fully accredited since 2006

Embracing Social Media in Research

Announcements

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

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

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

What is social media and why is it important

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

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

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?

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

Research depends on robust RECRUITMENT and RETENTION

2-7% Enrollment rate of adult cancer patients

Of Phase III trials never reach 25% accrual goal 49%

Distinct processes for activation in Phase III trials 296

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

Research communities CONNECTED through social media – “eParticipants”

The Answer!

1 Billion Users

500 Million Users

70 Million Users

300 Million Users

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

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

Regulatory & legal framework

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

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

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

News Stories | Celeb Tweets | Articles

Reviewable?

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

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

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

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

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.

Tips for creating a research social media plan

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

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

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?

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

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

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

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

Moving forward

Social Media Will Become More Prevalent

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

Social media tools can be used with a PLAN in place that addresses:

Rationale for the use 1

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

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

Connect with Quorum Review

CONTACT

SOCIAL MEDIA

EMAIL ClientRelations@QuorumReview.com

RESOURCES QuorumReview.com/RESOURCES

WEB QuorumReview.com

Thank you!