Transcript Slide 1

Message
communication vs.
data dumping
How to write effectively for your audience
Karin Hawkinson, Scientific Director,
Global Market Access Communications
© 2015 Evidera.
All Rights Reserved.
Today’s discussion
 Getting started
– Key questions to make sure your document
is on track
 Getting your message across
– Selecting and translating information
– Making the format work for you
– Incorporating the ‘so what’
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Getting started
Key questions to make sure your document
is on track
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Focus on your goal
 What is the goal of a value dossier?
– Compelling value story
– Best available evidence
 Includes the key
components
of the value story
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Consider your audience
 Internal pharma company affiliates,
who then use/revise for an external audience
 External payers, decision makers,
and clinical advisors
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The risk of data dumping
 Forgetting your goal and audience
can lead to a data dump:
– Is a collection of facts
without context or
perspective
– Does not incorporate
what the information
means or why it is
relevant
– Lacks the ‘so what’
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What are our clients looking for?
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Provide the SO WHAT
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Getting your message across
Selecting and translating information
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Present what is relevant…
 Focus on the value story
 What distinguishes the
product
 What is needed for each
topic for the audience
 Talk to your client
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Relevance is relative
 Consider whether the information is relevant
to your specific product
 Consider relevance on a more global level
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Translate the information
Original
Revised
DLQI scores: At 16 weeks, the
mean change in DLQI was −6.9 for
the 5-mg dose and −8.9 for the 10mg dose versus 1.3 for placebo.
DLQI scores: Patients treated with
[drug] 5 mg and 10 mg reported
greater improvement in the DLQI
score than patients treated with
placebo. At 16 weeks, the mean
DLQI improved by 6.9 points for the
5-mg dose and by 8.9 points for
the 10-mg dose, and worsened by
1.3 points with placebo.
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Selecting and translating facilitates
original writing
 Presenting information with selecting for relevance
and without translating can lead to lifting text from a
source
 Our clients hire us for our writing skills and expect
original writing that accurately reflects the source
 Ways to ensure translation
–
–
–
–
–
What is relevant
List key points and rework from there
Pretend you need to cut the text in half and rework
Present the information differently
Acquire the necessary knowledge
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Getting your message across
Making the format work for you
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The organization and structure should
support your message
 Does your structure:
–
–
–
–
Segment the information into appropriate chunks?
Do the segments follow a logical order?
Do you show the relationships among segments?
Provide a home for all relevant information?
 Have a place for everything that is relevant
 If something doesn’t seem to fit the flow, that
may be a clue it should not be there
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Some organization strategies
 Group similar information in a table,
where the data can be compared
 Move more detailed information to an appendix
 Consider adding section summaries
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Getting your message across
Incorporating the ‘so what’
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Provide the ‘SO WHAT’
 The most important technique to develop an
effective dossier that is not merely a data repository
– Helps winnow down the information to what is relevant
– Forces you to translate the information and provide the
perspective that supports your value messages
 Provide it
appropriately
for your
audience
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Describe the consequences
Original
Revised
[Drug] 5 mg and [Drug] 10 mg were
superior to placebo in achieving
NAPSI 75 and resulted in greater
improvements in DLQI and ISI.
[Drug] 5 mg and [Drug] 10 mg were
superior to placebo in achieving
NAPSI 75, reflecting a significant
reduction in the symptoms of nail
psoriasis, and in improving ISI
scores, reflecting a reduction in
itching. Both doses also improved
DLQI scores, providing
improvements in dermatologic and
health-related quality of life.
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Provide the context
 Study design information
Study 1 included patients with moderate to severe COPD
(excluded GOLD IV patients). Patients who had previously
been on a long-acting bronchodilator (LABA) or a
LABA/inhaled corticosteroid fixed-dose combination
(LABA/ICS FDC) had to cease therapy before the run-in
period.
 The ‘so what’
By excluding LABAs and LABA/ICS FDCs and not covering
GOLD IV patients, the efficacy of [Drug] was tested in a
patient population that does not represent “real-life”
patients; the included population is also likely to lead to
better lung function responses
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Pharmacokinetics and statistics
need context
 Pharmacokinetic data are frequently presented
without any context
– Make sure any PK value you provide is relevant
– Translate what each PK value means in terms of what
happens to the drug and the consequences
 Statistics and analysis populations usually need
explained
– Explanations can help bolster the credibility of the
results and provide context
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Explain the background
Trial
Description
Study 1 Comparison of the PK and PD profiles of [New Insulin] vs US-approved [Insulin Z]
Study 2 Comparison of the PK and PD profiles of [New Insulin] vs EU-approved [Insulin Z]
Explanation
The comparator used throughout the clinical development program, [Insulin Z]
has been approved and marketed in both the US and the EU. While the USapproved and EU-approved products are not known to differ with respect to
their clinical pharmacologic properties, the possibility of any such differences
was taken into consideration in the clinical program. Separate phase 1 PK/PD
trials were conducted to compare [New Insulin] to each [Insulin Z] product
independently. In addition, a phase 1 PK/PD trial was conducted to compare
the US-approved and EU-approved [Insulin Z] products to each other.
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Make the connections
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In closing
 Providing the context and perspective that will help
your readers understand why the information is
important and what it means is THE most important
technique you can use to develop an effective
dossier that is not merely a data repository
 Remind yourself of the goal and audience
 Ask yourself:
• What information is relevant and how can I translate it for
my audience?
• Is it presented in a fashion that is helpful to a reader and
supports the overall story?
• What does it mean?
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