{"id":286,"date":"2020-04-15T23:43:47","date_gmt":"2020-04-15T23:43:47","guid":{"rendered":"https:\/\/www.socra.org\/blog\/?p=286"},"modified":"2020-08-28T19:27:06","modified_gmt":"2020-08-28T19:27:06","slug":"human-factors-testing-and-clinical-research","status":"publish","type":"post","link":"https:\/\/www.socra.org\/blog\/human-factors-testing-and-clinical-research\/","title":{"rendered":"Human Factors Testing and Clinical Research"},"content":{"rendered":"\n<ul class=\"is-layout-flex wp-block-gallery-1 wp-block-gallery columns-1 is-cropped\"><li class=\"blocks-gallery-item\"><figure><img decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"682\" src=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/04\/ClinicalResearch-1024x682.jpg\" alt=\"\" data-id=\"292\" data-link=\"https:\/\/www.socra.org\/blog\/?attachment_id=292\" class=\"wp-image-292\" srcset=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/04\/ClinicalResearch.jpg 1024w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/04\/ClinicalResearch-300x200.jpg 300w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/04\/ClinicalResearch-768x512.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/li><\/ul>\n\n\n\n<p style=\"text-align:center\">Tim Reeves, CHFP <br>Founder and Managing Director  <br>Human Factors MD <\/p>\n\n\n\n<p><strong><em>Abstract<\/em><\/strong><em>: 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.<\/em><\/p>\n\n\n\n<!--more-->\n\n\n\n<p><strong>Introduction<\/strong><\/p>\n\n\n\n<p>Just as clinical studies are\nnecessary to demonstrate that a drug in a combination product is safe and\neffective therapeutically, human factors studies are necessary to demonstrate\nthat the device in a combination product can also be used safely and\neffectively. Clinical studies and human factors studies are both necessary and\ncomplementary.<\/p>\n\n\n\n<p>Combination products are becoming\nmore and more ubiquitous, primarily because of the need to offset the cost of\nhealthcare and to require patients to take more responsibility for the delivery\nof their healthcare, which includes their medications. While combination\nproducts may seem simple, they often cause problems for users. <\/p>\n\n\n\n<p>The\nU.S. Food and Drug Administration (FDA) has published a long list of known\nissues with combination products in its guidance documents (Table 1). For\nexample, people may not know how to store inhalers, or they may have difficulty\nopening the packages or priming meter-dose inhalers. People may not use the\nbest inhalation technique, or they may not clean the inhalers. <\/p>\n\n\n\n<p>People\nmay have difficulties with injection devices, such as selecting the wrong dose if\nthere are multiple doses, not ensuring that the drug is injectable, and not\nchecking the appearance of the product. They may inject the product at the\nwrong site or not remove the cap. They may not know how to activate the\ninjection device, or they may remove it from the injection site prematurely\nbefore all of the medication has been delivered. <\/p>\n\n\n\n<p>Known\nissues with patches include not entirely removing the adhesive, placing one\npatch on top of another patch, or cutting patches in half to modify the dose. There\nhave been many instances reported to the FDA of children being overdosed\nbecause a disposable patch was not disposed of and the child ingested the\npatch.<\/p>\n\n\n\n<p><strong>Human Factors and Medication Error\nPrevention <\/strong><\/p>\n\n\n\n<p>Human\nfactors is a methodology and a body of knowledge that tries to eliminate or\nreduce the impact of errors related to the use of products such as medical devices. Regulatory agencies\nsuch as the FDA are proponents of human factors studies. Human factors can be\nconsidered a marriage of psychology and engineering. Engineering covers the\ndesign of the product, which in this case is a medical device. Psychology covers\nunderstanding the people who may use the device, including their capabilities,\nlimitations, and predispositions.&nbsp; <\/p>\n\n\n\n<p><strong>Human Factors Studies <\/strong><\/p>\n\n\n\n<p>The FDA and other regulatory\nbodies see human factors testing as a way to mitigate use issues with medical\ndevices and to reduce medication errors. Since the early 2000s, it has become\nincreasingly more difficult to obtain approval of medical devices without human\nfactors testing to demonstrate that people can use a device safely and\neffectively as intended.