A clinical trial population should mimic the patient population that will ultimately use the therapy that is being studied. Sounds logical, doesn’t it? Unfortunately, this has not always been the case and there have been negative consequences, such as instances where people with disabilities or of certain racial groups experienced adverse effects to approved drugs that were not tested on “people like them.”
A patient-centric approach
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Just one of the many challenges of ensuring that the clinical trial population accurately reflects the patient population, so is the challenge of the Digital Health Technologies (DHTs), such as electronic patient reported outcomes (ePRO), which are becoming increasingly pervasive in clinical trials, which do not always include the appropriate accessibility features. These accessibility features make participation feasible for patients with impairments, disabilities or other disadvantages that are either unrelated to or common with the disease state that is being targeted. One of the ways the clinical trial technology provider community can support a patient-centric approach to conducting clinical trials is to provide DHTs with more features that accommodate certain needs, for example, bigger font for those with visual impairments. This will increase inclusivity, provide participant accommodations that increase data integrity and ultimately, yield more accurate study results for safer and more efficacious therapies.
Technology for all
Decades ago, some technology companies, especially the larger ones that serve the general population and/or businesses, started incorporating accessibility features to support social inclusion by making the technology usable by as many people as possible. Accessibility features are particularly useful to individuals with impairments or disabilities, or those who may be older or unfamiliar or uncomfortable with technology. Common accessibility features include enlarged buttons or cursors, closed-captioning, high-contrast color themes, text-to-speech, speech recognition and keyboard shortcuts.
Today, clinical trial technology providers are following suit for several reasons:
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- The industry-wide call to action to address the lack of diversity, equity and inclusion within clinical trials
- The increased reliance on technology to optimize the efficiency of clinical trials and improve data integrity/quality
- The increased use of remote technologies, accelerated by the Covid-19 pandemic, which shifts some of the data collection burden onto participants who may or may not be tech-savvy
- Detailed guidance from the FDA (December 2021 and June 2022) on adding accessibility features to DHTs, such as eCOAs, to accommodate inclusive patient populations
Next steps for clinical trial technology providers
Clinical trial technology providers are continuously evolving their offerings. At this pivotal moment, we need to ask ourselves what can we do to optimize patient usability of ePRO devices in order to make them more accessible to a larger pool of participants. This, in turn, will increase diversity, equity and inclusion in clinical trials. Here are some suggestions:
- Start by understanding the needs and limitations of the patients affected by the targeted disease – whether they are typical of the demographic who tend to get the disease (e.g., sight-impairment in older patients), or are caused by the disease or side effects of treatment (e.g., tremors in patients with Parkinson’s Disease)
- Base DHT development plans on the identified patient needs
- Use the same functionality that patients use in their everyday lives (e.g., pinching to zoom-in to make text larger and easier to read) to provide a more user-friendly experience, increase usability, and decrease the chance of error
- Conduct comparability research to ensure that measurement properties of the assessment are not altered by the accessibility feature and that data integrity is maintained
The intersection of scientific rigor and patient behavior
Drug development is a complex, multi-faceted process. Those of us who have chosen this career path have a responsibility to uphold scientific rigor while also focusing on the daily lives of individual patients and their loved ones. It’s through technology that these two elements intersect. The addition of accessibility features to DHTs such as eCOA will result in a better experience for study volunteers, a more accurate participant pool and the right therapy going to all those who deserve it.
Dr. Kelly Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently a Principal Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.
