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Design Trials to Better Satisfy Patient Centric Outcomes Prior to Product Launch

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Incorporate Patient Participation – Design Trials to Better Satisfy Patient Centric Outcomes Prior to Product Launch
Presentation by Inspire Research Director Dave Taylor at Evidence for Value-Based Programs conference
August 12, 2015

Published in: Healthcare
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Design Trials to Better Satisfy Patient Centric Outcomes Prior to Product Launch

  1. 1. 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. 2. 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
  3. 3. Inspire Background and Panelist Introductions
  4. 4. 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. 5. 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)
  6. 6. Inspire Research Insights
  7. 7. 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. 8. 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”
  9. 9. Expert Guidance
  10. 10. 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. 11. 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?
  12. 12. Q & A

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