<\/p>\n\n\n\n<p>The\ntwo types of human factors studies, formative and validation, are similar in\nterms of their approach (see Table 2). After recruiting people who are\nrepresentative of product users, researchers introduce them to the product in a\nway that is similar to the way that they might learn about the product. For a commercial\nproduct where people will be trained when the product is released, users would\nreceive training in the study. If users will learn about a product by reviewing\nthe information that comes with it, then the study will be run that way.<\/p>\n\n\n\n<p>Tests\nare conducted in realistic use environments and evaluate realistic use scenarios.\nParticipants use the device while researchers observe them. Human factors\nstudies are largely about observing users and then questioning them about their\nexperience. Researchers might ask questions about what users were doing, why\nthey did things, and how they interpreted various aspects of the device and its\nuse.&nbsp; <\/p>\n\n\n\n<p>Formative\nstudies are conducted early in the development of a product and are intended to\n<strong><em>inform<\/em><\/strong>\ndevelopment. Results are used iteratively to modify the product and test it\nuntil developers are confident that the device will work appropriately and that\npeople will know how to use it. <\/p>\n\n\n\n<p>While\nthe FDA expects device manufacturers to conduct formative studies, it\nemphasizes validation studies, which are conducted at the end of the\ndevelopment process on the final finished combination product. The device used\nin a validation study must incorporate the final commercial labeling and packaging\ndesigns. Validation studies are post-market simulations of whether people will\nbe able to use the product appropriately after it reaches the market. They are intended\nto demonstrate that the design supports the safe and effective use of the\ndevice when used by actual users in realistic use environments.<\/p>\n\n\n\n<p>Validation\nstudies are almost always simulated-use; noone is administered an actual drug product.\nAs per FDA guidelines, a validation study must include a minimum of 15 people\nper user group. Typically, these studies have between 15 and 120 people. They\nare small studies in comparison to major clinical trials. <\/p>\n\n\n\n<p>All\nof the ways in which people could use the product inappropriately that might\nlead to harm or ineffective therapy must be identified, and the manufacturer\nmust demonstrate that it has reduced the risk of these issues happening as much\nas possible. <\/p>\n\n\n\n<p>Researchers\ncollect two types of data &#8211; objective performance data and subjective\nassessment data. They observe people actually interacting with the device (performance)\nand collect their subjective impressions of what this was like (subjective\nassessment). Subjective assessments are important. People may have difficulties\nwith things that cannot be identified through observation. For example, a\nparticipant may have been tempted to perform some action that would have\nresulted in a safety error; however, the participant changed his or her mind at\nthe last minute. None of these issues may have been evident to an observer. This\nis called a \u201cclose call.\u201d Another user may have gone ahead and made the safety\nerror without self-correcting. <\/p>\n\n\n\n<p>Interviewing\npeople is necessary to uncover these situations. Researchers also collect subjective\nassessment data for things that are difficult to observe in a simulated-use\nstudy. For example, it is difficult in simulated-use studies to test whether\nparticipants know that a product must be refrigerated prior to use. Instead of\ncreating a more elaborate simulation to test whether users understand this\nrequirement, researchers simply ask users where the product should be stored\nprior to use, and researchers assess the participant\u2019s understanding based on\ntheir response. <\/p>\n\n\n\n<p><strong>Human Factors Studies and Clinical\nStudies<\/strong><\/p>\n\n\n\n<p>Human\nfactors