July 20, 2016
It’s Guaranteed Not To Work If You Don’t Use It: Site & IRB Perspectives On Digital/Social Media Recruiting Ashley Dixon, IRB Member, Schulman IRB Mark Metzner, Associate Director, Recruiting & Community Affairs, Medpace
About Schulman IRB
Established in 1983 Superior audit history with FDA—five consecutive audits with no findings 21 CFR Part 11 compliant electronic systems Compliant with FDA, OHRP and Health Canada requirements Full Board meetings five days a week Dedicated daily expedited review of qualifying minimal risk protocols
About Schulman IRB
Review outcome provided within one business day of new study review One business day turnaround for complete new site submissions Dedicated streamlined processes tailored to Phase I timelines Expert oncology IRB members experienced in all phases of oncology research ̶ National IRB for Cancer MoonShot 2020 initiative
Customized services for institutions Experienced primary points of contact for sponsors, CROs, institutions and sites
About Schulman IRB
Clinical Quality Assurance (CQA) and Human Research Protection (HRP) consulting services provided by Provision Research Compliance Services
www.provisionrcs.com
schulmanirb.com
About Today’s Presenters Ashley Dixon, ThB IRB Member, Schulman IRB
Bachelor’s Degree in Theology from Apostolic Bible Institute With Schulman since 2007 IRB Member since 2009 Lead IRB reviewer for recruitment and study-related materials Provides guidance to sponsors, CROs, sites and others on developing recruitment content Project lead for Canadian Ethics Board development and implementation
About Today’s Presenters Mark Metzner, BA Associate Director, Recruiting & Community Affairs, Medpace
~10 Years in Clinical Research ̶
Phase I through Phase IV ⋄ Virtually all major indications except oncology & end-stage, including first-inman, vaccine, device, and pediatric ⋄ Responsible for managing call center and database, building and overseeing marketing programs, and troubleshooting and overcoming recruitment challenges
20 Years in Broadcast Radio ̶
Responsibilities included management, sales, marketing, research, and programming
Objectives
Define digital recruitment in clinical research Identify IRB dos and don’ts with digital recruitment content Describe elements of successful digital recruitment Review examples of digital recruitment methods
“Recruitment Materials” Used to Be Limited to:
Newspaper Radio and TV ads Subject/patient letters Screening scripts Newsletters Generic pre-screening informed consent documents Health workshops, screenings and health fairs for recruitment purposes
Regulations and Recruitment
FDA requires that an IRB review and have authority to approve, require modifications in, or disapprove all research activities covered by federal regulations governing human subjects research. 21 CFR 56.109(a) and 45 CFR 46.109(a)
In fulfilling these responsibilities, an IRB reviews the methods and material that investigators propose to use to recruit subjects. FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process. 21 CFR 50.20, 21 CFR 50.25, 21 CFR 56.111(a)(3) and 21 CFR 812.20(b)(11)
Regulations and Recruitment
Code of Federal Regulations ̶ FDA considers claims of safety or efficacy of an investigational product, drug or device to be unlawful promotion of investigational products. 21 CFR 312.7(a), 21 CFR 812.7(d)
FDA Information Sheets Recruiting Study Subjects - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators A Guide to Informed Consent - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators
Regulations and Recruitment
Per the FDA’s Federal Guidance on Recruiting Study Subjects, the IRB should ensure that advertising: ̶ Does not coerce or unduly influence potential subjects to participate. ̶ Does not state or imply a favorable outcome or other benefits beyond that outlined in the consent document and protocol. ̶ Makes no claims, explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation or that the test article is equivalent or superior to any other drug, biologic or device.
Content Guidelines
Avoid language that could create therapeutic misconception. ̶ Occurs “when a research subject fails to appreciate the distinction between the imperative of clinical research and of ordinary treatment and therefore inaccurately attributes therapeutic intent to research procedures.”
Avoid exculpatory language. ̶ OHRP and FDA consider exculpatory language to be language which has the general effect of freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt. Clinical Trials and Medical Care: Defining the Therapeutic Misconception G Henderson, L Churchill, A Davis, M Easter, C Grady, et al, PLoS Med. 2007
Unacceptable Content for Recruitment Materials
Emphasis on subject compensation Misleading mottos or logos – “Tomorrow’s Drugs Today!” Excessive repetition of words such as “free” or “at no cost” Referral fees (finders’ fees) offered to referring physicians or subjects based on enrollment and/or retention
Content Guidelines
Generally, recruitment material should be limited to the following information: ̶ A statement that the study involves research ̶ The condition being studied and/or the purpose of the research, e.g., “an investigational drug to determine if it may improve (condition)” ̶ A summary of eligibility (inclusion/exclusion) criteria ̶ A list of potential benefits, if any ̶ Location of the research site and the contact information ̶ In all cases: use lay terminology!
Online Recruitment
Online recruitment is a tricky issue—little regulatory guidance is available on this specific topic. Although websites use a different medium than traditional print or broadcast advertisements, the requirements are the same. Consider online recruitment the same way you would a print ad or poster. If you’re using the content to recruit subjects to a specific study, it probably needs IRB approval.
Social Media
Consider how potential subjects can interact with social media platform. May be beneficial to turn off comments or closely moderate all interactions on social media platform. These interactions may affect subject privacy, potential disclosure of PHI, and misconceptions regarding the investigational product’s effectiveness.
Why DON’T Sites Use Digital Media
They can’t “own it all.” They can’t “manage it all.” They have no idea (other than anecdotal evidence) if it works (or how to tell if it works). Logistics ̶ They don’t know where or how to start. ̶ The adjustments to marketing materials appears too daunting. ̶ They’re “doing all right” without using it.
My IRB won’t approve what I need.
Owning/Managing/Logistics
Owning it all ̶ Very common theme with advertisers ̶ Go big or go home ̶ What do you buy when you use traditional media? ⋄ Metro paper or local paper ⋄ A couple TV/radio stations or every one ⋄ Billboards in traffic areas or warehouse districts
Managing it all ̶ Content has to be relevant. ̶ Somebody has to watch over it.
Logistics ̶ What sites should I use? There’s so many! ̶ Revising my materials for digital use can be challenging. ̶ Where do I find the time? Regular media placement is already laborintensive!
What Do I Look For When I Do Buy?
Designed for retail! Types of placement ̶ Impressions vs. click-throughs ̶ Auctions vs. dates
Placement ̶ Static ̶ Dynamic
Social Media ̶ Consciousness sites ̶ Network groups ̶ Blogs
Be careful what you wish for!
Content
It’s a retail space!
Working with your IRB
Realistic Expectations (November 2015 Data)
71% of companies planned to increase their digital marketing budgets this year (Source: Webbiquity) 50% of companies are using digital marketing, but they don't have a plan! (Source: Smart Insights and TFM&A) Almost half– 48%–of all emails are opened on mobile devices. Yet 39% of marketers say they have no strategy for mobile email, and only 11% of emails are optimized for mobile (Source: Adobe/Econsultancy) Over 50 trillion display ads were presented to U.S. users last year. That’s 49 trillion more than in 2010. (Source: ComScore) The typical Internet user is served 2,500 banner ads per month.
(Source:
ComScore)
Click-through rates are 0.1 percent (.001). (DoubleClick) The 468 x 60 banner has a .04 percent click rate. (.0004) (DoubleClick) 9 percent of Internet users account for 85 percent of clicks. (ComScore)
