1.
Incorporating Social Media
in the Clinical Trial Process
Resources and Tactics for Research Teams
Katja Reuter, PhD
Director of Digital Innovation and Communication
Southern California Clinical and Translational Science Institute (SC CTSI)
University of Southern California (USC)
Presented at: Regulatory Science Bootcamp, Clinical Trial Start-Up: What are the Key Steps and Issues?
(March 23, 2016)

2.
Clinical Trial Process

3.
Social Media Touch Points
Engagement,
Education, and
Recruitment
Retention
Dissemination of
Study Results

4.
It Starts with Your Study Web Page
Leverage the Spoke-Hub Model

5.
Your Study Web Page is the Hub
Leverage the Spoke-Hub Model
H U B
Your Study
Web Page
v
Online
Search

6.
The Clinical Studies Directory at USC
Ref. http://clinicaltrials.keckmedicine.org

7.
Optimized for Mobile Devices

8.
Editable Clinical Study Pages Facilitate
Connection with Study Teams
Examples of free, public study recruitment pages (currently in testing)

9.
Examples of Digital Recruitment Successes
Pregnant women were recruited via Facebook and Twitter in 6
months (12-fold higher rate of ±7.5 recruits/month compared to traditional approach) [Ref. 1]
45
529 Mothers accessed survey -- promoted via Twitter in nearly 3
months; 299 (56.5%) fully completed it [Ref .2]
251 People who had searched for stroke-related information online
completed survey -- promoted via Google Search in nearly 4
months (1% out of 25,292, 200+ website visits/day) [Ref. 3]
Social Media
Search Engine Marketing

10.
Using Social Media for Study Recruitment:
Things to Keep in Mind
1. The creator of social media content is responsible for it.
2. Abide by institution’s media guidelines.
1. Ensure that the trial sponsor is informed of your digital/social media
activity.
1. Refrain from providing significant details of any trial – focus on basic
study information. Suggestion: Link social media content to study page
with more information (e.g., Institutional Clinical Studies Directory, ClinicalTrials.gov).
1. Beware of proprietary information.
1. Avoid making claims of treatment efficacy or side effects. Use
disclaimers to reduce risk.
[Ref. 13]

11.
[Ref. 13]
7. Avoid disclosure of preliminary results or non-public information.
8. Bloggers involved in the study should not write about trial or
drug, device, or treatment (could be viewed as advertising).
9. Avoid using social media for eligibility screening, refer to
institution and study team.
Using Social Media for Study Recruitment:
Things to Keep in Mind

12.
Successful Approaches on Social Media
 Listen to ongoing conversations about the study disease or related
aspects to learn…
First listen, …
Who talks about the disease area?
What do they say?
Who are the influencers in the disease community?
Consider the voices of patients, physicians, disease advocates,
disease foundations, researchers, medical centers

13.
The Disease Hashtag Project
Ref. http://www.symplur.com/healthcare-hashtags/diseases/

14.
Defining: Hashtags
A hashtag is a word or phrase preceded by a hash or
pound sign (#) and used to identify messages on a
specific topic – developed on Twitter and now used on
other platforms such as Instagram and Facebook.

15.
Example: #Leukemia hashtag
Ref. http://www.symplur.com/healthcare-hashtags/diseases/

16.
Audience Research
Ref. http://www.socialmention.com/

17.
What Do Influencers Say?
What Social Media Platforms Do They Use?

18.
Successful Approaches on Social Media
 Share links: Photos, videos, infographics, tips, novel information,
interesting facts, stats, quotes related to your study
 Answer questions and provide value, e.g., share resources -- re-use
existing content if possible (guide to managing post-surgery pain or
infographic on new treatment option)
 Share random thoughts, e.g., Without clinical studies, medical
treatment would always remain the same. Thanks to all of those who
participate.
 Promote, encourage, and support others
 Target specific populations to increase your relevance
 Use social media advertisement features
First give, …

19.
Advertising Clinical Research Digitally
Social Media and
Search Engines
Organic Advertising
Twitter Yes No
Facebook Yes Yes (Approval required)
Youtube Yes Yes (Approval required)
Pinterest Yes Yes
Instagram Yes Yes
Google Search Yes Yes (Approval required)
Limited overview
Based on platform posting guidelines, March 2016

20.
Successful Approaches on Social Media
 Ask for help or to do something, e.g.,
Then ask, …
complete a survey,
check out a web page,
share feedback on proposed study design,
spread the word,
participate in a clinical study,
…

21.
The Science of Social Media
Ref. http://danzarrella.com/new-data-the-performance-of-facebook-
post-types-over-3-5-years.html#

22.
Using Social Media to Boost Retention
 Social media groups for longer-term engagement, interest,
and retention
 Send updates and reminders via social, email, mobile [Ref.
12]
Give participants the option of choosing how they would like to
be engaged and reminded throughout the study.
Leverage the social media channels that your participants use.

