A global pharmaceutical company approached
us to help them develop a Patient Reported
Outcome (PRO) instrument to assess diseasespecific
burden in a particular population. We
were commissioned to design and run a study
to assess the measurement characteristics of
the novel instrument and give them evidence
to back up a labeling claim. They also asked us
to develop a communications plan designed to
proactively share these important results with
clinical and patient communities.
Next
Our measurement experts developed several
programs to yield the highest quality of evidence
for sponsor stakeholders, centering on a
multiple-wave study. We ran this by re-contacting
1,250 National Health and Wellness survey
respondents. The study design gave us the ability
to generate various types of validity evidence
and test reliability for the client. The resulting
data was exhaustively analyzed using various
theoretical frameworks, including Classic True
Score Theory and Item-Response Theory.
Next
We delivered the high quality psychometric
evidence required to support our client’s regulatory
filings. Our findings were also designed to
educate and inform clinical and patient communities
about the implications of the disease
specific burden in the population. Our communication
plan was designed to ensure that they
can seize opportunities to reach out in a targeted
way to stakeholders while their clinical program
is in progress.
Next
The client commented, “Kantar Health’s
measurement experts were able to offer strong
support in an area where we have little expertise.
They really helped us decide which study options
were best for our needs, based on their strong
knowledge of prevailing scientific, regulatory
and market requirements. Their communication
plan also highlighted fresh and innovative ideas
for pursuing opportunities we had not previously
considered. They have been a true partner
throughout the project process.”