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Advertising Research

This document discusses regulations and guidelines around advertising for clinical studies. Direct advertisement of clinical studies to potential subjects requires IRB approval. Information provided to healthcare professionals does not require approval. Acceptable information in advertisements includes basic trial details, eligibility criteria, and contact information. Advertisements cannot promise certainty of benefits or claim a product is proven safe/effective. The IRB must review advertisements to ensure adequate subject protection and that the message conveyed will not be misleading. Approval from the IRB is required prior to implementing any advertisements.

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Rahul Kolluri
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50 views

Advertising Research

This document discusses regulations and guidelines around advertising for clinical studies. Direct advertisement of clinical studies to potential subjects requires IRB approval. Information provided to healthcare professionals does not require approval. Acceptable information in advertisements includes basic trial details, eligibility criteria, and contact information. Advertisements cannot promise certainty of benefits or claim a product is proven safe/effective. The IRB must review advertisements to ensure adequate subject protection and that the message conveyed will not be misleading. Approval from the IRB is required prior to implementing any advertisements.

Uploaded by

Rahul Kolluri
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Limits of Advertising for

Clinical Studies
Regulations
Stipulations
Examples
Pamela Schreck, RN, MSN
Coordinator, Research
Services
University of Florida IRB
[email protected]
The Bottom Line
Time = Money
Inherent conflict
Can the needs of the PI
Correspond with the needs of the
IRB?
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
Physician Referral Vs. Direct
Advertisement
Which Is the Better Approach?
The Presumption Has Shifted
With the change within the health care setting
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..
New Approaches Raise Issues

Similar to Ones That Surfaced With


Direct Marketing of Prescription
Drugs to the Public
How Are Subject’s Rights
Protected?
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
Internet Advertising
IRB review is not
needed when the
system format limits
the information
provided to basic
trial information,
such as:
Basic Trial Information
Title Sites not needing
Purpose of the study approval:
Protocol summary  NCI cancer clinical
Basic eligibility criteria trial listing (PDQ)
Study site location(s)  AIDS Clinical Trials
How to contact the site Information Service
for additional (ACTIS)
information
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
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.
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.
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.
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
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.
When do the regulations
apply?
And How Do You Know?
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.
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.
Direct Advertising
Considered to Be the Start of the
Informed Consent and Subject
Selection Process.
Direct Advertising
Newspaper Rosters of
Radio individuals
Television Clinical listings
Bulletin Boards Internet including
email
Posters
Flyers Public Service
Announcement
Patient Information
Letters Office Memo
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.
Stipulations

Consideration should be given to


the following:
Included in the
Advertisement:
Information that the prospective
subjects need to determine their
eligibility and interest
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;
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.
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.
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.
“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.
Florida Statutes
Florida Administrative Code
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.
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.
Methods to Change the
Meaning of the Message
Size of type
Other visual effects
 Use of Color
 Pictures
 Bolding/italicized
words
 Cartoon characters
 Spacing
IRB Approval
When to ask for
Approval?
1) Prior to
Implementation
2) Prior to
Needing approval
3) Always!
PLAN AHEAD
Follow the guidelines and ask for
IRB approval before you need the
advertisement.

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