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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

Methods!!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 open-ended questions developed by PDF staff in partnership with Pfizer staff. Data were transcribed and content was analyzed using descriptive statistics and thematic analysis.!

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. !

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!

Clarified how people with Parkinson’s disease are

defining these symptoms!

Altered PRO tools to accurately

capture the lived PD experience!

Sample Patient Panel Questions!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?!

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. !