public and patient perceptions & insights series april 2014

Public and Patient Perceptions & Insights Series

April 2014

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

Methods

• Survey instrument based in part on past surveys; establish new areas of inquiry

• Input and support from pharmaceutical and biotechnology companies and sites.

• Conducted online January through March 2013

• Collaborated with Acurian – a global provider of patient recruitment and retention services: proprietary database represents people who have explicitly opted-in – via online and offline consumer health surveys -- to receive healthcare information on specific diseases and clinical trial notifications.

Final sample size: N=5,701 (Global)

Primary comparisons: CISCRP 2013: N=5,701 (Global) 2007: N= 4,496 (Global) 2005: N= 998 (US)

Harris Interactive 2005: N=2,935 (Global) 2003: N=2,031 ( (US)

CenterWatch 2005: N=1,170 (US)

Methods: Respondent Characteristics

Final sample composition: (n=5,701)

Gender: 58% Female42% Male

Region: 75% North America 5% South America15% Europe 5% Asia Pacific

Age: 6% 18 to 24 years old12% 25 to 34 years old17% 35 to 44 years old23% 45 to 54 years old26% 55 to 64 years old12% 65 to 74 years old4% 75 or older

Incidence of participation in a clinical trial:

61% Have never participated39% have participated

Response Size by Respondent Experience

General Perceptions (N=5,701)

Have Not Seriously Considered Participating

(N=1,221)

Have Seriously Considered Participating

(N= 4,425)

Has Not Participated (N=2,647)

Has Participated

(N=1,724)

Dropped Out

(N=259)

Completed

(N=1,336)

Generally a 3-percentage point difference between values is significant at the p<.05 level

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

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

How willing are you (‘Very’/‘Somewhat’) to Participate in a Clinical Research Study?

Overall North America

Europe South America

Asia Pacific

18-34 Year Olds

87%93%

58%64%

73% 73%

Base: All Respondents

Public Perceptions

Public Perceptions

CISCRP 2005 CISCRP 2007 CISCRP 2013

86% 88% 87%

Percent ofRespondents

How willing are you (‘Very’/‘Somewhat’) to Participate in a Clinical Research Study?

Evolving Public Perceptions

(Percent who indicated ‘Strongly or Somewhat Agree ‘ that people who participate in clinical trials:

CISCRP 2013 (US)

Harris Interactive 2005 (US)

Percentage point

change

Get access to the best doctors 61% 46% +15

Get access to the best possible treatment 62% 48% +14

Are like experimental test subjects NOT people

34% 46% +12

Make a contribution to science 88% 86% +2

Have a chance to receive free medicines and care

76% 65% +11

Are gambling with their health 23% 49% +26

Learn more about their condition and health 84% 76% +8

Source: CISCRP, 2013 Perceptions & Insights Study; N=5,701 Respondents



AsiaPacific 18-34 year olds

2% 2%7% 9% 6% 5%

17% 15%

40%

22%21% 24%

Not at all informed Not very informed

How would you rate your general knowledge about clinical research?


Public Perceptions

Top Perceived Benefits and Risks

BENEFITS OVERALL FEMALE MALE NA South America

EU Asia-Pacific

Advance science and treatment

33% 35% 30% 35% 25% 26% 23%

Help improve or save lives 29% 30% 28% 30% 20% 28% 21%

Help improve my condition 15% 14% 15% 16% 6% 11% 13%

RISKS OVERALL FEMALE MALE NA South America

EU Asia-Pacific

Possibility of side effects 57% 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%