23.
Reporting Results: Keep in Mind
Yes No
Final PDF
produced by
the publisher
Final accepted
version of the
manuscript
US Digital Millennium Copyright Act (DMCA)

24.
Protection Against HIPAA Violations and
Inappropriate Posting
1. Pay attention to Protected health information (PHI)
1. Draft response messages to manage comments that include PHI,
include them in your IRB protocol for review
Examples:
On Twitter: Dear [@mention]: To protect your privacy, we suggest
you delete your message. Please contact us directly URL/or phone
number
On Facebook: Dear [FIRST NAME]: Thank you for your interest in
our clinical study at Keck Medicine of USC. To ensure the privacy
and confidentiality of [your or your family member’s] health
information, we had to delete your comment. To help answer your
question, please contact us directly via [email], text or phone
[PHONE NUMBER]. We’d be happy to give you a call.

25.
What IRB Needs to Know
Examples of social media content for IRB review:
 Layout mockup of the web page, including text and any links
provided to the potential participants
 Text of Google Search ad and a static view of the page to
which the ad will direct traffic
 Text of Facebook post or ad and any images and links that are
included
If the social media content is visible to potential study participants, you
should assume it will need IRB approval.
Let IRB know that your social media recruitment strategy and materials will
comply with existing IRB and applicable FDA regulations related to human
subject research. This means adherence to 21 CFR §56 as explained in the
FDA’s longstanding document titled, “Recruiting Study Subjects – Information
Sheet, Guidance for Institutional Review Boards and Clinical Investigators”.

26.
Defining Protected Health Information
Protected health information (PHI) under US law is any
information about health status, provision of health care,
or payment for health care that is created or collected by a
"Covered Entity" (or a Business Associate of a Covered
Entity), and can be linked to a specific individual.

27.
Defining Protected Health Information
PHI key identifiers must be treated with special care:
 Names;
 Geographical identifiers smaller than a state;
 Dates (other than year) directly related to an individual;
 Phone numbers; Fax numbers; Email addresses;
 Social Security numbers;
 Medical record numbers;
 Health insurance beneficiary numbers;
 Account numbers;
 Certificate/license numbers;
 Vehicle identifiers and serial numbers, including license plate numbers;
 Device identifiers and serial numbers;
 Web Uniform Resource Locators (URLs);
 Internet Protocol (IP) address numbers;
 Biometric identifiers, including finger, retinal and voice prints;
 Full face photographic images and any comparable images; and
 Any other unique identifying number, characteristic, or code except the unique code
assigned by the investigator to code the data.

28.
Managing Active Study Participants
 Help them understand that sharing details about their participation
online can …
 distort the results of the study and essentially cause the trial to fail,
 influence how other people perceive or report their own symptoms,
making it hard to tell whether a given drug or treatment is working,
 unblind the study, i.e., if neither the participants nor the clinical trial site
team knows who is on an active drug or a placebo, some participants may
be taking a placebo. Information you share could lead them to report
symptoms that they are not actually experiencing, and
 be misinterpreted by the public, journalists and others.
 TIPS FOR GETTING IT RIGHT

29.
Getting it Right: Template Language for
Educating Participants
 Do discuss your experience confidentially with your
family and other people who are close to you.
 Do talk with your family doctor and other healthcare providers. It’s
important to let them know that you are in a clinical trial.
 Do ask your clinical trial team to provide guidance about where to
obtain reliable educational material online.
 Do keep a journal or take notes on your cell phone so you can make a
list of things to talk about with your clinical trial doctor and study team at
your clinical trial.

30.
Getting it Right: Template Language for
Educating Participants
 Don’t talk publicly, including online, about your
participation in a clinical trial.
 Don’t post online including on social media about your experience in the
trial, including about side effects or about how you think the drug is working.
 Don’t solicit trial advice or information from online friends or people
other than the primary investigator and study team at your clinical trial site.
 Don’t respond to questions or comments online related to the trial
you’re involved in.
 If you do see study-related posts online, please tell the study team.

