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Incorporating Social Media into the Clinical Trial Process

This presentation highlights approaches that help research teams to leverage digital approaches, in particular social media, to support their clinical studies -- from education and recruitment to retention and reporting back results. The talk highlights online tools such as an institutional Clinical Studies Directory and Trial Promoter ( The talk also highlights some of the regular challenges and how to best address them.

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Incorporating Social Media into the Clinical Trial Process

  1. 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. 2. Clinical Trial Process
  3. 3. Social Media Touch Points Engagement, Education, and Recruitment Retention Dissemination of Study Results
  4. 4. It Starts with Your Study Web Page Leverage the Spoke-Hub Model
  5. 5. Your Study Web Page is the Hub Leverage the Spoke-Hub Model H U B Your Study Web Page v Online Search
  6. 6. The Clinical Studies Directory at USC Ref.
  7. 7. Optimized for Mobile Devices
  8. 8. Editable Clinical Study Pages Facilitate Connection with Study Teams Examples of free, public study recruitment pages (currently in testing)
  9. 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. 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, 1. Beware of proprietary information. 1. Avoid making claims of treatment efficacy or side effects. Use disclaimers to reduce risk. [Ref. 13]
  11. 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. 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. 13. The Disease Hashtag Project Ref.
  14. 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. 15. Example: #Leukemia hashtag Ref.
  16. 16. Audience Research Ref.
  17. 17. What Do Influencers Say? What Social Media Platforms Do They Use?
  18. 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. 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. 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. 21. The Science of Social Media Ref. post-types-over-3-5-years.html#
  22. 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. 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. 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. 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. 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. 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. 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. 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. 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. 31. Trial Promoter: Free, Automated Promotion of Clinical Studies on Social Media Ref.
  32. 32. Examples of Automated Social Media Messages
  33. 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. 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. 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. 36. Social Media is only One Aspect of Your Digital Options Web Social Mobile
  37. 37. Did You Know? SC CTSI offers help through the Digital Study Recruitment Center Contact:
  38. 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. 39. Contact Us! SC CTSI | Phone: (323) 442-4032 Email: Twitter: @SoCalCTSI
  40. 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. 8. Jens Manuel Krogstad. Social media preferences vary by race and ethnicity. Web link: ethnicity/ 9. Young African Americans have high levels of Twitter use. Pew Research, 2014. Web link: americans-have-high-levels-of-twitter-use/
  41. 41. References 10. VI. Social Networking. Mark Hugo Lopez, Ana Gonzalez-Barrera, Eileen Patten. Pew Research, 2013. Web link: 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.