Social Media in Clinical Trial Recruitment & Retention

Transcription

1 May 20, 2013, 4:00pm Social Media in Clinical Trial Recruitment & Retention Evan R. Hempel & Stephanie Millin 1

2 What is Social Media Forms of electronic communication (as Web sites for social networking and microblogging) through which users create online communities to share information, ideas, personal messages, and other content (as videos) (Merriam-Webster) 2

3 Social Media Changed the World 3

4 Not Just Social Media But Access to Social Media 4

5 Who Uses Social Networks? 5

6 Social Networks & Clinical Trials Recruitment Institutional Pages Targeted Advertisement Recruitment Specific Networks Retention Minimizing Lost-to-Follow-up Communication Tool 6

7 Recruiting with Social Networks Phase II study in Neonates of Efficacy, PK and Safety of an Investigational Product Study completed enrollment at nearly half the anticipated rate- 58% of expected time As compared to previous similar study without social network advertising that that took more than 300% of sponsor expected time. Site that used Facebook: Enrolled more than 3 times as many as any other site Total per subject cost was 15-30% lower 7

8 Retention with Social Networks On-going Longitudinal (16 year) Mental Health Clinical Study Several sites included within ICF permission to use Facebook to locate participants and conduct long term follow-up. 8

9 Other Roles for Social Media Networking of Clinical Trial Professionals Tweeting of advertisements Disease-specific support networks Educate about CT and importance 9

10 Smartphones and epro Smartphones have increased access Electronic Patient Reported Outcomes (epro) use mobile phone texting and smartphone app technology to allow direct data collection. 10

11 Why Use Social Media? Speed Cost Effective Leading Mode of Information Sharing Benefits of Social Support 11

12 Social Media Challenges 12

13 Regulatory Concerns with Social Media No clear FDA guidelines Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools (Nov. 2009)1 DRAFT Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (Dec. 2011)2 1. Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. 17 April FDA. 18 May < 2. Guidance for Industry : Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. December FDA. 18 May < 13

14 FDA Notice of Violation and Warning Letters A White Paper, FDA Communications Oversight in a Digital Era: (April 2013)3 In the absence of formal guidance, the most obvious means of assessing regulatory intent is through the issuance of regulatory action letters by FDA s Office of Prescription Drug Promotion. Of 173 regulatory actions letters issued by the FDA only 1 involved a social media platform. 3. Senak, Mark S. FDA Communications Oversight in a Digital Era: " April Fleisman-Hillard International Communications. 18 May < >. 14

15 IRB s and Social Media Most treat advertisements for social media, the same as non-digital advertisements Regulation based on FDA s - Recruiting Study Subjects-Information sheet 4 Protect the safety and privacy of prospective participants and cannot imply : certainty of positive outcome, safety or effectiveness, or free treatment 4. Recruiting Study Subjects - Information Sheet, Guidance for Institutional Review Boards and Clinical Investigators. 18 October FDA. 18 May < > 15

16 IRB s and Social Media (cont.) Variation between IRBs and what is acceptable Some IRB s decline requests to utilize social media platforms Others allow it, but usability will need to be tailored to each IRB s requirements 16

17 Considerations for Using Social Media in Clinical Trials Check current government policies Understand your objective and the social media platforms available Evaluate its use and effectiveness for your trial. 17

18 Social Media Can be a highly effective Tool.

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20 References Guidance for Industry : Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. December FDA. 18 May mation/guidances/ucm pdf Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. 17 April FDA. 18 May obacco/cder/ucm htm Recruiting Study Subjects - Information Sheet, Guidance for Institutional Review Boards and Clinical Investigators. 18 October FDA. 18 May < > Senak, Mark S. FDA Communications Oversight in a Digital Era: " April Fleisman-Hillard International Communications. 18 May < Communications-Oversight-in-a-Digital-Era.pdf >. 18