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More info
You can access this
clinical trial
if you have
Type II Diabetes
and you are
over 18
years old
-
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify the principal benefit-risk factors FDA considers during the reviews for premarket approval applications and de novo classification requests. In addition to a detailed description of benefits and risks, CDRH listed "patient tolerance for risk and perspective on benefit" as a factor that CDRH may consider in regulatory reviews. It underlined the need for developing methods to measure patient preference and incorporate it into regulatory decision-making. The purpose of this study is to advance methods for patient and community engagement in patient-centered outcome research (PCOR) and has three objectives. First, demonstrate good practices for patient and community involvement in PCOR projects by applying principles of community-based participatory research (CBPR). Second, address methodological gaps pertaining to the use of stated-preference methods in studying priorities in PCOR. These include identifying the best methods for identifying patient priorities and strategies for analyzing variation in priorities. The investigators also seek to assess the relevance of stated-preference methods to patients and stakeholders using both qualitative and quantitative methods. Third, demonstrate good practices for applying stated-preference methods by studying the priorities of patients with type II diabetes. While type II diabetes provides an important case study, this research will advance approaches and methods that will be broadly generalizable to other diseases, and to diverse patient and stakeholder groups. Clinical Significance: This project will illustrate and advance methods for assessing the values of patients and stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of stated-preference methods in measuring the priorities of patients and stakeholders and directing health care.

Provided treatments

  • Other: Likert Scale
  • Other: Best-Worst Scaling (Case 1)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02637609. The sponsor of the trial is Johns Hopkins Bloomberg School of Public Health and it is looking for 1000 volunteers for the current phase.
Official trial title:
Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes