Patients ARE the Endpoint
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- Alexia Owen
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1 Patients ARE the Endpoint Patient Centricity Session CT Arena OCT West Coast Conference February 11, 2106 Deborah Collyar Patient Advocates In Research (PAIR)
2 How Would I Know? A 20+ year outsider Business executive (computers) Started patient advocacy in cancer research + others Advise/consult with government, academia, industry, centers, hospitals, organizations & patients E.g. development, translation, delivery/care, ethics, policy Community/public health projects Plain-language communications Thousands of patients Survivor & caregiver Writer & blogger
3 System Centers on Everything But Patients
4 Patient Centricity/Focus/Engagement/Involvement Centricity to Merriam-Webster is: 1. Located in or at the center <a centric point>. 2. Concentrated about or directed to a center <a centric activity>. 3. Of, relating to, or having a centromere. Patients Mean: Nothing about us without us!
5 Targeted care means everything Patients How to find/interest them? What/when messages received for Targeted therapies Medical misconduct Clinical trials Genetic tests/risks Partners Who will you work with? Who will work with you? What barriers exist For them? For patients?
6 We HAVE to get this right Data Knowledge Results Un-validated info harms people Bias, negative results, false+/- Wastes time/$$$, erodes trust & costs lives
7 What does PATIENT mean to you?
8 Patients view of PATIENT A whole person who has a disease/condition.
9 Patients Want a Whole Medical Answer in Context Emotional Family Financial FUTURE Social Interactive Work
10 Example of Patient Centric approach Diabetic care Arena OCT West Coast Patient Centricity Penal Discussion February Yu Ping Yen, PhD VP, Clinical Operations
11 Diabetic Management Great example of Patient Centric approach! Transforming the treatment of diabetes Diet and exercise at initial diagnosis Complex treatment regimens as disease progresses Treatment guidances focus on individualized, patient-centric care, and shared decision making Patient s attitudes and willingness/able to make life-style changes (e.g., controlling obesity, smoking, exercise & diet) Risk factors Obesity Duration of disease Life expectancy Comorbidities (e.g., hypoglycemia, cardiovascular conditions, etc..) Support system and economic burden 11 confidential
12 Therapy in type 2 diabetes: general recommendations Dance 501, instead of basal insulin, added to metformin offers the potential of better efficacy by lowering postprandial glucose and improving compliance, both significant problems in T2DM 2015 by American Diabetes Association Adapted from American Diabetes Association Diabetic Care 2015;38:S41-S48
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14 Individualized approach: One-size does not fit all Transforming the treatment of diabetes 14 confidential
15 FDA welcomes patient voice: Stayce Beck at D-Data Exchange 2015 on webcast town hall meetings Transforming the treatment of diabetes 15 confidential
16 Patient Advocates In Research (PAIR) Where Research meets Reality Patient-focused peers = Partners Patient experiences/issues into research Practice respectful irreverence Resolve research barriers Relevance for results
17 Advocates represent patients Concept/protocol design & review >> feasibility Endpoints, adaptive design, crossovers Eligibility & test procedures FDA, all phases, collaborators, etc. >> speed Ethics/Institutions Review Boards >> risk Accrual plans & materials >> understanding Communities and populations >> influence Plain language summaries >> results
18 What Does It Take? Jargon-free communication Ground rules for open exchange Plan together Clinical trials for people, not careers Share emerging research issues Adjust often
19 + Leave egos & chips at door
20 Help find solutions, not stopgaps Patient failed the treatment NEVER happens. Treatment failed the patient too often. Let s find answers so our kids won t have to
21 Thanks for all you do for patients and their Blog:
How we can make clinical trials better for & with people & patients
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