Investigator Meeting

Meeting The EFIC Regulations

EOS PD- The ProTECTIII Trial

September, 2014

Deneil Harney MPH, MSWHuman Subjects Protection Coordinator

University of Michigan

Outline

• EOS Public Disclosureo Resources –

• ProTECT website• Milestone document 2 of 2

o EOS PD activities conducted for RAMPARTo Capturing EOS PD events in WebDCUo To the FDA

• Talking to the media

EOS PD ResourcesProtectiii.com

Investigator tools > Study Closeout

EOS PD ResourcesEFIC tasks

EOS PD ResourcesEFIC tasks cont.

EOS PD Activities Conducted for RAMPART

EOS PD

METHOD % used % reached

 Examples

Online post 26% 44%

Online releases: local radio, tv and newspaper, institution newpaper, YouTube, and other online media sites, e.g., news-medical.net, Sci Guru, Newsedge, BrainTalk Communities, etc.

Presentation 14% < 1%Grand rounds, community groups, conferences, etc.

Email circular 12% 1%Internal employee & department email groups

Newspaper 10% 44%Local newspapers

Mailing 10% < 1%Local community groups reached during CC

Material distribution 7% < 1%

E.d waiting rm., outpatient neurology clinic, national conferences, religious organizations

Radio announcement 5% 4%PSA

Website article 4% <1%NETT, institution & department websites

Letter to subjects 4% n/a 

Newsletter 3% 4%Local epilepsy, TBI, chapter newsletter

T.V. 2% 2%Local news station

Press release 2% 6%To media outlets

Social media 1% none givenTwitter & fb

Billboard <1 % none givenPublic transit

Total n = 277 5,734,475 

Capturing EOS PD events in WebDCU

Capturing EOS PD events in WebDCU

To the FDA Docket!www.regulations.gov/#!docketDetail;D=FDA-1995-S-0036

Press - How to

Contact your PR Office now– Learn who your PR person is– Let them know the study results are forthcoming (late

fall/early winter)

Media resources available at protectiii.com – If a reporter contacts you– Guidelines for support staff– Tips for working with the news media

• preparing, during and after the interview• tips for radio and tv interviews

Press: How cont.

• Don’t take a direct call from a reporter

• Don’t call back a reporter without your PR person’s help in setting up a meeting

• Don’t ignore a reporters calls or messages , or delay responding – this only makes them angry

Bottom line: If a reporter calls, e-mails, or shows up unannounced, call your PR person. Together, you can decide what to do.

Press: When & Message

o After the manuscript is published• A press release will be made available late fall/winter

o In the interim• Keep it short• Stay on message (reference messages already available)

Study stop – subject notification letterProTECTiii.com Existing EFIC material

Share: “We are working through the academic process and I can’t go any further until the publication is out.”

Press: ProTECT

ProTECT specific•Notify Dr. Wright when:

– you have given a statement to a reporter– you become aware of any bad press published

about ProTECT

Questions?