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Clinical trial endpoints - e-Patient Dave ESMO 2014

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e-Patient Dave deBronkart
e-Patient Dave deBronkart

A very different presentation from my usual - 10 minutes about letting patients help make decisions about WHAT get studied in clinical trials

Health & Medicine
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Meaningful JAMIA, 1997 Patient Involvement in Clinical Trial Endpoints “e-Patient Dave” deBronkart Twitter: @ePatientDave facebook.com / ePatientDave LinkedIn.com / in / ePatientDave dave@epatientdave.com Skype: ePatientDave Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using Angela Coulter
Paternalistic caring Sensible – up to a point “No, honey – you don’t know what you need.” “I’ll take care of you.” “I’ll decide for you.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using Zoe When does autonomy become appropriate?
Empowerment “An empowering approach to participation treats poor people as co-producers with authority and control over decisions and resources devolved to the lowest appropriate level.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using World Bank’s definition
Empowerment “An empowering approach to participation treats poor people as co-producers with authority and control over decisions and resources devolved to the lowest appropriate level.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Empowerment “An empowering approach to participation treats patients as co-producers with authority and control over decisions and resources devolved to the lowest appropriate level.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Institute of Medicine – Sept 2012 Major New Report: “Best Care at Lower Cost” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Yes, the IOM itself says e-patients are an essential part of tomorrow’s healthcare. Patient-Clinician Partnerships Engaged, empowered patients— A learning health care system is anchored on patient needs and perspectives and promotes the inclusion of patients, families, and other caregivers as vital members of the continuously learning care team. Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Who gets to say which outcomes are important?? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Who gets to say which outcomes should be goals? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Who gets to declare which endpoint we measure? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Who gets to say what’s in the patient’s best interest? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Paternalistic caring Sensible – up to a point “No, honey – you don’t know what you need.” “I’ll take care of you.” “I’ll decide for you.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
I predict a new battlefield: time versus certainty Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
To the scientist, the time when we find the truth is irrelevant to its worth. Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
But to a patient with a progressive disease, time is everything Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Time Value of Money “A dollar today is worth more than a dollar next year” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Patients are proposing there’s a Time Value of a Treatment “A treatment today is worth more than the same treatment next year” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
For patients with a progressive disease … “A treatment today may be worth more than a better treatment next year” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
What factors are worth tracking as a patient’s condition and development of a treatment proceed separately but simultaneously? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Factors in an equation for the time value of a treatment • Efficacy – We assume efficacy will improve as we continue developing and testing the intervention • Certainty of the benefit (low p) – More studies, and improvements in development, should improve certainty over time • Utility to the patient (need, benefit, etc) Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Time Value of a Treatment as time progresses : Vtx,t = f(efficacyt, certaintyt, ut) Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Scientists quantify efficacy and certainty. Only the individual patient can assess the utility. Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
June 11, 2014 www.bmj.com/content/348/bmj.g3726 Announced – • Patient advisory panel • Patient peer review of research papers • Authors are to document how they involved patients in defining the question and outcome measures Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
Meaningful JAMIA, 1997 Patient Involvement in Clinical Trial Endpoints “e-Patient Dave” deBronkart Twitter: @ePatientDave facebook.com / ePatientDave LinkedIn.com / in / ePatientDave dave@epatientdave.com Skype: ePatientDave Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using

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Clinical trial endpoints - e-Patient Dave ESMO 2014

  • 1. Meaningful JAMIA, 1997 Patient Involvement in Clinical Trial Endpoints “e-Patient Dave” deBronkart Twitter: @ePatientDave facebook.com / ePatientDave LinkedIn.com / in / ePatientDave dave@epatientdave.com Skype: ePatientDave Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 2. Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using Angela Coulter
  • 3. Paternalistic caring Sensible – up to a point “No, honey – you don’t know what you need.” “I’ll take care of you.” “I’ll decide for you.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 4. Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using Zoe When does autonomy become appropriate?
  • 5. Empowerment “An empowering approach to participation treats poor people as co-producers with authority and control over decisions and resources devolved to the lowest appropriate level.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using World Bank’s definition
  • 6. Empowerment “An empowering approach to participation treats poor people as co-producers with authority and control over decisions and resources devolved to the lowest appropriate level.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 7. Empowerment “An empowering approach to participation treats patients as co-producers with authority and control over decisions and resources devolved to the lowest appropriate level.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 8. Institute of Medicine – Sept 2012 Major New Report: “Best Care at Lower Cost” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 9. Yes, the IOM itself says e-patients are an essential part of tomorrow’s healthcare. Patient-Clinician Partnerships Engaged, empowered patients— A learning health care system is anchored on patient needs and perspectives and promotes the inclusion of patients, families, and other caregivers as vital members of the continuously learning care team. Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 10. Who gets to say which outcomes are important?? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 11. Who gets to say which outcomes should be goals? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 12. Who gets to declare which endpoint we measure? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 13. Who gets to say what’s in the patient’s best interest? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 14. Paternalistic caring Sensible – up to a point “No, honey – you don’t know what you need.” “I’ll take care of you.” “I’ll decide for you.” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 15. I predict a new battlefield: time versus certainty Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 16. To the scientist, the time when we find the truth is irrelevant to its worth. Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 17. But to a patient with a progressive disease, time is everything Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 18. Time Value of Money “A dollar today is worth more than a dollar next year” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 19. Patients are proposing there’s a Time Value of a Treatment “A treatment today is worth more than the same treatment next year” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 20. For patients with a progressive disease … “A treatment today may be worth more than a better treatment next year” Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 21. What factors are worth tracking as a patient’s condition and development of a treatment proceed separately but simultaneously? Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 22. Factors in an equation for the time value of a treatment • Efficacy – We assume efficacy will improve as we continue developing and testing the intervention • Certainty of the benefit (low p) – More studies, and improvements in development, should improve certainty over time • Utility to the patient (need, benefit, etc) Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 23. Time Value of a Treatment as time progresses : Vtx,t = f(efficacyt, certaintyt, ut) Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 24. Scientists quantify efficacy and certainty. Only the individual patient can assess the utility. Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 25. June 11, 2014 www.bmj.com/content/348/bmj.g3726 Announced – • Patient advisory panel • Patient peer review of research papers • Authors are to document how they involved patients in defining the question and outcome measures Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using
  • 26. Meaningful JAMIA, 1997 Patient Involvement in Clinical Trial Endpoints “e-Patient Dave” deBronkart Twitter: @ePatientDave facebook.com / ePatientDave LinkedIn.com / in / ePatientDave dave@epatientdave.com Skype: ePatientDave Copyright © 2013 e-Patient Dave Please contact via epatientdave.com before re-using