Sponsored Webcast: Human Factors Inputs to Clinical Trials: A Commonly Missed Opportunity

This webcast will demonstrate the unique benefits of applying human factors methods and solutions to clinical and IDE trials. You will learn specific human factors techniques for risk analyses, training, instructions, interaction videos, and checklists.

Most pharmaceutical and medical technology sponsors do not focus on labeling, training, or instructions for use until the commercial phase of product development. However, these critical elements can significantly affect the success of a clinical trial. Clinical research and human factors are often treated as separate disciplines. Even the most promising product cannot demonstrate safety or effectiveness if it is not used correctly during an IDE study or clinical trial.

This webcast explores how human factors science, methods, and tools can strengthen clinical trials by reducing use errors among research staff and study participants. By addressing human factors early, organizations can improve data quality and minimize confounding factors that may affect study outcomes. Examples include use-related risk analyses, staff and participant training programs, instructions for use, interaction videos, checklists, and other human factors solutions designed to support successful clinical research.

Learning Objectives

Upon completion of this webcast, attendees will understand:

  •  The triad of risks associated with clinical trials that can adversely affect evaluations of efficacy and why these risks have increased with at-home clinical studies becoming the norm.
  • How human factors can be used to reduce use errors in clinical trials, whether committed by clinical trial staff or study participants outside of the clinical setting.
  • The specific techniques that apply human factors science to clinical trial user interfaces towards reducing use errors and eliminating confounds to efficacy data.

Who Should Attend:

  • Regulatory professionals
  • Clinical trial managers, associates, etc.
  •  Product managers
  • Quality professionals

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].

Speakers

Anthony  Andre

Anthony Andre

Director, Interface Analysis Associates, LLC

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Margot  Helm

Margot Helm

Human Factors Engineer, Interface Analysis Associates

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