Skip to main content
Top
Published in: The Patient - Patient-Centered Outcomes Research 4/2017

01-08-2017 | Commentary

Giving Patients a Meaningful Voice in United States Regulatory Decision Making: The Role for Health Preference Research

Authors: F. Reed Johnson, Kathleen Beusterien, Semra Özdemir, Leslie Wilson

Published in: The Patient - Patient-Centered Outcomes Research | Issue 4/2017

Login to get access

Excerpt

Weighing the benefits and risks of new health technologies requires assessing the available scientific evidence but also making societal value judgments about the relative importance of those benefits and risks [1]. Such judgments traditionally have been delegated to physicians. Increasingly, however, patients are claiming a greater role in such assessments. This paper discusses the increasing concern of the US FDA in strengthening patient engagement by conducting health preference research (HPR) on patients’ risk tolerance. …
Literature
1.
go back to reference Hammad TA, Neyarapally GA, Iyasu S, Staffa JA, Del Pan G. The future of population-based postmarket drug risk assessment: a regulator’s perspective. Clin Pharmacol Ther. 2013;94(3):349–58.CrossRef Hammad TA, Neyarapally GA, Iyasu S, Staffa JA, Del Pan G. The future of population-based postmarket drug risk assessment: a regulator’s perspective. Clin Pharmacol Ther. 2013;94(3):349–58.CrossRef
3.
go back to reference Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013–2015. Fed Regist. 2013;78:21613–4. Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013–2015. Fed Regist. 2013;78:21613–4.
7.
go back to reference US Department of Health and Human Services, FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Guidance for Industry and Food and Drug Administration Staff: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. March 28, 2012. Available at https://duke.box.com/s/rrllbrq57b8imsdb9uv1ys5qdfudm94p. Accessed 1 June 2017. US Department of Health and Human Services, FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Guidance for Industry and Food and Drug Administration Staff: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. March 28, 2012. Available at https://​duke.​box.​com/​s/​rrllbrq57b8imsdb​9uv1ys5qdfudm94p​. Accessed 1 June 2017.
9.
go back to reference Ho MP, Gonzalez JM, Lerner HP, Neuland CY, Whang JM, McMurry-Heath M, Hauber AB, Irony T. Incorporating patient-preference evidence into regulatory decision making. Surg Endosc. 2015;29(10):2984–93.CrossRef Ho MP, Gonzalez JM, Lerner HP, Neuland CY, Whang JM, McMurry-Heath M, Hauber AB, Irony T. Incorporating patient-preference evidence into regulatory decision making. Surg Endosc. 2015;29(10):2984–93.CrossRef
11.
go back to reference Frederiks ER, Stenner K, Hobman EV. Household energy use: applying behavioural economics to understand consumer decision-making and behaviour. Renew Sustain Energy Rev. 2015;41:1385–94.CrossRef Frederiks ER, Stenner K, Hobman EV. Household energy use: applying behavioural economics to understand consumer decision-making and behaviour. Renew Sustain Energy Rev. 2015;41:1385–94.CrossRef
12.
go back to reference Cialdini RB, Trost MR. Social influence: social norms, conformity and compliance. In: Gilbert DT, Fiske ST, Lindzey G, editors. The handbook of social psychology. 4th ed. New York: McGraw-Hill; 1998. p. 151–92. Cialdini RB, Trost MR. Social influence: social norms, conformity and compliance. In: Gilbert DT, Fiske ST, Lindzey G, editors. The handbook of social psychology. 4th ed. New York: McGraw-Hill; 1998. p. 151–92.
13.
go back to reference Bridges JFP, Hauber AB, Marshal D, Lloyd A, Prosser LA, Regier DA, Johnson FR, Mauskopf J. Conjoint analysis applications in health—a checklist: a report of the ISPOR good research practices for conjoint analysis task force. Value Health. 2011;14:402–13.CrossRef Bridges JFP, Hauber AB, Marshal D, Lloyd A, Prosser LA, Regier DA, Johnson FR, Mauskopf J. Conjoint analysis applications in health—a checklist: a report of the ISPOR good research practices for conjoint analysis task force. Value Health. 2011;14:402–13.CrossRef
Metadata
Title
Giving Patients a Meaningful Voice in United States Regulatory Decision Making: The Role for Health Preference Research
Authors
F. Reed Johnson
Kathleen Beusterien
Semra Özdemir
Leslie Wilson
Publication date
01-08-2017
Publisher
Springer International Publishing
Published in
The Patient - Patient-Centered Outcomes Research / Issue 4/2017
Print ISSN: 1178-1653
Electronic ISSN: 1178-1661
DOI
https://doi.org/10.1007/s40271-017-0250-z

Other articles of this Issue 4/2017

The Patient - Patient-Centered Outcomes Research 4/2017 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine