A clinical study population should mimic the patient population that will ultimately use the therapy being studied. Sounds logical right? Unfortunately, this has not always been the case and there have been negative consequences, such as cases where people with disabilities or certain racial groups have experienced side effects from approved drugs that have not been tested on ‘people like them’.
A patient-centric approach
Just one of the many challenges to ensuring that the clinical trial population accurately reflects the patient population is that of digital health technologies (DHTs), such as , which do not always include the appropriate accessibility features. These accessibility features make participation possible for patients with impairments, disabilities, or other disadvantages that are either unrelated to, or common to, the targeted disease state. One of the ways the clinical trial technology provider community can support a patient-centric approach to conducting clinical trials is by adding more features to DHTs that address specific needs, such as: B. Larger font for people with visual impairments. This will increase inclusivity, provide shelters for participants, increase data integrity, and ultimately provide more accurate study results for safer and more effective therapies.
technology for everyone
Decades ago, some technology companies, especially the larger ones serving the general population and/or businesses, started building in accessibility features to support social inclusion by making the technology usable for as many people as possible. Accessibility features are particularly useful for people with impairments or disabilities, or for people who may be older, unfamiliar with technology, or unwell. General accessibility features include enlarged buttons or cursors, subtitles, high-contrast color themes, text-to-speech, speech recognition, and keyboard shortcuts.
Today, clinical trial technology providers are following suit for several reasons:
- The industry-wide call to action to address the lack of diversity, equity and inclusion in clinical trials
- The increasing reliance on technology to optimize clinical trial efficiency and improve data integrity/quality
- The increased use of remote technologies, accelerated by the Covid-19 pandemic, is shifting some of the data collection burden to attendees 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 B. eCOAs to account for integrative patient populations
Next steps for clinical trial technology providers
Clinical trial technology providers are constantly evolving their offerings. At this crucial moment, we must ask ourselves what we can do to optimize the patient usability of ePRO devices to make them more accessible to a larger audience. This in turn will increase diversity, equity and inclusion in clinical trials. Here are a few suggestions:
- Begin by understanding the needs and limitations of the patients affected by the target disease—whether they are typical of the demographic prone to get the disease (e.g., visual impairment in elderly patients), or driven by the Disease or side effects caused by treatment (eg, tremors in patients with Parkinson’s disease)
- Base DHT development plans on identified patient needs
- Use the same features that patients use in their daily lives (e.g., pinch to make text larger and easier to read) to provide a more user-friendly experience, increase usability, and reduce the likelihood of errors
- Conduct comparative studies to ensure that the 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 process with many facets. Those of us who have chosen this career path have a responsibility to maintain scientific rigor while maintaining a focus on the daily lives of individual patients and their loved ones. Technology overlaps these two elements. Adding accessibility features to DHTs like eCOA will result in a better experience for study participants, a more accurate participant pool, and the right therapy for everyone who deserves it.