1. Public and Patient Perceptions & Insights Series April 2014

2. Results Review: Rationale  Increasing enterprise-wide interest in engaging study volunteers as partners in clinical research  Inside knowledge, Trust; Ownership/Support; Collaboration  For 5-7 years, no active and regular assessment of public and patient perceptions and experiences  HarrisInteractive (2005); CenterWatch (2005)  CISCRP’s Objectives:  Resume and establish routine assessment  Identify trends and new insights that inform and educate the enterprise on improving public and patient attitudes and experience

3. Methods

4. Methods: Respondent Characteristics

5. Response Size by Respondent Experience Generally a 3-percentage point difference between values is significant at the p<.05 level

6. Key Insights 1.Generally consistent attitudes with past polls; some areas of notable and significant improvement in public attitudes and perceptions 2.Significant age-related and regional differences observed among public and participants 3.Losing high proportion of participants ineligible for one clinical trial who may qualify for another 4.Wide differences found between those who drop-out versus those who complete their clinical trials

7. General Attitudes  High willingness to participate; consistent with past survey results  High percentage believes that they have a good general understanding of clinical research  General understanding appears to be tenuous and superficial  Trust in the research enterprise, public perceptions of study volunteer motivation, and public attitudes about safety have all improved  Wide differences by region and age group

8. How willing are you (‘Very’/‘Somewhat’) to Participate in a Clinical Research Study? Base: All Respondents Public Perceptions

9. Percent of Respondents How willing are you (‘Very’/‘Somewhat’) to Participate in a Clinical Research Study?

10. Evolving Public Perceptions Source: CISCRP, 2013 Perceptions & Insights Study; N=5,701 Respondents

11. How would you rate your general knowledge about clinical research? Base: All Respondents Public Perceptions

12. Top Perceived Benefits and Risks BENEFITSOVERALL FEMALEMALENASouth America EUAsia- Pacific Advance science and treatment 33%35%30%35%25%26%23% Help improve or save lives29%30%28%30%20%28%21% Help improve my condition15%14%15%16%6%11%13% RISKSOVERALLFEMALEMALENASouth America EUAsia- Pacific Possibility of side effects57%56%58%59%45%53%42% Possible risks to my overall health 20%22%17%19%24%27%21% Possibility of receiving placebo 13%14%12%14%10%7%14% Possible disclosure of my private medical information 5%3%6%3%13%8%13%

13. Top Information Sources

14. Preferred vs. Actual Information Sources Base: All Respondents Preferred and actual sources for information about clinical research

15. Top Sources for Information about clinical research NA Prefer NA Actual SA Prefer SA Actual EU Prefer EU Actual Apac Prefer Apac Actual Primary care physician58%22%30%23%38%11%35%21% Specialty care physician44%20%35%30%32%14%32%24% Internet34%50%26%35%26%32%26%35% EMail36%40%15%13%11%6%11% Media23%41%21%24%19%32%19%33% Mail26%46%12%13%11%5%11%9% Advocacy groups24%13%12%10%12%5%13%7% Pharmacists23%7%10%8%13%7%15%12% Family11%13%33%31%14%15%26%27% REGION Base: All Respondents

16. What social media have you used to learn about clinical research? OVERALLFEMALEMALENASAEUAPac Have not used SM59%61%57%63%23%63%32% Facebook19%17%21%16%49%18%41% YouTube8%6%12%5%35%11%25% Twitter5%4%7%3%17%5%17% Message boards14% 18%9%14% REGION GENDER Base: All Respondents Respondent AGE18-34 35-4445-54 55-6465-7475+ Have not used SM37%53%62%67%73%75%

17. Who did you consult with before choosing to participate in a clinical research study? OVERALLFEMALEMALENASAEUAPac My primary care physician61%63%60%66%36%51%43% My specialty care physician39%40%39%42%34%29%34% The Research center conducting the study 30%34%25%34%15%20%21% My spouse/significant other31% 33%18%25%26% My family27%28%25%24%44%31%44% My pharmacist13% 14% 11%10%13% REGION GENDER Base: All Respondents

18. Preferred Screening Method Base: All Respondents

19. Top Reasons for Not Participating Base: Has Not Participated/Not Willing to Participate

20. Reasons why you did not qualify for the study? OVERALLFEMALEMALENASAEUAPac Don’t Know35%36%33%35%33%37%33% REGION Respondent AGE18-34 35-4445-54 55-6465-7475+ Don’t Know41%34%38%33%26%43% GENDER Base: Wanted to Participate But Did Not Qualify

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

22. Losing Ineligible Volunteers OVERALLFEMALEMALENASAEUAPac Searched for another trial35% 43%32%31% Decided not to participate23% 22%21%29%33% Nothing42% 43%44%29%35%36% REGION GENDER Base: Wanted to Participate But Did Not Qualify Percent select What did you do after finding out that you didn’t qualify for a clinical research study?

