Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 427)

Section 12: Patient Recruitment 12.1 Q. Increasingly, sponsors and clinical sites are employing social media tools such as YouTube, Facebook, and Twitter to aid clinical trial awareness and enrollment. Given the speed with which trial-related information can be posted and updated on such tools, how are sites ensuring that IRB review and approval processes do not undermine the advantages that the immediacy such tools can offer? A. There is little question that many sophisticated study sites are increasingly leveraging the advantages of social media tools to aid trial-recruitment efforts. There is also no question that some sites have struggled to ensure that the demands of, and the time involved in, routine IRB reviews do not undermine the value that Internet postings can offer. In early 2011, the emerging experiences of The University of Texas’ M.D. Anderson Cancer Center continued to illustrate the value that social media can bring to the trial process (Skoler, “IRB Approval a Factor in Using Social Media in Recruitment,” Clinical Trials Advisor, December 10, 2009, Vol. 14, No. 24), and provide a fascinating example of how sites can work cooperatively with their IRBs in this area. In fact, industry experts predict that the M.D. Anderson model for developing social media trial recruitment efforts and addressing IRB review requirements will be widely imitated going forward. The cancer center first tried social media in early 2007, after email initiatives failed to help its flagging recruitment efforts to enroll subjects for Hodgkin’s lymphoma trials. Today, however, the center has a robust social media program (a Facebook page with 8,941 users by late 2010, up from about 2,000 users a year earlier), YouTube video posts educating patients on trial goals and specifics, regular clinical investigator “tweets” that link to study-related information and a Q&A web page, and information sharing on Delicious (a social bookmarking tool), and has seen its enrollment rate for patients with relapsed Hodgkin’s lymphoma quadruple to 80 subjects a year. Perhaps not surprisingly, the success that the cancer center has experienced in using social media for lymphoma trials spread throughout the center during 2010. Over the last several months, faculty in at least ten different departments within M.D. Anderson are now beginning to use social media outlets to help raise awareness for available clinical trials. While the center’s approach to gaining IRB review and approval of its social media content has been portrayed by some as an “expedited process,” Jennifer Texada, M.D. Anderson’s digital and new media program manager, describes it as more of a “singular process” in which her group attempts to identify, in advance, all the social media content that will be associated with a trial and to obtain IRB approval for all of this content at once. The cancer center defines social media as: (1) any content that exists outside M.D. Anderson’s clinical trials website/landing page (e.g., tweets, etc.), but that may be used to create awareness of the website/landing page content and drive traffic there; and (2) any content on which there can be two-way communication (e.g., Delicious bookmark or YouTube postings, since viewers can post information and comments in response to the posting). Texada also notes that she also employs “simple content language” and attempts to get multiple versions of social media content language approved by the IRB in a “block.” Doing so, she notes, “extends the life” of the IRB approval for social media, and circumvents the need for the center to continually go back to its IRB for alternate language or updating. More recently, Texada points out that her group has adopted an approach based on early IRB involvement in the development of certain content for which IRB approval had been extremely challenging in the past. In some cases, for example, her digital and new media group is asked to help produce video or audio content designed to support clinical trial recruitment efforts. To help gain the trust of the IRB and to speed the approval process later, Texada has found that forwarding to the IRB the question list or script for the video/audio content before the final product is developed has helped to ensure IRB approval in the future. An important aspect to the success of social media at M.D. Anderson, Texada notes, was reaching “an understanding” with the IRB as to the nature of the content used in social media—in other words, which content is for education only, which is for marketing, and which is a combination of the two. Otherwise, she notes, all content will be viewed and reviewed by the IRB as marketing-related content and be subjected to the same level of scrutiny. 427

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2012

Good Clinical Practice: A Question & Answer Reference Guide - May 2012
Table of Contents
Introduction
Section 1: GCP Regulations, Standards and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Form FDA-1572/Statement of the Investigator
Section 4: Study Sponsors and Clinical Trial Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing
Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Section 15: Drug Accountability, Administration, and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection
Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, China, Russia, Ukraine, and India
Section 20: GCP Compliance Statistics and Trends
21 CFR Part 11 — Electronic Records; Electronic Signatures
21 CFR Part 50 — Protection of Human Subjects
21 CFR Part 54 — Financial Disclosure by Clinical Investigators
21 CFR Part 56 — Institutional Review Boards
21 CFR Part 312 — Investigational New Drug Application
ICH Consolidated Guideline on Good Clinical Practice (E6)
ICH Guideline on Clinical Safety Data Management (E2A)
European Union Clinical Trials Directive
European Union Good Clinical Practice Directive

Good Clinical Practice: A Question & Answer Reference Guide - May 2012