Category: Investigational Drugs and Devices (IDE/IND)

Human Factors Testing and Clinical Research

Tim Reeves, CHFP
Founder and Managing Director
Human Factors MD

Abstract: Human factors simulated-use studies provide a valuable tool for evaluating the usability and safety of medical devices, including combination products such as inhalers, injection devices, and transdermal patches. Through human factors studies, researchers evaluate how users and devices perform in low-frequency high-risk situations that may not occur in controlled clinical trials. This article provides an overview of the role of human factors testing in combination product development as well as how human factors studies complement traditional clinical trials in establishing safety and efficiency in drugs and devices.

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Reducing Over-reporting to INDs and Increasing Efficiencies at Clinical Research Sites

Sarah Attwood, BSc
Director of Client Services
IntegReview IRB

Abstract: Institutional review boards (IRBs) continue to be overburdened with reports not required by federal regulations. It is important to understand the difference between what the regulations require and what has become an industry standard. Additionally, clinical research sites are often confused about reporting requirements and err on the side of conservatism by over-reporting. By clearly identifying regulatory requirements, the clinical research industry may become more efficient and eliminate unnecessary work for sites as well as IRBs.

Clinical researcher at computer

Introduction

Study sites are over-reporting adverse events (AEs) and serious adverse events (SAEs) for studies conducted under Investigational New Drug (IND) applications. IRBs are required by the U.S. Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) within the Department of Health and Human Services to review “unanticipated problems involving risks to participants or others.”  

IntegReview IRB is a central IRB that reviews many protocols each year, just as institutional IRBs do. In 2016, IntegReview IRB saw an increase in the number of IND safety reports and a slight decrease in SAE reports. The reason for these changes is unknown. IntegReview IRB is seeing about a four-fold increase in IND safety reports, which is far above the increase in business.

IRBs receive many IND safety reports that are not related to the current protocol at the clinical researchsite. The reports could be about something that is happening in Asia or Europe, a different use of the drug, or a different research project. These reports must be processed, even though they are not under the jurisdiction of the IRB for the current study, creating information overload.

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