23. How important were the following factors in influencing your decision to participate? OVERALLFEMALEMALENASAEUAPac Quality medical care85%90%79%90%55%61%58% Access to medical professionals 83%88%78%88%57%63%57% Learn about my disease79%83%74%84%47%55%59% Receive information about the results after the study has ended 71%73%69%73%68%55%59% Receive regular updates about the research while I’m enrolled 68%70%66%71%59%52%57% Feel part of a community61%65%57%62%63%57%53% REGION GENDER Base: Have Participated Percent rate ‘Somewhat/Very Important’

24. Participant Experiences Base: Have Participated Percent of Respondents

25. How difficult was it to understand the informed consent form? (Comparisons with Past Surveys)

26. How difficult was it to understand the informed consent form? OVERALLFEMALEMALENASAEUAPac Not at all difficult43%50%35%48%6%25%10% Not very difficult38%36%41%40%31%35%20% Somewhat difficult15%11%18%10%37%35%49% Very difficult4%2%6%2%26%6%20% REGION GENDER Base: Have Participated Respondent AGE18-34 35-4445-54 55-6465-7475+ Somewhat/Very Difficult 51%29%11%10%8%9%

27. After reading the informed consent form, I was ‘much more’/’somewhat more’ willing to participate Base: All Respondents Participant Experience

28. AGE Base: Have Participated Participant Experiences Satisfaction that all questions answered after informed consent form review

29. What most motivated you to continue participating in your clinical research study? OVERALLFEMALEMALENASAEUAPac Compensation I expected to receive 35%34%36%37%18%26%25% Keep my promise/commitment 34%37%30%37%25%14%16% Information I learned about my condition 26% 27%21%19%28% Positive response to treatment 26%29%23%27%21%23%19% Free procedures and care I was receiving 26% 15%27%15%14%31% My relationship with the study staff 20%21%19%21%15%12%24% REGION GENDER Base: Completed Participation

30. Who most motivated you to stay in your study? OVERALLFEMALEMALENASAEUAPac Myself72%75%68%76%47%48%52% Study coordinator15%14%15% 9%13%23% Principal Investigator9%7%11%7%17%15%27% My spouse/family7%6%9%7%8%7%14% REGION GENDER Base: Completed Participation

31. Participant Experiences OVERALLFEMALEMALENASAEUApa Did not meet them at all 18%22%14%22%5%8%5% Fell short of meeting them 6%7%5%8%0% Met them 45%41%48%46%25%62%40% Exceeded them 21%20%22%15%55%23%40% Greatly exceeded them 10%9%10%9%15%8%15% Base: Did Not Complete Participation How well did your study meet your expectations?

32. Base: All Respondents Participant Experiences Would you consider participating in another clinical research study in the future? (percent answer ‘yes’)

33. A Closer Look at Participants who Dropped Out OverallDropped OutCompleted Report ‘Somewhat/Very Informed’ about Clinical Research 81%92%95% Percentage consider clinical trials ‘Not at all/Not very’ Safe 6%7%1% Percentage have not used Social Media to find clinical research information 59%46%59% Report that it was ‘Somewhat/Very Difficult’ to Understand the Informed Consent Form 19%35%16% Say they are ‘Somewhat/Very Satisfied’ that their questions were answered during informed consent form review 85%64%89% Consider site visits ‘Very/Somewhat’ stressful 20%38%16% Say they were most motivated by ‘Themselves’ to stay in the study 72%47%78%

34. Next Steps  Disseminating and discussing study findings  Five Summary reports developed for  Research professional community  National Library of Education; HHS  Peer-review and trade publications  ACRP Monitor (April 2014)

35. Ken Getz Founder and Chairman, CISCRP 617-725-2750, kengetz@ciscrp.orgkengetz@ciscrp.org Director, Sponsored Research Programs, Associate Professor Tufts CSDD, Tufts School of Medicine 617-636-3487, Kenneth.getz@tufts.eduKenneth.getz@tufts.edu Q&A and Thank You!