Improving Clinical Trials Through Patient Input: Outcomes of a Partnership Between
Pfizer and Parkinson’s Disease Foundation!
K. Schroeder,1 M. Feeney,1 D. Gray,2 T. Rolph,2 S. Sohur,2 and V. Todaro1 !
1) Parkinson’s Disease Foundation, a division of the Parkinson’s Foundation, New York, NY, USA and 2) Pfizer Inc., New York, NY, USA !
Objective!
To identify the outcomes of the
partnership between Pfizer and the
Parkinson’s Disease Foundation
(PDF), a division of the Parkinson’s
Foundation, designed to: 1.
increase understanding of the
patient experience; 2. better align
clinical trial protocols with this
experience; and 3. identify potential
patient reported outcome (PRO)
tools
PDF and Pfizer Partnership Outcomes !
8 PDF generated recommendations were adopted!
Resulting in 3 direct clinical trial modifications!
Identified the most
impactful non-motor
symptoms (secondary
outcomes) for people
living with Parkinson’s
disease!
Methods!
Altered PRO tools
to accurately
capture the lived
PD experience!
Sample Patient Panel Questions!
!
Seven PDF Parkinson’s Advocates
in Research (PAIR) were selected
via convenience sample by PDF
staff to participate in a one-day
patient panel. PDF Research
Advocates provided community
insights, opinions and experiences
on: challenges to functioning;
activities of daily living; and quality
of life, as well as barriers to clinical
trial participation in a series of openended questions developed by PDF
staff in partnership with Pfizer staff.
Data were transcribed and content
was analyzed using descriptive
statistics and thematic analysis.!
Clarified how
people with
Parkinson’s
disease are
defining these
symptoms!
Looking at the identified symptoms/side effects list:!
1.  What specific changes (improvements) in ____ would the
newly diagnosed like to see?!
a.  Is there something that the newly diagnosed mention
being unable or apprehensive to do, that improving
____ could allow them to do again? !
2.  How much change in ___ would demonstrate a meaningful
improvement? !
3.  What would a meaningful change in ____ look like in relation
to daily activities?!
a.  How does a person with Parkinson’s disease
measure changes in ___ in their daily lives? !
4.  Some symptom change may not be perceived or felt during a
clinical trial but can be measured. Do you think that a person
cares about a change in their symptoms if the person has not
perceived them?!
Results!
!
PDF generated a report with eight
recommendations to clarify PD
specific definitions on PRO tools; alter
PRO tools to employ a one-week
recall period; and promote positive
messaging and communications
between research sites and people
with PD to attract more people into
clinical trials. Three of these
recommendations directly resulted in
modifications to a clinical trial design.
Other insights were incorporated
indirectly. Pfizer staff viewed this
facilitated and curated interaction as
an efficient and effective way to
increase the voice of the patient in
trial design. !
Conclusion!
!
Patient advocacy organizations play a
crucial role in representing the PD
experience to more efficiently design
protocols and influence outcomes of
clinical trials. The PDF/Pfizer patient
panel project demonstrated the value
of partnerships between industry and
patient advocacy organizations. !
www. pdf.org