studies start as a preliminary analysis during the Pre-investigational New\nDrug application activities. Preliminary analysis involves understanding the\nusers and the use environment as well as doing some initial development of the\ndevice. During Phase 1 and Phase 2 clinical trials, formative testing is\nstarted, followed by validation testing. Before Phase 3, the FDA expects a\nfinished product that has undergone human factors testing that has shown that\nusers have minimal safety-related issues with the use of the device. The timing\nof human factors studies in relation to clinical studies is illustrated in\nFigure 1.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" loading=\"lazy\" width=\"779\" height=\"345\" src=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/04\/HumanFactorSOCRA.png\" alt=\"\" class=\"wp-image-287\" srcset=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/04\/HumanFactorSOCRA.png 779w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/04\/HumanFactorSOCRA-300x133.png 300w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/04\/HumanFactorSOCRA-768x340.png 768w\" sizes=\"(max-width: 779px) 100vw, 779px\" \/><figcaption><strong>Figure 1<\/strong><\/figcaption><\/figure>\n\n\n\n<p>It is\npossible that knowledge gained from the clinical trial will lead to modifications\nof the device, its labeling, or its packaging. In this case, another human\nfactors study may be needed for the New Drug Application submission.&nbsp; <\/p>\n\n\n\n<p>Table\n3 outlines differences between human factors validation tests and major\nclinical studies related to timing, the device, study participants, and sample\nsize. Validation tests are conducted prior to Phase 3 clinical trials. Use of\nthe device is simulated in a human factors study, whereas study participants\nreceive the actual medication in clinical studies. Both validation tests and\nclinical studies use the final commercial product.<\/p>\n\n\n\n<p>The\nparticipants in a clinical trial are patients, whereas the participants in\nhuman factors studies may include everyone who is using the device. Participants\ncould be patients; however, they could also be healthcare professionals such as\npharmacists who will be dispensing the product to patients. If the product has\nmultiple doses, researchers must ensure that the pharmacists can differentiate\nthe doses in order to dispense the right dose. In this situation, the validation\nstudy would involve a mock pharmacy where pharmacists are asked to fill\nprescriptions in different doses.<\/p>\n\n\n\n<p>Validation\nstudies have been done with physicians to ensure that they understand what they\nare prescribing or administering. Participants could also be caregivers who\nwill be administering the drug to the patient. While clinical trials could have\nthousands of participants, human factors studies typically have 45 participants\nto 120, with 15 participants in each user group.<\/p>\n\n\n\n<p>The\nmain difference between human factors studies and major clinical studies is\nthat clinical trials want to minimize variations that could alter the integrity\nof the data that are being collected, whereas human factor studies test the\nvariation among users (Table 4). In clinical trials, the data focus on the\nperformance of the drug, so participants are trained in the appropriate administration\nof the drug. The use environment is tightly controlled and variations in device\nuse are minimized. Human factor studies, on the other hand, study the variation\nin device use among users. Use errors are the dependent measure in a\nhuman factors study, which are used to ensure that when the product is released,\npeople will be able to use it safely and effectively, given variations in\nusers, their experience, their training, and the use environments.<\/p>\n\n\n\n<p>Table\n5 outlines differences between human factors validation tests and major\nclinical studies related to data collection, statistics, and endpoints. Everything\nin the human factors studies focuses on use-related issues, whereas clinical\ntrials seek to control issues in order to prevent interference with data\ncollection. Data collection in human factors studies focuses on performance of critical\ntasks: successes, failures, operational difficulties, and close calls. In\nclinical trials, data collection focuses on the performance of the drug. Human\nfactors studies focus on how people interact with the device and whether they understand\nit well enough to use it safely.