Presentation
A CUHF Case Study with FDA: Learnings for Industry
DescriptionCore Human Factors, Inc. conducted a comparative use human factors (CUHF) study commissioned by the U.S. Food and Drug Administration (FDA) to provide additional reference information to industry and to explore the application and challenges of the current Draft Guidance on ANDA CUHF Studies. The primary objective of this research was to collect data intended to inform FDA’s pre-ANDA and ANDA internal review processes and the advice FDA provides the generic drug industry.
The CUHF study compared a semi-automated pen injector to a manual pen injector, focusing on three “other design differences”: 1) Extended dose selector vs. no extension, 2) Visibility of other doses/markings on the extended selector, and 3) Manual (dynamic) push vs. automated (static) injection mechanisms. The primary objective of this study was to compare use success rates for these two types of pen injector given these “other design differences” using a noninferiority design.
This presentation will discuss the known challenges of conducting CUHF studies according to the Guidance and how they were addressed in this study, including:
• Statistical Analysis Plan (SAP): determining error rates and corresponding sample sizes
• Study participant recruitment and use of surrogates
• Selection of tasks for evaluation
• Treatment of study artifacts
Secondary objectives included exploring differences in use success rates for other dose delivery tasks and conducting qualitative root cause analyses of use events.
Statistical analysis of the study results demonstrated that the Test Product (manual pen) may be substitutable for the RLD (semi-automated pen) among experienced adult users, with no statistically significant increase in use error rates for critical tasks impacted by differences in external critical design attributes.
This project was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) through a contract 75F40123D00028/75F40123F19001. The presentation contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
The CUHF study compared a semi-automated pen injector to a manual pen injector, focusing on three “other design differences”: 1) Extended dose selector vs. no extension, 2) Visibility of other doses/markings on the extended selector, and 3) Manual (dynamic) push vs. automated (static) injection mechanisms. The primary objective of this study was to compare use success rates for these two types of pen injector given these “other design differences” using a noninferiority design.
This presentation will discuss the known challenges of conducting CUHF studies according to the Guidance and how they were addressed in this study, including:
• Statistical Analysis Plan (SAP): determining error rates and corresponding sample sizes
• Study participant recruitment and use of surrogates
• Selection of tasks for evaluation
• Treatment of study artifacts
Secondary objectives included exploring differences in use success rates for other dose delivery tasks and conducting qualitative root cause analyses of use events.
Statistical analysis of the study results demonstrated that the Test Product (manual pen) may be substitutable for the RLD (semi-automated pen) among experienced adult users, with no statistically significant increase in use error rates for critical tasks impacted by differences in external critical design attributes.
This project was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) through a contract 75F40123D00028/75F40123F19001. The presentation contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
Event Type
Oral Presentations
TimeMonday, March 232:37pm - 3:00pm EDT
LocationGramercy
Medical and Drug Delivery Devices