31.
Trial Promoter: Free, Automated Promotion
of Clinical Studies on Social Media
Ref. http://trialpromoter.org/

32.
Examples of Automated
Social Media Messages

33.
Social Media Myths
Myth: People don’t want to read about clinical research online.
Actually: The use of the Internet as a top source for clinical
research information has increased significantly (46% in 2013)
[Ref. 4,5].
More than 40% of the public reports that they have used social
media to learn about clinical research, with social network
Facebook topping the list [Ref. 4].

34.
Social Media Myths
Myth: Online patient communities and SM users may not be
representative of disease sufferers.
Actually: Studies to date have shown that the member
demographics in online patient communities are representative of
patients in general [Ref. 6].

35.
Social Media Myths
Myth: Online patient communities and SM users may exclude
certain demographics, e.g., minorities, older adults.
Actually: Recent data indicates that digital media reach all age
groups.
Half of people over 50 and more than a third of people over 65
frequent social networking sites [Ref. 7].
Social media is used by 65% of Whites, 65% of Hispanics and
56% of African-Americans [Ref. 8,9,10].
Social media is used across socioeconomic classes. More than
half (56%) of those living in the lowest-income households use
social media [Ref. 11].

36.
Social Media is only One Aspect of Your
Digital Options
Web Social Mobile

37.
Did You Know?
SC CTSI offers help through the
Digital Study Recruitment Center
Contact: dic@sc-ctsi.org

38.
Components of the Digital Study Recruitment Center
Free Tools &
Applications
Web, Social, Mobile
Clinical Studies Directory
Study recruitment page
Trial Promoter
i2b2
Mobile Commons
Research Match
Digital Study
Promotion
Web, Social, Mobile
Consultations
Automated, organic (free)
Manual, advertising (recharge)
Social Media
User Data Access
Social media monitoring
Symplur Signals
Evaluation
and Tracking
Campaign Analysis
Enhancing
study recruitment
through digital
approaches
Consultations

39.
Contact Us!
SC CTSI | www.sc-ctsi.org Phone: (323) 442-4032 Email: dic@sc-ctsi.org Twitter: @SoCalCTSI

40.
References
1. Shere M, Zhao XY, Koren G. The role of social media in recruiting for clinical trials in
pregnancy. PLoS One. 2014 Mar 26;9(3):e92744. doi: 10.1371/journal.pone.0092744.
2. O'Connor A, Jackson L, Goldsmith L, Skirton H. Can I get a retweet please? Health research
recruitment and the Twittersphere. J Adv Nurs. 2014 Mar;70(3):599-609. doi:
10.1111/jan.12222.
3. Kim AS, Poisson SN, Easton JD, Johnston SC. A cross-sectional study of individuals seeking
information on transient ischemic attack and stroke symptoms online: a target for intervention?
PLoS One. 2012;7(10):e47997. doi: 10.1371/journal.pone.0047997.
4. Report on clinical trial information seekers. Perceptions and insights study. The Center for
Information & Study on Clinical Research Participation; 2013.
5. Harris-Interactive, 2004.
6. Scher, David Lee, “Five advantages of online patient communities,” August 2, 2013.
7. Smith, A. Older adults and technology use. Pew Research Center.
http://www.pewinternet.org/2014/04/03/older-adults-and-technology-use/.
8. Jens Manuel Krogstad. Social media preferences vary by race and ethnicity. Web link:
http://www.pewresearch.org/fact-tank/2015/02/03/social-media-preferences-vary-by-race-and-
ethnicity/
9. Young African Americans have high levels of Twitter use. Pew Research, 2014. Web link:
http://www.pewinternet.org/2014/01/06/african-americans-and-technology-use/young-african-
americans-have-high-levels-of-twitter-use/

41.
References
10. VI. Social Networking. Mark Hugo Lopez, Ana Gonzalez-Barrera, Eileen Patten. Pew
Research, 2013. Web link: http://www.pewhispanic.org/2013/03/07/vi-social-
networking/
11. Social Media Usage: 2005-2015. Pew Research, Oct 2015.
12. Cavallo DN, Sisneros JA, Ronay AA, Robbins CL, Jilcott Pitts SB, Keyserling TC, Ni A, Morrow
J, Vu MB, Johnston LF, Samuel-Hodge CD. Assessing the Feasibility of a Web-Based Weight
Loss Intervention for Low-Income Women of Reproductive Age: A Pilot Study. JMIR Res Protoc
2016;5(1):e30. DOI: 10.2196/resprot.4865. PMID: 26920252A
13. Thompson MA1. Social media in clinical trials. Am Soc Clin Oncol Educ Book. 2014:e101-5.
doi: 10.14694/EdBook_AM.2014.34.e101.