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Webinar: Embracing Social Media in Research


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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.

Published in: Health & Medicine
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Webinar: Embracing Social Media in Research

  1. 1. fully accredited since 2006 Embracing Social Media in Research
  2. 2. Announcements
  3. 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. 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. 5. What is social media and why is it important
  6. 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. 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 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. 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. 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. 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. 11. Research communities CONNECTED through social media – “eParticipants” The Answer! 1 Billion Users 500 Million Users 70 Million Users 300 Million Users
  12. 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. 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. 14. Regulatory & legal framework
  15. 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. 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. 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. 18. News Stories | Celeb Tweets | Articles Reviewable?
  19. 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. 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. 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. 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. 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. 24. Tips for creating a research social media plan
  25. 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. 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. 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. 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. 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. 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. 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. 32. Moving forward
  33. 33. Social Media Will Become More Prevalent
  34. 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. 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. 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. 37. Connect with Quorum Review CONTACT SOCIAL MEDIA EMAIL RESOURCES WEB
  38. 38. Thank you!