Establishing a Culture of Research. Cynthia George, MSN, CRNP Sr. Director Patient Engagement
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1 Establishing a Culture of Research Cynthia George, MSN, CRNP Sr. Director Patient Engagement
2 Cystic Fibrosis Foundation Founded By Parents
3 CF Foundation s Mission To cure CF and provide all people with the disease the opportunity to lead full, productive lives by funding research and drug development, promoting individualized treatment and ensuring access to highquality, specialized care.
4 CF Foundation: Culture of Research Care Center Network Research Development Program Therapeutic Development Network 1960 s 1980s 1990s 2000s 2010s Patient Registry Scientific Advances Clinical Trial Awareness Program Quality Improvement in Clinical Research
5 CF Foundation Care Center Network
6 CF Care Center Model Initiated in 1961 two care centers Currently 119 centers in 47 states and Washington, DC Comprehensive specialized care delivered by multidisciplinary care team Teaching and training in CF Foster an atmosphere for basic and clinical CF research
7 CF Foundation Patient Registry Launched in 1961 GOAL: Disease Surveillance to Track Trends
8 CF Foundation: Culture of Research Care Center Network Research Development Program Therapeutic Development Network 1960 s 1980s 1990s 2000s 2010s Patient Registry Scientific Advances Clinical Trial Awareness Program Quality Improvement in Clinical Research
9 CF Foundation Funding Basic Research 1989 CFTR Gene Discovered D Structure of CFTR Protein Established Door Is Opened To More Drug Discovery Opportunities
10 CF Foundation Vision Drug Development Basic Research Better Therapies for People with CF TDN I Am the Key
11 If you build it, they will come. Field of Dreams
12
13
14 CF Foundation: Culture of Research Care Center Network Research Development Program Therapeutic Development Network 1960 s 1980s 1990s 2000s 2010s Patient Registry Scientific Advances Clinical Trial Awareness Program Quality Improvement in Clinical Research
15 CFFT Research Network: The Therapeutics Development Network (TDN)
16
17 2014 Therapeutics Development Network (7) (7) (74) (74)
18 Evolution of the TDN Primary Focus Phase 1/2 Phase 3 Anticipated Expand Network Size
19 What are key GOALs of the Network? High Quality Studies: Optimize the benefits and minimize risks of studies (Consultation and Protocol Review) Successful Enrollment: Improve access for patients to CF clinical studies Include patients in our protocol review process Foster the development of a Culture of Research within our TDCs
20 Protocol Review Committee GOAL: Ensure quality protocols and patient safety Who: Two clinicians Statistician Research Coordinator Patient/family reviewer What: Consistent high quality reviews Increase likelihood of success and ensure patient safety Consider and reduce patient burden whenever possible
21 Sample Patient Reviewer Feedback The visit schedule is excellent. Could the sponsor provide multiple nebulizers so that I would only have to run my dishwasher 1X per day to sanitize? Would not be interested because my son (who would be eligible) is on continuous inhaled antibiotic therapy and I would not want to risk his being placed in the placebo group.
22 CF Foundation: Culture of Research Care Center Network Research Development Program Therapeutic Development Network 1960 s 1980s 1990s 2000s 2010s Patient Registry Scientific Advances Clinical Trial Awareness Program Quality Improvement in Clinical Research
23 I Am the Key
24 Number of #1 Rankings Reasons to Participate Help find a cure Early access to new drugs Better care July 2006 N=111 Other Money Free drugs 0 No Experience
25 Number of Responses a clinical trial? Never asked Too young Not qualified Distance Newly accredited Doesn't do clinical trials Side effects Work conflicts Not sick enough
26 Goals of the Clinical Trial Program Raise awareness about the importance of clinical trial participation Educate about clinical research Build a partnership between individuals with CF, parents, and the research team
27 I Am The Key Material Buttons Post Card Brochure Posters
28 Educational Resources CFF s website: /ClinicalResearch/ Printed materials The Hotline: CF-JOIN
29 Clinical Trial Search Tool Basic or advanced search options
30 2006: Proportion of patients that reported that they were never asked: Of 111 patients that answered the survey 61 said I was never asked 46% 54% Self identified as never being asked to participate Did not report "not being asked" as a reason
31 2008 Have (you/your family member with CF) ever been asked to participate in a clinical trial? No 3% Yes 97%
32 CF Foundation: Culture of Research Care Center Network Research Development Program Therapeutic Development Network 1960 s 1980s 1990s 2000s 2010s Patient Registry Scientific Advances Clinical Trial Awareness Program Quality Improvement in Clinical Research
33 Quality Improvement in Clinical Research Metrics data indicated variation in site study performance Benchmarking visits to high performing sites
34 Composite Analysis 77 TDN Centers Average Quartile Score for Time to First Patient Enrolled Faster, higher enrolling centers CTSA Weighted Percentage of Patient Population Enrolled in Interventional or Outcome Measure Development Studies
35 Benchmarking Findings Key Drivers of Success Good processes Great people Mature culture of research
36 What is a Culture of Research? We have talked to patients early on about research for about 10 years now. We formalized it because of newborn screening, but you really have to talk to them then because it is important in painting a bright future., we have a consent form for an in-house CF database that gets permission from patients and parents to have their data reviewed for potential eligibility for studies. So it is right up front that research is part of the culture here.
37 Online Quality Improvement Program
38 Fostering a Culture of Research Holding regular joint research and clinical team meetings Discussing research with patients and families at clinic visits on a regular basis, even when not recruiting for a particular study Consistently displaying current research-related material in the offices or clinics Highlighting research in CF center newsletters Establishing patient and family research ambassadors
39 Manuscript Accepted Highly Effective Cystic Fibrosis Clinical Research Teams: Critical Success Factors Journal of General Internal Medicine supplement Research Methods for Evaluating Patient Health Outcomes in Rare Diseases
40 Culminating to date.
41 CF Foundation: Culture of Research Care Center Network Research Development Program Therapeutic Development Network Comparative Effectiveness Research 1960 s 1980s 1990s 2000s 2010s Patient Registry Scientific Advances Clinical Trial Awareness Program Quality Improvement in Clinical Research
42 Comparative effectiveness research Establishing a patient/parent advisory committee Guide outreach and education efforts Collect, prioritize, and refine research topics Participate in protocol development and review
43 Robert Beall Bruce Marshall Preston Campbell Jill Van Dalfsen Chris Dowd Aliza Fink Kris Petren Individuals with CF Acknowledgements
44 QUESTIONS?
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