Social media is a powerful and widespread source of information and connectivity. Many in research are wondering whether and how to use social media to improve awareness and retention for their clinical trials. Quorum Review's Regulatory Attorney, Dominic Chiarelli, presents about the power of social media and practical tips for how to best harness social media in research.

1. fully accredited since 2006
Embracing Social Media in Research

2. Announcements
http://bit.ly/Revolutionize-Consent http://bit.ly/SiteMatch

3. FDA, OHRP, and HIPAA laws, regulations, and
guidance, as well as the comparable legal
frameworks in Canada
Life science research and IRB review, including
pediatric research, clinical trial compliance and
monitoring, institutional policy improvements,
and intellectual property rights
Juris Doctor from the University of Washington in 2009
Admitted to the Washington State Bar Association (WSBA) in 2010
Registered Patent Attorney and member of the Washington Patent Law Association
Before joining Quorum Review's regulatory department, Mr. Chiarelli worked as a
regulatory analyst and IRB Member with Seattle Children's Research Institute where he
was also a member of their Children's Intellectual Property Group
Prior to obtaining his Juris Doctor, Mr. Chiarelli, who holds a B.S. in Biology, Magna Cum
Laude, worked as clinical research assistant at several major cancer research centers in
Australia, Spain, and the U.S.
Speaker
Areas of
Expertise
Education &
Certifications
Previous
Experience

4. Agenda
What is SOCIAL MEDIA and why it is
important
How social media can and is being
USED IN RESEARCH
The REGULATORY and legal framework
governing recruitment and how it relates
to social media
What IRBs look for when REVIEWING
social media content
Best practice TIPS for creating a research
social media plan

5. What is social media and why
is it important

6. What is the future of research in the
information age?
The internet brings an entire new dimension to
clinical research by offering a widely available
medium in which the public, participants, and
healthcare professionals can:
A New Revolution
Extend their reach
Exchange information
Build lasting highly engaged communities

7. 72% of internet users say they
looked online for health
information within the past
year
52% of smartphone owners
have used their phone to look
up health or medical
information
1 http://www.pewinternet.org/fact-sheets/health-fact-sheet/
The landscape has changed
Digital Medicine
35% of adults have used the
internet to try to determine
what medical condition they
have
18% of internet users have
gone online to locate others
with similar health concerns1

8. An INTERACTIVE platform for
electronic communications,
used by groups of people to
create, share, and exchange
information.
This ability to identify, connect,
and potentially align individuals
can significantly amplify
messages communicated
through social media.
What is Social Media?

9. Josh Hardy was a cancer-stricken 7 year old who had developed a serious
viral infection with no acceptable treatments…
#SaveJosh social media blitz resulted in a new Phase III clinical trial within 4 days!
#SaveJosh

10. Research depends on robust RECRUITMENT
and RETENTION
2-7%
Enrollment rate of
adult cancer patients
Of Phase III trials never
reach 25% accrual goal49%
Distinct processes for
activation in Phase III trials296
Data from: Zon R, Meropol NJ, Catalano RB, et al. American Society of Clinical Oncology Statement on minimum standards and exemplary attributes of clinical sites. J Clin Oncol. 2008;
26”2562-2567; Dilts SM, Cheng SK, Crites JS, et al. Phase III clinical trial development: a process of chutes and ladders. Clin Cancer Res. 2010; 16:5381-5389
Participants Needed
Results of failed
enrollment goals?
Increased costs
Delayed schedules
Inconclusive results

11. Research communities CONNECTED through
social media – “eParticipants”
The Answer!
1 Billion
Users
500 Million
Users
70 Million
Users
300 Million
Users

12. Slow Adoption
FDA cited ThermaSolutions
for off-label promotion on
the basis that its tweets
were broader than the
cleared indications
Why?
Lack of certainty in terms of:
• Review and approval
• Enforcement
• Effect on study integrity
• Return on investment
• Understanding the technology
FDA cited AMARC
Enterprises for off-label
promotion for using its
product Facebook page to
“like” an external post
describing off-label use

13. Have you used social media to recruit, engage,
or retain participants for clinical trials?
We Surveyed Research Site Contacts…
98%
29%
Their own database is
sufficient for now
Want to, but have limited or no
internal resources
Have privacy concerns or need
clear guidelines
Organization blocks use or lacks
presence on social media
No
51%
Yes
49%
697 responses from a Quorum Review IRB
convenience survey

14. Regulatory & legal framework

15. Regulations significantly predate social media
Only have BROAD principles, like:
• IRB’s authority to review and approve all research activities
• Requirement to ensure that informed consent is appropriately sought
• Requirement to ensure that adequate provisions are taken to ensure the
privacy and confidentiality of participants
At the Boundaries
1950 1980 2000 2010 2015

16. We have limited direction
In 2014, the FDA issued three draft guidance documents concerning the
use of social media with approved products
Reading the Tea Leaves
Main TAKEAWAYS include:
Cannot blame the platform
Responsible for all communication
under your control
Have to keep FDA informed of all your
activities

