Limits of Advertising for Clinical Studies

1. Limits of Advertising for Clinical Studies • Regulations • Stipulations • Examples

2. Pamela Schreck, RN, MSNCoordinator, Research ServicesUniversity of Florida IRB pschreck@ufl.edu

3. The Bottom Line Time = Money Inherent conflict

4. Can the needs of the PI Correspond with the needs of the IRB?

5. Regulations—NOT specifically addressed in the regulations • U.S. Food and Drug Administration (FDA) INFORMATION sheets—guidance for institutional review boards and clinical investigators, 1998 update—available at http://www.fda.gov/oc/ohrt/irbs/default.htm • IRB Guidebook, create date: 6/27/2000—available at http://ohrp.osophs.dhhs.gov/irb/irb_chapter4.htm

6. Physician Referral Vs. Direct Advertisement Which Is the Better Approach?

7. The Presumption Has Shifted With the change within the health care setting

8. From Subject Risk Protection to Assuring Subjects Access to the Benefits of Research Participation. • Now the Belief Is: • 1. There May Be Real Benefits From Research Participation. • 2. People Ought to Have Access to Those Benefits..

9. New Approaches Raise Issues Similar to Ones That Surfaced With Direct Marketing of Prescription Drugs to the Public How Are Subject’s Rights Protected?

10. The Regulations Do NOT Apply To: • Communication intended to be seen or heard by health professionals, such as “dear doctor” letters and doctor-to-doctor letters (even when soliciting new subjects) • News stories • Publicity intended for other audiences, such as financial page advertisements directed toward prospective investors

11. Internet Advertising • IRB review is not needed when the system format limits the information provided to basic trial information, such as:

12. Title Purpose of the study Protocol summary Basic eligibility criteria Study site location(s) How to contact the site for additional information Sites not needing approval: NCI cancer clinical trial listing (PDQ) AIDS Clinical Trials Information Service (ACTIS) Basic Trial Information

13. Web Site Advertising • Must assure that it operates as a clearinghouse for information and less as a means for sponsors to attract research subjects to their studies

14. ClinicalTrials.Gov • NIH through its National Library of Medicine has developed this database to provide patients, family members and members of the public current information about clinical research studies. • This resource was initiated as a result of the FDA Modernization Act of November 1997, and the site was launched in February 2000.

15. ClinicalTrials.Gov • Legislation requires DHHS through the NIH to establish a registry of clinical trials for both federally and privately funded trials “of experimental treatments for serious or life-threatening diseases or conditions. • No registration or personal identification is required to view the listing. The information reviewed is strictly confidential. Access is free.

16. ClinicalTrials.Gov • The listing includes thousands of trials sponsored primarily by NIH and other Federal agencies. • Private industry trials are to be included later this year.

17. ClinicalTrials.Gov Submissions • Clinical trials are accepted for listing from: • Federal agencies sponsoring or supporting clinical research • Sponsors of clinical trials that have been submitted to the FDA under the IND regulations • Organizations representing IND sponsors

18. Clear Marketing Potential for Web Sites “… and it is only a short step to the look and feel of prescription drug advertising to the public’ states Jeffery Kahn.

19. When do the regulations apply? And How Do You Know?

20. Direct Advertising Guideline • Information to health care worker does not need approval from the IRB. • Information to subject does need IRB approval prior to use.

21. Direct Advertisement Requirements • The requirements apply to all direct advertising. • Always check with your IRB FIRST. Communicate the request in writing to the IRB and asking for a written response. • Keep all correspondence with your IRB in your regulatory binder.

22. Direct Advertising Considered to Be the Start of the Informed Consent and Subject Selection Process.

23. Newspaper Radio Television Bulletin Boards Posters Flyers Patient Information Letters Rosters of individuals Clinical listings Internet including email Public Service Announcement Office Memo Direct Advertising

24. Potential Subject Listing • When obtaining a listing from a third party, the investigator must consider whether any breach of confidentiality or privacy laws has occurred. For example, doctors must contact their patients for permission before releasing their names to a third party. • Investigators must ensure that approved procedures are followed by any third parties who may be aiding in the recruitment or advertising of potential subjects.

25. Stipulations Consideration should be given to the following:

26. Information That MUST Be Included in the Advertisement: • Information that the prospective subjects need to determine their eligibility and interest

27. Information That MAY Be Included: • Name and address of the clinical investigator and/or research facility; • Condition under study and/or the purpose of the research; • In summary form, the criteria that will be used to determine the eligibility for the study;

28. Additional Elements • A brief list of participation benefits, if any (e.g., a no-cost health examination); • The time or other commitment required of the subjects; and; • The location of the research and the person or office to contact for further information.

29. FDA Expectations • Should not be unduly coercive. • Does not promise a certainty of cure of other benefits beyond what is outlined in the informed consent/protocol. • No claim should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation.

30. Additional Expectations • No claim should be made that the test article is known to be equivalent or superior to any other drug, biologic or device. • The terms “new treatment” “new medication” or “new drug” should not be used without explaining that the test article is investigational.

31. “Free Medical Treatment” • Advertisements should not promise “free medical treatment” when the intent is only to say that subjects will not be charged for taking part in the investigation.

32. Florida Statutes Florida Administrative Code

33. IRB Review and Approval • Review of advertising must take place prior implementation. • Review of the FINAL copy of the advertisement must take place even if the prelimin • copy (script) has been approved.

34. Adequate Subject Protection Review • Review information contained in the advertisement. • Review the mode of communication to determine whether the procedure for recruiting subjects affords adequate protection.

35. Methods to Change the Meaning of the Message • Size of type • Other visual effects • Use of Color • Pictures • Bolding/italicized words • Cartoon characters • Spacing

36. IRB Approval • When to ask for Approval? 1) Prior to Implementation 2) Prior to Needing approval 3) Always!

42. PLAN AHEAD Follow the guidelines and ask for IRB approval before you need the advertisement.