<\/p>\n\n\n\n<p>Unlike\nclinical trials, there are no statistics in human factors studies, which\nprovide descriptive information and counts of the number of people who made\neach type of use error. The endpoints are quite different. Human factors\nstudies are qualitative and have no acceptance criteria; instead, these studies\nfocus on how people perform when using a device, and they focus on the root\ncause of any issues that arise during use. In clinical trials, the endpoint is evaluation\nof whether the drug is safe and effective.<\/p>\n\n\n\n<p><strong>Conclusion<\/strong><\/p>\n\n\n\n<p>Clinical studies and human factors studies are complimentary. Regulators require both types of studies. The best drug will not be beneficial if users cannot use it appropriately. <strong><br><br><\/strong><\/p>\n\n\n\n<p><strong>TABLE 1<\/strong><\/p>\n\n\n\n<p><strong>Known Issues with Combination\nProducts* <\/strong><\/p>\n\n\n\n<ul><li>Known use issues with inhalers: <ul><li>Improper storage prior to use<\/li><li>Unable to open package<\/li><li>Unable to assemble or assembled incorrectly<\/li><li>Not priming at all or priming incorrectly<\/li><li>Improper inhalation technique<\/li><li>Improper seal of mouth on mouthpiece<\/li><li>Not waiting long enough between doses<\/li><li>Failing to clean or maintain<\/li><li>Storing under wrong conditions<\/li><li>Failing to properly dispose of device<\/li><\/ul><\/li><li>Known use issues with injection devices:<ul><li>Selecting incorrect product<\/li><li>Failure to check the drug appearance or drug expiration<\/li><li>Not priming at all or priming incorrectly<\/li><li>Identifying incorrect injection site<\/li><li>Not removing injector cap<\/li><li>Holding injector upside down<\/li><li>Unable to activate the injector<\/li><li>Premature removal (wet injection)<\/li><li>Unable to determine if dose is given<\/li><\/ul><\/li><li>Known use issues with patches:<ul><li>Not removing all or some of the protective layer<\/li><li>Taping patches on rather than using patch adhesive<\/li><li>Placing new patches on top of old patches<\/li><li>Applying multiple patches at once<\/li><li>Failing to remove previous patch<\/li><li>Misunderstanding dosing including replacement schedule<\/li><li>Cutting patches to \u201cadjust\u201d dosing<\/li><li>Failing to safely discard used patches<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>Source: <em>FDA Draft Guidance &#8211; Human Factors Studies and Related Clinical\nConsiderations in Combination Product Design and Development<\/em>, February 2016<strong><br>\n<\/strong><\/p>\n\n\n\n<p><strong>TABLE 2<\/strong><\/p>\n\n\n\n<p><strong>Types of Human Factors\nStudies <\/strong><\/p>\n\n\n\n<ul><li>Formative:<ul><li>Prototype(s) of combination product<\/li><li>Iterative in nature: inform design changes<\/li><li>Inform the content of the human factors validation study<\/li><li>Generally completed early in Investigational New Drug application development<\/li><\/ul><\/li><li>Validation:<ul><li>Final finished combination product<\/li><li>Demonstrate that design supports safe and effective use with       representative users in expected use environment(s)<\/li><li>Ideally, human factors validation testing should precede any       major clinical study (Phase 3)<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong><br>\n<\/strong><\/p>\n\n\n\n<p><strong>TABLE 3<\/strong><\/p>\n\n\n\n<p><strong>Human Factors Validation Tests Versus Major Clinical Studies: Part 1<\/strong><\/p>\n\n\n\n<ul><li>Timing:\n<ul><li>Human\nfactors validation test: <ul><li>Before major clinical\nstudies (before Phase 3)<\/li><\/ul><\/li><\/ul><ul><li>Major\nclinical study: <ul><li>Follows human factors\nwork (including validation study)<\/li><\/ul><\/li><\/ul><\/li><li>Device:<ul><li>Human\nfactors validation test: <ul><li>Prototypes (formative)\nor final commercial product (validation)<\/li><\/ul><\/li><\/ul><ul><li>Major\nclinical study: <ul><li>Final commercial