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Incorporating Social Media in the Clinical Trial ProcessResources and Tactics for Research Teams
Katja Reuter, PhDDirector 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)
Clinical Trial Process
Social Media Touch Points
Engagement, Education, and Recruitment
Retention
Dissemination of Study Results
It Starts with Your Study Web Page
Leverage the Spoke-Hub Model
Your Study Web Page is the Hub
Leverage the Spoke-Hub Model
H U B
Your Study Web Page
ResearcherProfile
v
OnlineSearc
h
Mobile
Yik YakYoutube
Snapchat
PinterestTwitter FacebookLinkedIn
Slideshare
Flickr
The Clinical Studies Directory at USCRef. http://clinicaltrials.keckmedicine.org
Optimized for Mobile Devices
Editable Clinical Study Pages Facilitate Connection with Study TeamsExamples of free, public study recruitment pages (currently in testing)
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
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.
3. Ensure that the trial sponsor is informed of your digital/social media activity.
4. 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).
5. Beware of proprietary information.
6. Avoid making claims of treatment efficacy or side effects. Use disclaimers to reduce risk.
[Ref. 13]
[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
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
The Disease Hashtag ProjectRef. http://www.symplur.com/healthcare-hashtags/diseases/
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.
Example: #Leukemia hashtagRef. http://www.symplur.com/healthcare-hashtags/diseases/
Audience Research
Ref. http://www.socialmention.com/
What Do Influencers Say? What Social Media Platforms Do They Use?
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, …
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
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,
…
The Science of Social Media
Ref. http://danzarrella.com/new-data-the-performance-of-facebook-post-types-over-3-5-years.html#
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.
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)
Protection Against HIPAA Violations and Inappropriate Posting
1. Pay attention to Protected health information (PHI)
2. 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.
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”.
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.
Defining Protected Health InformationPHI 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.
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 Do: 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.
Don’t: Don’t talk publicly, including online, about your participation in a clinical trial. Don’t post 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 clinical coordinator or primary investigator 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 trial posts online, please tell MDF or your trial site. Don’t share or take anonymous advice from “experts” online. The need for confidentiality during clinical trials is a critical issue for our
community. Help spread the word by posting these tips on Facebook and elsewhere. If you see misinformation in online forums, groups or group discussions, point people to verified, accurate information provided in places such as MDF's Study & Trial Resource Center.
Thank you! You are helping change the face and future of this disease. You are an essential part of Care and a Cure for DM
- See more at: http://myotonic.org/careful-social-media-can-undermine-clinical-trials#sthash.0H3t4k2e.dpuf
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.
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.
Trial Promoter: Free, Automated Promotion of Clinical Studies on Social Media
Ref. http://trialpromoter.org/
Examples of Automated Social Media Messages
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].
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].
Social Media MythsMyth: 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].
Social Media is only One Aspect of Your Digital Options
Web Social Mobile
Did You Know?
SC CTSI offers help through the Digital Study Recruitment
CenterContact: [email protected]
Components of the Digital Study Recruitment Center
Free Tools & ApplicationsWeb, Social, MobileClinical Studies DirectoryStudy recruitment pageTrial Promoteri2b2Mobile CommonsResearch Match
Digital Study Promotion
Web, Social, MobileConsultations
Automated, organic (free)Manual, advertising
(recharge)
Social Media User Data AccessSocial media monitoring
Symplur Signals
Evaluationand Tracking
Campaign Analysis
Enhancing study recruitment through digital approaches
Consultations
Contact Us!SC CTSI | www.sc-ctsi.org Phone: (323) 442-4032 Email: [email protected] Twitter: @SoCalCTSI
References1. 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/
References10. 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.
