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In our third published document on the topic
of Adverse Event Reporting (AER), we explore an issue that was touched
on only briefly in our first AER discussion back in October. That is,
the measures some pharmaceutical companies are taking to manipulate
marketing research efforts in order to prevent respondents from producing
information that would constitute a reportable Adverse Event (AE), and
therefore, reduce a company's own risk. For example, from conversations
we have had with clients and our researchers who are out in the field,
we have learned that several pharmaceutical companies have assembled
questionnaire review committees to ensure that questions likely to produce
the report of AEs are purged from questionnaires before they are fielded.
Other companies are strategically selecting or avoiding certain research
methodologies based on their likelihood of producing a reportable AE.
Clearly, these circumstances show that we are moving away from an era
in which meeting a project’s marketing research objectives was
the major driver of methodology selection toward an era in which minimizing
the risk of hearing an AE reported weighs greatly in selecting the methodology.
This movement not only substantially reduces the value of the data collected
through marketing research projects, but also actually diminishes the
ability of marketing research to contribute to the safety vigilance
process. While we would certainly never suggest that a pharmaceutical
company go looking for trouble, we do strongly recommend against using
any other criteria except methodological appropriateness as a factor
in selecting the approach(es) to be taken in a particular research project.
To download the December 2006 discussion on AER, click the link on the
graphic image above.
As discussed in previous issues of Topline,
a critical component of the GfK U.S. Healthcare Companies’ AER
policy is an internal training program that will ensure a thorough and
consistent foundation of education on the issue of AER for all 275 GfK
U.S. Healthcare Companies’ employees.
It is important to note here that we do not expect our training to supplant
our clients’ own company training procedures. Rather, given the
fact that we have received, and anticipate we will continue to receive,
a number of different training modules from various pharmaceutical companies,
we felt it important to create an internal training program that will
provide a unified backdrop for – not a replacement of –
our clients’ valuable efforts.
We are pleased to report that in November, each employee received the
first of two AER training DVDs that will be distributed over the next
year. This inaugural DVD provides a general overview of the topic of
AER and reviews the GfK U.S. Healthcare Companies’ policy and
procedures for notifying our clients about AEs encountered during research.
Along with the DVD, each employee was provided a contract that he/she
must sign verifying that he/she has watched the DVD and therefore, completed
the training. This contract will be kept on file for internal archiving
purposes and may be provided to clients, upon request, as verification
that a researcher has undergone the GfK U.S. Healthcare Companies’
training.
We will keep you informed via Topline as future installments
of the training DVDs are distributed to our employees and would be pleased
to share these DVDs with you so you can better understand what our employees
are learning about AER.
If you would like to receive a complimentary copy of the November 2006
AER training DVD, featuring Group Chief Executive Officer of the GfK
U.S. Healthcare Companies, Richard B. Vanderveer, Ph.D., please fill
out the form below.
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