17. Apply the letter and spirit of the regulations
Quorum has embraced social media as a valuable tool. We try and limit
our review to only those materials we consider as reviewable subject
matter.
What is reviewable subject matter?
Any communication specific to a particular clinical trial
that is clearly directed at current or future participants.
Quorum’s Approach

18. News Stories | Celeb Tweets | Articles
Reviewable?

19. Standards for Review
What we are looking for is the same as print materials and generally
centers on communications that could be either inaccurate or
misinterpreted as presented –
Should this
be allowed?
Undue influence
THERAPEUTIC MISCONCEPTION

20. POLL
Which of the following communications
would be allowed?
• Free medicine!
• More frequent monitoring and doctor contact
• New treatment for diabetes #curestrial
• New research for diabetes

21. A hard copy final mock-up
or storyboard, including all
images
All study-specific home
pages, posts, tags, and ads
Social media is handled like all other participant-
facing materials
How to Submit for Review & Approval

22. Review may extend beyond the specific
communications
The “About” tab in Facebook allows for detailed page information:
• Purpose of research
• Purpose of account
• How page will be monitored
• Any limitations on how the page should be used
Additional Considerations

23. Additional Considerations…
Review may include a formal social media
management plan
A plan can take the mystery out of social media:
• Develop a clear strategy and integrated presence
• Define what will be submitted for review and what will not
• Create a matrix of responses to anticipated user
generated content
A good analogy that may be more familiar
would be Quorum’s approach to eConsent and
the review and approval of an eConsent
overview.

24. Tips for creating a research
social media plan

25. Addresses any potential
PRIVACY or confidentiality
concerns
Lessons Learned
A plan FACILITATES REVIEW and improves the
ability to CONNECT
Provides RATIONALE supporting
the use of social media
Describes an internal process
for vetting all communications
for APPROPRIATENESS
Defines what will be
considered IRB-REVIEWABLE
SUBJECT MATTER
Identifies whether
user-generated content
will be active, and if so,
how it will be MONITORED

26. All social media use should be supported by
RATIONALE
Social media is a potent tool which can have a lasting and wide impact
on users. The choice of social media should be carefully considered
and justified.
Twitter, on the other hand, only provides the option of public
versus private tweets, is not widely used, and is generally viewed
as less authentic.
Facebook provides options that help ensure the risks to
participants can be minimized, is widely used by the public, and
has a fairly good reputation.
Rationale

27. The privacy measures taken should be proactively addressed and the
choice of privacy settings justified. This may require consultation with
information technology experts.
All privacy protections should be EXPLAINED
Privacy
Page or Group?

28. All communications should be vetted for
APPROPRIATENESS
Potentially Upsetting?
A Facebook post to a cancer clinical
trial page for an article entitled
“Cancer – Why There’s No Cure”
Potentially Stigmatizing?
A Facebook post to a flu clinical trial
page regarding an upcoming HPV
vaccine trial
Have a formal process in place for reviewing and approving
communications, including those not specific to a clinical trial
Appropriateness

29. What’s the purpose of the communication?
Communications that are directed toward
the public and specific to a particular clinical
trial require prior IRB review and approval
All non-IRB reviewable communications
can be described in general terms by
category—celebrity tweets, news stories,
relevant publications—and representative
examples of each provided
IRB-Reviewable Subject Matter
All communications should be vetted for
IRB-REVIEWABLE SUBJECT MATTER

30. User generated content must be appropriately
MONITORED
Measures should be in place so that user posts are monitored and that
actions can be taken as necessary to ensure participant protection and study
integrity
For example:
How will AEs be handled?
Monitoring

31. Putting It All Together
Best results come from an
INTEGRATED APPROACH
to social media
Direct users to CLINICAL TRIAL
WEBSITES for more complete
information
Goal is to SPEED THE PACE OF
RECRUITMENT, not overwhelm
sites with ineligible participants

32. Moving forward

33. Social Media Will Become More Prevalent

34. Genes for Good
ResearchKit
Social media can
create engaged
communities
and collect data
The Future!
11,000
people signed up for
the MyHeart Counts
app in less than
24 hours

35. Social media tools can be used with a PLAN in
place that addresses:
Rationale for the use1
4 Vetting for IRB-reviewable subject matter
2 Privacy concerns
3 Vetting communications for appropriateness
5 Monitoring user-generated content
It All Starts with a Plan

36. Social media can IMPROVE the research experience:
Benefits
1 Build highly engaged communities
2 Reach more participants
3 Develop more direct & personal relationships
4 Improve research reputation

37. Connect with Quorum Review
CONTACT
SOCIAL MEDIA
EMAIL ClientRelations@QuorumReview.com
RESOURCES QuorumReview.com/RESOURCES
WEB QuorumReview.com

38. Thank you!