better care 13 = 12% Other 10 Money 5 Free drugs 2

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

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

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. 65 TDN centers. The TDN Coordinating Center is located in Seattle, WA TDN Coordinating Center Translational TDN Centers TDN Centers

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

“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

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 1-877-8CF-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.

What is CFF Doing To Raise Awareness about Clinical Trials? Changing the culture “I Am” 1-877- 8CF-JOIN CF Foundation’s Web site www.cff.org

What is CFF Doing To Raise Awareness about Clinical Trials? Changing the culture “I Am” 1-877- 8CF-JOIN CF Foundation’s Web site www.cff.org Clinical trial search tool http://www.cff.org/research/ClinicalResearch/Find/

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

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

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

What else is CFF Doing To Raise Awareness about Clinical Trials? CF Web Casts CFF Publications E-blasts CFF YouTube Channel – clinical trial videos http://www.cff.org/research/ClinicalResearch/Participate/ 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

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

Team Effort is the Key to Success!