Top Information Sources

Primary care physician

Specialty care physician

Internet Email Media Mail Family

14%11%

25%

33%

44%

22%

9%

20% 20%

46%

32%

39%

22%

15%

Harris-Interactive 2004 CISCRP 2013

Preferred vs. Actual Information Sources

52%

41%

32%30%

22% 22%20% 20%

13%

20% 20%

46%

32%

39%

21%

8%11%

15%

Preferred Actual


Preferred and actual sources for information about clinical research

Top Sources for Information about clinical research

NAPrefer

NAActual

SAPrefer

SAActual

EUPrefer

EUActual

ApacPrefer

ApacActual

Primary care physician 58% 22% 30% 23% 38% 11% 35% 21%

Specialty care physician 44% 20% 35% 30% 32% 14% 32% 24%

Internet 34% 50% 26% 35% 26% 32% 26% 35%

EMail 36% 40% 15% 13% 11% 6% 11% 11%

Media 23% 41% 21% 24% 19% 32% 19% 33%

Mail 26% 46% 12% 13% 11% 5% 11% 9%

Advocacy groups 24% 13% 12% 10% 12% 5% 13% 7%

Pharmacists 23% 7% 10% 8% 13% 7% 15% 12%

Family 11% 13% 33% 31% 14% 15% 26% 27%

REGION


What social media have you used to learn about clinical research?

OVERALL FEMALE MALE NA SA EU APac

Have not used SM 59% 61% 57% 63% 23% 63% 32%

Facebook 19% 17% 21% 16% 49% 18% 41%

YouTube 8% 6% 12% 5% 35% 11% 25%

Twitter 5% 4% 7% 3% 17% 5% 17%

Message boards 14% 14% 14% 14% 18% 9% 14%

REGIONGENDER


Respondent AGE 18-34 35-44 45-54 55-64 65-74 75+

Have not used SM 37% 53% 62% 67% 73% 75%

Who did you consult with before choosing to participate in a clinical research study?


My primary care physician 61% 63% 60% 66% 36% 51% 43%

My specialty care physician 39% 40% 39% 42% 34% 29% 34%

The Research center conducting the study

30% 34% 25% 34% 15% 20% 21%

My spouse/significant other 31% 31% 31% 33% 18% 25% 26%

My family 27% 28% 25% 24% 44% 31% 44%

My pharmacist 13% 13% 14% 14% 11% 10% 13%

REGIONGENDER


Preferred Screening Method

Screening survey… OVERALL FEMALE MALE NA SA EU Apac

By mail 10% 10% 11% 9% 18% 14% 18%

By email 56% 57% 56% 57% 49% 55% 56%

By telephone 12% 11% 12% 13% 9% 7% 10%

By mobile device 2% 2% 2% 2% 3% 2% 3%

No Preference 20% 20% 19% 20% 21% 22% 12%


Top Reasons for Not Participating

Percent mentioning OVERALL FEMALE MALE NA SA EU Apac

Concerns about risk 26% 29% 23% 26% 19% 29% 26%

Difficult to get to the research center

23% 25% 21% 28% 8% 10% 11%

Did not want to take chance with my health

20% 22% 17% 17% 19% 32% 23%

Too much time required 20% 19% 21% 22% 17% 15% 17%

No reasons in particular 18% 16% 20% 19% 20% 13% 14%

Could not afford time away from my job

18% 18% 17% 20% 14% 12% 13%

Do not want to get placebo

15% 16% 14% 15% 12% 12% 21%

Do not know enough about clinical research

14% 14% 15% 12% 15% 19% 22%

Base: Has Not Participated/Not Willing to Participate

Reasons why you did not qualify for the study?


Don’t Know 35% 36% 33% 35% 33% 37% 33%

REGION

Respondent AGE 18-34 35-44 45-54 55-64 65-74 75+

Don’t Know 41% 34% 38% 33% 26% 43%

GENDER

Base: Wanted to Participate But Did Not Qualify

Losing Ineligible Volunteers

Searched for Another Clinical Trial

Decided not to Participate Nothing

35%

23%

42%Percent of 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);

Losing Ineligible Volunteers


Searched for another trial 35% 35% 35% 35% 43% 32% 31%

Decided not to participate 23% 23% 22% 21% 29% 33% 33%

Nothing 42% 42% 43% 44% 29% 35% 36%

REGIONGENDER

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?

How important were the following factors in influencing your decision to participate?


