Patient Advocacy Panel: Incorporate Patient Participation – Design Trials to Better Satisfy Patient Centric Outcomes Prior to Product Launch

Evidence for Value-Based Programs August 12, 2015

2

►  Inspire Background and Panelist Introductions

►  Inspire Research Insights

•  Clinical Trial Design Considerations

•  Case Study: One More Lung Biopsy

► Structured, Expert Guidance

► Q & A

Agenda

5 minutes

5 minutes

10 minutes

20 minutes

Inspire Background and Panelist Introductions

4

Inspire Background

Social network for PTs and CGs:

• ~648,000 members • 200+ communities • ~110 advocacy org. partners

‘Born’ in 2005

Live in 2006

Member growth through:

• Organic search

• Advocacy groups

• Miscellaneous

Goal was to connect patients & caregivers

with one another

AND connect them directly with pharma

(clinical trials)

5

Panelist Introductions

Linnea Duff

Advanced Lung Cancer Survivor

Advocate & Blogger

twitter.com/1111linno

outlivinglungcancer.com

Kari Luther Rosbeck

President and CEO

Tuberous Sclerosis Alliance

>2,800 members in TS

Alliance Support Community

Melanie Vogel

Mother and ‘caregiver’ to daughter, Riley with TSC

Riley has participated in clinical trials since Dx at

17 months old

Founder of Rock 4 Riley (rock4riley.org)

Inspire Research Insights

7

Clinical Trial Design Considerations A while back, we were asked by a pharma partner to assess patient willingness to participate in one of two clinical trial designs for IBD,

each of which had unique testing requirements

- Trial Design #1: 6-month trial in which patient would have to collect anywhere from 2 to 6+ stool samples during that time

- Trial Design #2: 6-month trial in which patient would have to have 2 endoscopies performed (one at the start and one at the end of the trial)

37%  

54%  

Overall, those who were ‘sicker’ (not in remission at

time of study, have had more flares in past year)

were:

1)  More willing to participate, and

2)  More willing to ‘do

more’ for the study

VALUE

8

Case Study: One More Lung Biopsy

In some recent work we’ve done in NSCLC, our pharma partner wanted to

know if patients would be willing to undergo another lung biopsy if a new

genetic/biomarker test became available that could inform additional treatment

options

Despite several having complications with their previous biopsies (e.g.,

collapsed lung, infection, etc.), most would consider the test

VALUE

At the Patient Adherence and Access Summit in June, we took a close look at

the word “adherence”

“Adherence” and “compliance” represent authoritative concepts, subliminally

elevating the HCP over their patients

We recognized the need for more patient-centric concepts such as “ownership” and “engagement”

In this session, we need to evaluate the word “value” which has been used in the

context of pharma and providers

Deliver patients and their loved ones their ‘WIIFM’ à “hope”, “outcomes”

“quality of life”

Expert Guidance

10

Overcoming Obstacles Before & During Clinical Trials

“If you show up regularly, you adhere”

ASCO paying HCPs $350/patient for those who stay

compliant with protocol

Food for thought: -  Setting expectations going into a

clinical trial -  What keeps patients coming back

for the trial -  What issues might a patient have

with: -  Trial center accessibility -  Finances (travel costs, etc.) -  Check-ins and evaluations -  Overall satisfaction -  Treatment satisfaction -  Quality of life

-  What improvements can be made to make clinical trial participation more manageable

11

True Patient-Centric Design: Early and Often

Food for thought: -  How can patients aid with the development of patient-reported

outcome tools and measurements? -  What should be the role patients play in helping to develop these

surveys/questionnaires?

In one of yesterday’s sessions, there was a graphic which showed “Patient-centered endpoints” listed under Phase III of the new product

development cycle

-  When should patients be involved in this process?

Q & A