1. Building Trust, Engaging Communities and Disseminating Results
Ken Getz, Associate Professor and Director, Tufts CSDD
Tufts University School of Medicine
Founder and Chairman, CISCRP
September 2016

2. Key Takeaways
Each individual’s health journey begins before she or he is a patient
The journey is dynamic and unique to the individual
Patients want high-touch while embracing high tech
Patient engagement is more than partnering with the patient alone
The patient sees, and relies on the clinical research enterprise as a coordinated and open ‘system of care’
One bad clinical trial experience or questionable company practice reflects poorly on the entire clinical research enterprise

3. Engagement Friction Points
Abrupt Termination
Limited Transparency
Past Participant
Public
Prospective Volunteer
Study Volunteer
Limited Connection
Poor Relevance
Participation burden
Limited advocacy
Limited HCP Facilitation
Inconsistent & poor access

4. Public Willingness and Self-Reported General Knowledge of Clinical Research
Source: CISCRP 2015; N=8,857 Who Have Never Participated in a Clinical Trial

5. Connection to the Clinical Research Enterprise
Percent who believe they know
where clinical research is conducted
Percent who can name
A living scientist
Source: Research!America, 2010; N=1,000 – 2,000 Adults

6. Who makes a greater contribution to human health?
Appreciation for Study Volunteer Contribution
Who makes a greater contribution to human health?
Source: CISCRP 2015; N=12,009

7. Top Perceived Risks and Benefits
Which ONE of the following do you consider to be the greatest risk/benefit of participating in a clinical research study? (Top 5 Selected)
BENEFITS
RISKS
Source: CISCRP 2015; N=12,009

8. Engagement Friction Points
Past Participant
Public
Prospective Volunteer
Study Volunteer
Limited HCP Facilitation
Inconsistent & poor access

9. Trusted Sources for Clinical Research Information
62% of patients rate their HCP as the top preferred source for information about clinical research
71% of patients say that they would speak with their physician prior to deciding to participate
83% of patients consider their physician’s recommendation a top factor influencing their decision to participate
Percent of Total
Source: Gallup Survey, 2014 (N=6,369 Americans)
Source: CISCRP 2015 P&I study (N=12,009 Global Respondents)

10. Preferred and Actual Sources for Information about Clinical Research Studies
Percent of Total
Source: CISCRP 2015; N=12,009

11. Health Care Provider Experience and Comfort Level Making Referrals
MDs (N=755)
Nurses (N=1,255)
Received special training on CT in school
40%
45%
Attended lecture(s) on CT at society meetings
39%
21%
Consider themselves familiar (SW/Very) with CTs
88%
69%
Comfortable (SW/Very) providing CT info to patients
63%
Comfortable (SW/Very) discussing CT opportunities with patients
91%
72%
Have referred their patients to clinical trials
60%
17%
Source: Tufts CSDD 2015

12. Health Care Provider Referral Behavior
Physicians
(N=465)
Nurses
(N=1,112)
Percent of my patients who have asked to be referred 7% 1%
Median number of patients referred annually 5 2
Median number of patients seen annually
3,100
5,560
Source: Tufts CSDD, 2015

13. Losing Ineligible Prospective Volunteers
What did you do after finding out that you did not qualify for a clinical research study?
Source: CISCRP Volunteers Who Wanted to Participate But Did Not Qualify (N=2,647)

14. Engagement Friction Points
Past Participant
Public
Prospective Volunteer
Study Volunteer
Participation burden
Limited advocacy

15. Complex and Demanding Protocols
(Means)
A Typical Phase III Protocol
Scientific
Total Number of Endpoints 7 13
Total Number of Eligibility Criteria 31 50
Total Number of Procedures
110
187
Total Number of Procedures per visit 10
Proportion of Procedures that are ‘Non Core’
18%
31%
Operating
Median Number of Countries*
4.7
9.5
Median Number of Investigative sites
124
196
Median Number of Patients Randomized
729
597
Total number of data points collected**
494,236
929,203
Source: Tufts CSDD ; *DRI; **Medidata Solutions

16. Study Enrollment Challenges
Doubling Planned Timelines
Enrollment Achievement Rates
Increase in Planned Study Duration to Reach Target Enrollment
Overall
94%
Cardiovascular
99%
CNS
116%
Endocrine/Metabolic
113%
Oncology
71%
Respiratory
95%
1.9
Study timelines are typically extended to nearly double their original duration to meet desired enrollment levels for all therapeutic areas.
Less than half of all patients screened complete clinical trials overall though there is wide variation by therapeutic area with endocrine studies having the lowest trial completion rates (34% of all patients screened).
Oncology studies tend to have shorter timeline extensions to achieve desired enrollment levels compared to endocrine and CNS studies with the longest average study duration extensions.
Source: Tufts CSDD, 2013

17. Most and Least Liked Clinical Trial Elements
MOST LIKED
Percent of Total
LEAST LIKED
Helping advance the treatment of disease
35%
Not knowing whether I was getting the investigational treatment
30%
Helping others who may suffer from my disease
28%
Location of the research center
22%
Compensation that I received
25%
Study visits too time consuming
19%
Care and attention from study staff
21%
Compensation not enough given the demands of the study
16%
Information I learned about my disease
17%
Study procedures too cumbersome
15%
Source: CISCRP, 2015: N= 2,849 Patients Who Completed Participation

18. Positive Volunteer Experiences Overall
Source: CISCRP, 2015: N= 2,849 Patients Who Completed Participation

19. Engagement Friction Points
Abrupt Termination
Limited Transparency
Past Participant
Public
Prospective Volunteer
Study Volunteer

20. Information Shared Post-Participation
What information would you be most interested in receiving after completing your study?
What information did you receive after completing your study?
Percentage that Report Receiving
Summary of my Study Results 9%
Whether I received a placebo or the study intervention 4%
News about my study intervention being approved 7%
CISCRP 2014 Study N=1,072
Source: CISCRP, 2015: N= 2,849 Patients Who Completed Participation

21. The Impact of Familiarity
Non-Participants
Past Participant
Percent very willing to participate (again)
30%
68%
Percent very confident in finding an (another) appropriate clinical trial
18%
46%
Percent very comfortable speaking about clinical trials with others
39%
81%
Source: CISCRP, 2015: N=8,857 non-participants and 3,152 past participants

22. CISCRP’s Model of Engagement
CONNECT Community of Participants and Ambassadors
EDUCATE General Education and Awareness
ENABLE Access, Input, Network of Support
Affiliation initiatives/Alumni Programs
Post Trial Plain Language Communication
Post Trial assessment
Volunteer Ambassadors
Global public and patient assessment
Site/CTSA Support
HC Provider Education and outreach
Pharmacy-directed education
Patient and care network boards
Medical Community Outreach
Search Clinical Trials
ENGAGEMENT
AWARE for All
‘Medical Heroes’ PSA
Media Outreach
Science Museum Exhibit
Educational Outreach
Speakers Bureau
Legislation
Gift of Participation
CISCRP.ORG

23. J

24. Thank You!
Ken Getz
Director, Sponsored Research Programs, Associate Professor
Tufts CSDD, Tufts School of Medicine ,