Quality medical care 85% 90% 79% 90% 55% 61% 58%

Access to medical professionals

83% 88% 78% 88% 57% 63% 57%

Learn about my disease 79% 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 community 61% 65% 57% 62% 63% 57% 53%

REGIONGENDER

Base: Have Participated

Percent rate ‘Somewhat/Very Important’

Participant Experiences

Who reviewed the informed consent form with you?

OVERALL NA SA EU Apac

The study coordinator 50% 52% 34% 39% 48%

Administrator 25% 25% 23% 20% 27%

Principal Investigator 21% 18% 39% 31% 48%

No One 12% 11% 18% 12% 10%


How did you read the informed consent form? OVERALL NA SA EU Apac

Study staff read it to me 10% 9% 11% 15% 25%

I read it together with study staff 18% 19% 13% 13% 22%

I read it by myself 57% 61% 30% 46% 23%

I watched a video 4% 2% 10% 5% 5%

Percent of Respondents

How difficult was it to understand the informed consent form?

(Comparisons with Past Surveys)

Not at all/Not Very Difficult Somewhat/Very Difficult

87%

13%

81%

19%

CenterWatch 2005 CISCRP 2013

How difficult was it to understand the informed consent form?


Not at all difficult 43% 50% 35% 48% 6% 25% 10%

Not very difficult 38% 36% 41% 40% 31% 35% 20%

Somewhat difficult 15% 11% 18% 10% 37% 35% 49%

Very difficult 4% 2% 6% 2% 26% 6% 20%

REGIONGENDER


Respondent AGE 18-34 35-44 45-54 55-64 65-74 75+

Somewhat/Very Difficult

51% 29% 11% 10% 8% 9%

After reading the informed consent form, I was ‘much more’/’somewhat more’ willing to participate

Overall North America Europe South America Asia Pacific

52% 50% 51%

59%

68%


Participant Experience

OVERALL NA SA EU Apac

Not at all/Not very satisfied 15% 12% 34% 33% 29%

Somewhat/very satisfied 85% 88% 66% 67% 71%

OVERALL 18-34 35-44 45-54 55-64 65-74 75+

Not at all/Not very satisfied 15% 28% 18% 13% 11% 10% 11%

Somewhat/very satisfied 85% 72% 82% 87% 89% 90% 89%

AGE



Satisfaction that all questions answered after informed consent form review

What most motivated you to continue participating in your clinical research study?


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% 26% 26% 27% 21% 19% 28%

Positive response to treatment

26% 29% 23% 27% 21% 23% 19%

Free procedures and care I was receiving

26% 26% 15% 27% 15% 14% 31%

My relationship with the study staff

20% 21% 19% 21% 15% 12% 24%

REGIONGENDER

Base: Completed Participation

Who most motivated you to stay in your study?


Myself 72% 75% 68% 76% 47% 48% 52%

Study coordinator 15% 14% 15% 15% 9% 13% 23%

Principal Investigator 9% 7% 11% 7% 17% 15% 27%

My spouse/family 7% 6% 9% 7% 8% 7% 14%

REGIONGENDER

Base: Completed Participation


OVERALL FEMALE MALE NA SA EU Apa

Did not meet them at all 18% 22% 14% 22% 5% 8% 5%

Fell short of meeting them 6% 7% 5% 8% 0% 0% 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?



Asia Pacific

18-34 Year Olds

95% 97%

76%80%

93%

82%



Would you consider participating in another clinical research study in the future?

(percent answer ‘yes’)

A Closer Look at Participants who Dropped Out

Overall Dropped Out Completed

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%

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)

Ken Getz

Founder and Chairman, CISCRP

617-725-2750, [email protected]

Director, Sponsored Research Programs, Associate Professor

Tufts CSDD, Tufts School of Medicine

617-636-3487, [email protected]

Q&A and Thank You!

mailto:[email protected]

mailto:[email protected]

public and patient perceptions & insights series april 2014

Documents

experience slide

patient attitudes

regular assessment of

respondent experience

routine assessment

respondent characteristics

new insights

clinical research