Abstract:
BACKGROUND:Formal incorporation of patients' perspectives is becoming increasingly important in medical product development and decision making. This article shares practical advice regarding how patient advocacy organizations, the pharmaceutical industry, and academic experts in stated-preference research can effectively partner on benefit-risk patient preference studies. METHODS:The authors partnered on a benefit-risk patient preference study related to the treatment of psoriasis. The authors from Duke Clinical Research Institute also share their experiences in collaborating with numerous other organizations in conducting benefit-risk patient preference studies. RESULTS:Upon initiation of the study partnership with appropriate experts, training is important to ensure all collaborators have a common understanding of the methodology, what objectives stated-preference methods can support, and expectations for the project. To the extent possible, partners should align on and document relevant clinical and logistical details prior to study implementation. During study implementation, partners should use good communication practices and document and maintain a record of any changes to the original plan. Presentation of the study results should be tailored to the particular audience, with the appropriate partner leading the presentation based on its format and audience. CONCLUSION:Partners from patient advocacy organizations, the pharmaceutical industry, and academia can effectively collaborate on benefit-risk patient preference studies with sufficient planning and ongoing communication. This article is a call for action for other organizations to engage in sharing of experiences regarding effective partnering in quantifying patient preferences in medical product development.
journal_name
Ther Innov Regul Scijournal_title
Therapeutic innovation & regulatory scienceauthors
Wolka AM,Fairchild AO,Reed SD,Anglin G,Johnson FR,Siegel M,Noel Rdoi
10.1177/2168479017746404subject
Has Abstractpub_date
2018-07-01 00:00:00pages
507-513issue
4eissn
2168-4790issn
2168-4804journal_volume
52pub_type
杂志文章abstract:BACKGROUND:The coherence between the relationship of QTc and drug plasma concentration (this relationship is measured through the slope) and ICH E14 findings based on hundreds of QT study reports was studied. RESULTS:Based on ICH E14 analysis, our findings indicate that if the slope was not positive, in most cases (86...
journal_title:Therapeutic innovation & regulatory science
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doi:10.1177/2168479014563549
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abstract::Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under which preapproval a...
journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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abstract:BACKGROUND:Although a large number of clinical trials have been conducted, the types of clinical trials that are scientifically influential, frequently utilized by society, and contribute to the progress of evidence-based medicine (EBM) have not been studied. Thus, we aimed to investigate the relationship between the c...
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journal_title:Therapeutic innovation & regulatory science
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abstract:BACKGROUND:According to 21 Code of Federal Regulation (CFR) Part 211, Over-the-Counter (OTC) drug manufacturers must establish and follow current good manufacturing practices (cGMP) to produce quality products while meeting regulatory standards. The warning letters issued by the U.S. Food and Drug Administration (FDA) ...
journal_title:Therapeutic innovation & regulatory science
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更新日期:2016-09-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2019-07-16 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2019-03-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2020-01-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2020-09-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2013-03-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2016-03-01 00:00:00
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journal_title:Therapeutic innovation & regulatory science
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更新日期:2020-09-01 00:00:00