Kelly Dumais, Ph.D.<\/strong> – Director, eCOA Science and Consulting at Clario
Sarah Gary, Ph.D.<\/strong> – Senior Scientific Advisor eCOA Clinical Science and Consulting at Clario<\/p>\n\n\n\n
Accessibility, both to and within clinical trials is a crucial issue that demands ongoing attention. Hence it is the subject of multiple reports from the FDA. For example, draft guidance (launched in November 20201<\/sup><\/span>) recommends changing trial design and eligibility criteria in response to clinical trials potentially not being representative of the population as a whole or of the population for whom the drug is intended once approved.<\/p>\n\n\n\n The FDA also released guidance last June2<\/sup><\/span> recommending that, \u201cCOA [be] accessible for patients with impairments…\u201d and to conduct usability testing on accessibility features. This ensures that those taking part in the trial can use the device and complete the assessment, regardless of impairment or disability. <\/p>\n\n\n\n Improving accessibility features of digital health technologies (DHT) is important to increase diversity of the clinical trial population, inclusion of more people, as well as ensuring compliance with ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) standards. This includes features designed to assist participants with a vision impairment, for example, a zoom functionality, which enables users to enlarge images or text by simply pinching the screen with their fingers.<\/p>\n\n\n\n …this functionality has not been scientifically validated to ensure equivalence…<\/p><\/blockquote><\/figure>\n\n\n\n Although this functionality has not been scientifically validated to ensure equivalence, pharmaceutical companies are keen to include this in their studies already. Without validation however, eCOA providers are reticent to take this on. Even if the zoom capability is key to the study and the decision has been made to include it, the implementation must be considered very carefully. For example, how does the zoom function work? Is all information visible to the participant? Are they guaranteed to see all relevant information before moving to the next step? Without taking in to account these types of questions (and more), there are potential risks to data integrity.<\/p>\n\n\n\n Any COA data captured using unvalidated zoom functionality carries a potential risk of causing data variability and noise. There may be a possibility that participants could enter a different response depending on whether the zoom in functionality is on or off. The risk is higher when used as a primary endpoint in a Phase III study than if the endpoint is exploratory and within an assessment not directly linked to marketing claims. <\/p>\n\n\n\n …the next logical step would be to do the research and usability testing to investigate whether zoom functionality (i.e., larger text) actually impacts COA responses.<\/p><\/blockquote><\/figure>\n\n\n\n To put both pharma and eCOA providers at ease, the next logical step would be to do the research and usability testing to investigate whether zoom functionality (i.e., larger text) actually impacts COA responses. If the research finds there is no negative impact, i.e., equivalence is proven, it potentially could assist any studies that already incorporated a zoom function to escape a potential reduction in data quality\/integrity, as long as the implementation is done right.<\/p>\n\n\n\n Patient-centricity is critical in clinical trials and technology helps to achieve this. To provide a better experience for trial participants with impairments or disability, our industry should put its commitment to scientific rigor front and center, commit to doing the relevant research and put that technology to use.<\/p>\n\n\n In an era where digital health technologies are transforming care, ensuring accessibility is paramount. In MedCity News, Kelly Dumais offers comprehensive insight into how integrating accessibility features not only fosters inclusion but elevates the patient experience as a whole.<\/p>\n\n\n\n Bryan McDowell, M.Sc., M.B.A.<\/strong><\/strong><\/strong><\/p>\n\n\n\n VP, eCOA Science and Consulting<\/p>\n\n\t<\/div>\n\n\n\n Kelly Dumais, Ph.D.<\/strong><\/strong><\/strong><\/p>\n\n\n\n Director, eCOA Science and Consulting<\/p>\n\n\t\t<\/div>\n\t<\/div>\n\n\n\n Sarah Gary, Ph.D.<\/strong><\/strong><\/strong><\/p>\n\n\n\n Senior Scientific Advisor eCOA Clinical Science and Consulting<\/p>\n\n\t<\/div>\n\n<\/div>\n<\/div><\/div>\n\n\n\n 1<\/sup>https:\/\/www.fda.gov\/media\/127712\/download<\/a><\/p>\n\n\n\nLinking device functionality with trial accessibility and diversity<\/h2>\n\n\n\n
Taking the risk out of \u201czoomed\u201d data capture<\/h2>\n\n\n\n
Championing inclusive digital health<\/h3>\n\n\n\n
Written by<\/h4>\n\n\t<\/div>\n\n<\/div>\n\n\n
![\"Bryan](\"https:\/\/clario.com\/wp-content\/uploads\/2022\/08\/Bryan-McDowell-SQ.jpg\")
<\/figure>\n\n\n\n![\"Kelly](\"https:\/\/clario.com\/wp-content\/uploads\/2022\/07\/Kelly-Dumais-headshot.png\")
<\/figure>\n\n\n\n![\"Sarah](\"https:\/\/clario.com\/wp-content\/uploads\/2023\/04\/Sarah-Tressel-Gary-headshot.png\")
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