The clinical trial population should mimic the population of patients who 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 from certain racial groups have had adverse effects from approved drugs that have not been tested on ‘people like them’.
A patient-centered approach
Just one of the many challenges to ensuring that the clinical trial population accurately reflects the patient population is the challenge of digital health technologies (DHTs), such as electronic patient reported outcomes (ePRO), which are becoming increasingly common in clinical trials. , which do not always include the appropriate accessibility features. These accessibility features make participation feasible for patients with disabilities, impairments, or other impairments that are either unrelated to or common to the disease state being targeted. One way the clinical trial technology vendor community can support a patient-centered approach to conducting clinical trials is to provide DHT with more features that address specific needs, such as larger font for people with visual impairments. disabilities. This will increase inclusion, ensure participant accommodation, which increases data integrity, and ultimately lead to more accurate study results for safer and more effective therapies.
Technology for everyone
Decades ago, some technology companies, especially larger ones that serve the general population and/or businesses, began to include accessibility features to support social inclusion by making technology usable by as many people as possible. Accessibility features are especially useful for people with disabilities or disabilities, or those who may be older or unfamiliar or uncomfortable with technology. Common accessibility features include enlarged buttons or cursors, closed captions, 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
- Increased 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, which shifts some of the data collection burden to actors who may or may not be tech savvy
- Detailed guidance from FDA (December 2021 and June 2022) to add accessibility features to DHTs, such as eCOA, to accommodate inclusive patient populations
Next steps for clinical trial technology providers
Clinical trial technology providers are constantly evolving their offerings. At this pivotal moment, we must ask ourselves what we can do to optimize patient usability of ePRO devices to make them more accessible to a wider range of participants. This, in turn, will increase diversity, equity and inclusion in clinical trials. Here are some suggestions:
- Begin by understanding the needs and limitations of patients affected by the target disease—whether they are typical of the demographic group prone to the disease (eg, vision impairment in older patients), or caused by the disease or the side effects of treatment (eg tremors in patients with Parkinson’s disease)
- Base DHT development plans on identified patient needs
- Use the same functionality that patients use in their daily lives (eg pinch to zoom to make text larger and easier to read) to provide a more comfortable experience, increase usability and reduce the likelihood of mistake
- Perform a comparability study to ensure that the measurement properties of the score 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, multifaceted process. Those of us who have chosen this career path have a responsibility to maintain scientific rigor while focusing on the everyday lives of individual patients and their loved ones. Through technology, these two elements intersect. Adding accessibility features to DHT, such as eCOA, will result in a better experience for study volunteers, more accurate recruitment of participants, and the right therapy for all those who deserve it.