product<\/li><\/ul><\/li><\/ul><\/li><li>Study\nparticipants:<ul><li>Human\nfactors validation test: <ul><li>Representative users\n(patients, caregivers, healthcare professionals, and adults or children)<\/li><\/ul><ul><li>Healthcare professionals\ncould include those prescribing, dispensing, and administering<\/li><\/ul><\/li><\/ul><ul><li>Major\nclinical study: <ul><li>Patients<\/li><\/ul><\/li><\/ul><\/li><li>Sample\nsize:<ul><li>Human\nfactors validation test: <ul><li>15 in each user group,\nabout 45 total<\/li><\/ul><\/li><\/ul><ul><li>Major\nclinical study: <ul><li>Thousands<\/li><\/ul><\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>TABLE 4<\/strong><\/p>\n\n\n\n<p><strong>Human Factors Validation Tests Versus Major Clinical Studies: Part 2<\/strong><\/p>\n\n\n\n<ul><li>Training:<ul><li>Human factors study: <ul><li>Should mimic commercial practice<\/li><li>If training is a risk mitigation, participants should be trained<\/li><li>If not, or if training is not reliable, participants should be        untrained<\/li><\/ul><\/li><li>Major clinical study: <ul><li>Patients trained on proper use of device<\/li><li>Minimize variations in how device is used on clinical data<\/li><\/ul><\/li><\/ul><\/li><li>Use environment:<ul><li>Human factors study: <ul><li>Should mimic actual use environments incorporating situations factors that may adversely affect use&nbsp;        <\/li><\/ul><\/li><li>Major clinical study: <ul><li>May be controlled<\/li><li>Minimize variations in how device is used on clinical data<\/li><\/ul><\/li><\/ul><\/li><li>Use scenarios:<ul><li>Human factors study: <ul><li>Common and low frequency (but safety-related) use scenarios<\/li><\/ul><\/li><li>Major clinical study: <ul><li>Common<\/li><li>Controlled<\/li><li>Minimize variations in how device is used on clinical data<\/li><\/ul><\/li><\/ul><\/li><li>Use:<ul><li>Human factors study: <ul><li>Simulated<\/li><\/ul><\/li><li>Major clinical study: <ul><li>Actual<\/li><\/ul><\/li><\/ul><\/li><li>Use errors: <ul><li>Human factors study: <ul><li>Dependent measure<\/li><li>Monitor for evidence of failures, operational difficulties, and close calls<\/li><\/ul><\/li><li>Major clinical study:<ul><li>Independent variable<\/li><li>Controlled<\/li><li>Want to minimize use errors to ensure data integrity<\/li><\/ul><\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong><br>\n<\/strong><\/p>\n\n\n\n<p><strong>TABLE 5<\/strong><\/p>\n\n\n\n<p><strong>Human Factors Validation Tests\nVersus Major Clinical Studies: Part 3<\/strong><\/p>\n\n\n\n<ul><li>Data collection:<ul><li>Human factors study: <ul><li>Performance on critical tasks: Successes, failures, operational\n       difficulties, and close calls <\/li><li>Subjective assessments of task difficulty<\/li><\/ul><\/li><li>Major clinical study:<ul><li>Drug effectiveness<\/li><\/ul><\/li><\/ul><\/li><li>Statistics:<ul><li>Human factors study: <ul><li>Descriptive only<\/li><li>Typically, just sums<\/li><\/ul><\/li><li>Major clinical study:<ul><li>Inferential<\/li><li>Mean estimation and confidence limits<\/li><\/ul><\/li><\/ul><\/li><li>Endpoints:<ul><li>Human factors study: <ul><li>Residual risks have been mitigated as much as possible<\/li><li>Product benefits outweigh risks<\/li><\/ul><\/li><li>Major clinical study:<ul><li>Drug is efficacious and safe<\/li><\/ul><\/li><\/ul><\/li><\/ul>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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 &hellip; <\/p>\n<p><a href=\"https:\/\/www.socra.org\/blog\/human-factors-testing-and-clinical-research\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Human Factors Testing and Clinical Research<\/span> &rarr;<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"categories":[78,55],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.6.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Human Factors Testing and Clinical Research - SOCRA Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.socra.org\/blog\/human-factors-testing-and-clinical-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Human Factors Testing and Clinical Research - SOCRA Blog\" \/>\n<meta property=\"og:description\" content=\"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. 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