Embracing accessibility: The future of clinical trials

Harnessing accessibility functionalities to broaden patient participation and ensure data integrity

Bryan McDowell, M.Sc., M.B.A. – VP, eCOA Science and Consulting at Clario

Taking part in clinical trials should be as smooth as possible for a patient, and with the growing use of technologies in clinical studies the usability and functionality of those technologies are critical aspects to consider to provide a better patient experience. It is well-known that a better patient experience and ability to use the technology leads to increased data quality, retention, compliance and adherence. For people who have impairments (e.g., vision) the ability to use technology to capture study outcomes and therefore access to participate in clinical trials may become more challenging in the absence of the appropriate functionalities e.g., larger text, zoom in/zoom out.

Accessibility in a digital age: eCOA’s role

In 2022, the FDA urged the industry to enhance the accessibility of clinical trials to people with impairments and to perform usability tests on new accessibility features. The call for more accessible trials seems both simple and necessary. However, clinical trials demand high-quality, unambiguous data to allow regulators to accurately assess the potential benefits and risks of a new medical product. Understandably, study sponsors may be hesitant to introduce elements that could disrupt this process or impact data integrity.This reluctance is reminiscent of the transition from paper to digital data collection using Electronic Clinical Outcome Assessments (eCOAs). While the digital approach was faster¹, more accurate^2,3, cost-effective⁴, and more efficient⁵ than traditional methods, it posed its own challenges. Developers needed to demonstrate the equivalence of eCOA to paper, leading to extensive validation studies. Similar efforts are now needed to establish trust in the relevant electronic accessibility features, a step that can be costly and few have taken.

The imperative of data quality 

To advance the use of accessibility functionalities, we must compare eCOA device data capture with and without accessibility features activated. 

Clario’s groundbreaking study, designed to evaluate the equivalence of zoom-in/zoom-out functionality, demonstrates the importance of robust scientific analysis to ensure accessibility features and data integrity go hand-in-hand. Imagine a zoom-in feature that only displays the first three of five response options. If a patient is unaware of the need to scroll down to view the rest before responding, the data integrity could be compromised. Thoughtful design, rigorous research, and patient feedback are essential to prevent these problems and implement accessibility features successfully. 

Accessible eCOAs may lead to faster recruitment, a more diverse population, and richer and more accurate data sets in clinical trials. This functionality ensures that devices used in trials are fit for purpose and increase inclusivity, without sacrificing data integrity. 

Answering the call: A model for the future

Drawing from its expertise in clinical trial management, Clario’s study offers a template for others to follow. 

This randomized, non-interventional crossover study will involve 55 individuals with a chronic health condition or an injury causing daily discomfort. By investigating comparability between eDiaries with and without zoom functions, the study will collect Patient Reported Outcomes (PROs) using commonly used question formats.

The study is expected to be completed with initial results presented in October 2023 at the Summit for Clinical Ops Executives (SCOPE) meeting in Barcelona. 

The industry must keep pace 

Accessibility is vital for the biopharmaceutical and clinical research industry’s success. It broadens the pool of eligible participants, addresses disparities in medical research, and is more than a regulatory concern – it’s an industry-wide imperative. Recognizing accessibility’s importance to patients, sponsors, and the industry at large is crucial. We cannot afford to lag behind in a world where inclusion and diversity in medical research are paramount.

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