Patient-Centeredness in the Design of Clinical Trials

Mullins, C. Daniel; Vandigo, Joseph; Zheng, Zhiyuan; Wicks, Paul

doi:10.1016/j.jval.2014.02.012

Cited by 78 publications

(77 citation statements)

References 15 publications

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“…In addition, payers are looking for evidence from studies on patient perspectives to support deliberations around the value proposition of new therapies, and some have established organizations, including the Patient Centred Outcomes Research Institute in the United States, to ensure such evidence is generated. [17][18][19] In this article, we describe one approach to incorporating patients' perspectives into the design of cardiovascular clinical trials involving composite end points.…”

mentioning

confidence: 99%

Incorporating patient preferences into clinical trial design: Results of the Opinions of Patients on Treatment Implications of New Studies (OPTIONS) project

Stafinski

Menon

Nardelli

et al. 2015

American Heart Journal

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mentioning

confidence: 99%

Incorporating patient preferences into clinical trial design: Results of the Opinions of Patients on Treatment Implications of New Studies (OPTIONS) project

Stafinski

Menon

Nardelli

et al. 2015

American Heart Journal

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“…Although this has been recognized and recommended for many years, the lay representation on research ethics committees has often been limited or nonexistent [26]. Such representation should, for neonatal studies, include resource parent voices.…”

Section: Historymentioning

confidence: 99%

Integrating Parents in Neonatal and Pediatric Research

et al. 2019

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Background: Parents and their infants are the beneficiaries of neonatal and pediatric research, but in the past they have been excluded from most stages of research projects. As a result, many projects may fail to produce the most worthwhile information for parents and families. Lately, veteran resource parents and patients have been increasingly integrated in research initiatives. Methods: Benchmarking of neonatal and pediatric research initiatives where resource parents and/or ex neonatal patients have helped to optimize pediatric research. We review ways in which resource parents/patients can be involved in research, with examples and practical ideas of how to proceed. Results: Resource parents/patients can be collaborators in research and be integrated in many steps: prioritizing research projects, designing trials, determining the outcomes of interest, ethics review, developing and improving consent procedures, collection and interpretation of data, participation in data safety monitoring committees, publication of results, and presentation to peer groups. Some of the strategies for integration of stakeholders in clinical research are more complex, may involve risk and require more training than others. Conclusion: We suggest that groups wanting to involve parents in their research endeavors start with simpler tasks that entail less risk and develop teams of resource parents who have differing interests and abilities. Quality control of programs is essential, such as frequently giving and obtaining feedback from resource parents/patients and researchers. In the future, integration of resource parents/patients into every step of clinical research will be essential to ensure that parent and family important outcomes are examined.

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“…However, patients might suggest that these blood draws could be done at an external lab close to the patient's neighborhood and this lab could then relay the results to the research site, significantly reducing the time and travel burden on patients [20]. Using such approaches to make the trial more patient-centered could potentially help reduce patient drop out from CER trials [21].…”

Section: Conducting the Studymentioning

confidence: 99%

Continuous patient engagement in cardiovascular disease clinical comparative effectiveness research

Vandigo

Oloyede

Aly

et al. 2016

Expert Review of Pharmacoeconomics & Outcomes Research

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Researchers have produced evidence that identifies interventions that reduce cardiovascular disease (CVD) risk; however, despite a significant investment in research CVD remains the leading cause of death. Engaging patients in the research process has the potential to ensure that evidence-based treatments are adopted in real-world practice to improve patient outcomes. The Patient-Centered Outcomes Research Institute has created an Engagement Rubric to guide meaningful engagement in the research process. A 10-step systematic framework to enhance patient engagement throughout the comparative effectiveness research process also has been proposed. This special report identifies the relationship between these two approaches to patient engagement and describes examples of how patients could be engaged in a hypothetical CVD study.

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Patient-Centeredness in the Design of Clinical Trials

Cited by 78 publications

References 15 publications

Incorporating patient preferences into clinical trial design: Results of the Opinions of Patients on Treatment Implications of New Studies (OPTIONS) project

Incorporating patient preferences into clinical trial design: Results of the Opinions of Patients on Treatment Implications of New Studies (OPTIONS) project

Integrating Parents in Neonatal and Pediatric Research

Continuous patient engagement in cardiovascular disease clinical comparative effectiveness research

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