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The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

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Published on: February 19, 2021

Reflections on the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) Process-Findings from a

Timothy C Guetterman¹, Michael D Fetters¹, Laurie J Legocki¹

¹Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.

Clinical Research and Regulatory Affairs

|December 2, 2015

Summary

This summary is machine-generated.

Stakeholders found adaptive clinical trial designs valuable but require more education. Enhanced understanding and articulation of adaptive methodologies are crucial for future trial planning.

Keywords:

adaptive clinical trials emergency medicine neurological emergencies qualitative research

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Area of Science:

Clinical Trials Methodology
Adaptive Trial Design
Translational Research

Background:

The Adaptive Designs Advancing Promising Treatments Into Trials (ADAPT-IT) project focused on integrating flexible adaptive designs into pivotal clinical trials.
There is a lack of guidance for academic institutions in planning adaptive trials.
This study assessed the trial development process within the ADAPT-IT project.

Purpose of the Study:

To explore stakeholder perspectives on the ADAPT-IT adaptive design development process.
To understand lessons learned regarding adaptive trial design and development.
To gather insights from key stakeholders involved in adaptive trial implementation.

Main Methods:

Qualitative study utilizing semi-structured interviews with ten key stakeholders.
Incorporated observations of the adaptive trial development process.
Employed qualitative thematic text data analysis for theme identification.

Main Results:

Four key themes emerged: participant education, process evolution through feedback, procedures for enhancing future trials, and broader community education.
Participants showed increased consideration of flexible adaptive designs.
The process highlighted the iterative nature of adaptive trial development.

Conclusions:

Additional education is necessary for understanding and articulating adaptive trial methodologies.
Stakeholders recognized the benefits of adaptive designs but need further training.
Improved educational resources are needed for the research community to facilitate adaptive trial planning.