Barriers and Improvements Affecting Inclusion and Accessibility in Clinical Trials

The Importance of Accessibility in Clinical Trials?

Accessibility in clinical trials is not just an ethical imperative – it’s a scientific one. Ensuring that people with disabilities have the opportunity to participate in clinical trials leads to more representative research outcomes. When trials lack diversity, they risk producing findings that may not fully apply to all populations.?

For example, nearly three-quarters of clinical trials have eligibility criteria that tend to exclude adults with intellectual disabilities, either directly or indirectly [1]. Such exclusion not only reduces the validity of trial results but also perpetuates healthcare disparities.?

In this blog post, we will explore the importance of accessibility in clinical trials and provide insights into strategies for improvement and existing resources that enhance inclusivity.?

Key benefits of providing accessibility in clinical trials include:?

• Broader participant pools, that reflect the diversity of real-world populations.?
• Identifies health disparities and informs targeted treatment strategies.?

• Benefits individual participants by aligning with their health-specific needs.?

• Strengthens overall systemic health outcomes and medical research capabilities.?

By addressing barriers to inclusion, clinical trials can better serve diverse communities, improving both individual patient care and the healthcare system as a whole.?

Barriers to Accessibility in Clinical Trials?

Despite progress, several barriers persist that prevent full inclusion of individuals with disabilities in clinical trials:?

1. Logistical Challenges?

Physical access to trial sites can be a significant obstacle for individuals with mobility impairments. For instance, a lack of wheelchair-accessible entrances or elevators at trial locations can deter participation. According to a study published on PMC, after reviewing a total of 360 studies, it was found that only 21 met the inclusion criteria, which required healthcare providers to be a significant component in the clinical trial enrollment process.?

Example: A participant with a physical disability may be unable to attend weekly visits if public transportation is not accessible or if the trial site is in a remote area.?

2. Technological Barriers?

As decentralized trials become more common, technology plays a critical role. However, many trial-related apps and platforms are not designed with accessibility in mind. For example, the quality of mobile health apps encountered by physicians and patients varies significantly. A study published in Nature? revealed that popular oncology apps, in particular, often failed to meet high-quality standards across various domains and did not fully align with end-user requirements??

Example: Visually impaired participants may struggle to navigate online consent forms or trial monitoring platforms if screen readers are not supported.?

3. Communication Hurdles?

Clinical trial materials, such as informed consent documents, are often not available in accessible formats like braille, large print, or audio. Similarly, participants who use sign language may face challenges communicating with trial staff.?

Data Point: Although 93% of respondents reported that they sometimes or often inform providers about their hearing loss, 29.3% still stated that no accommodations were made to enhance communication according to report. ?

4. Design of Trials?

Many clinical trials exclude individuals with disabilities through overly restrictive eligibility criteria. For instance, trials may exclude participants with coexisting conditions, which disproportionately affects people with disabilities.?

Example: Eligibility criteria impacting individuals with disabilities included exclusions based on psychiatric conditions (68%), substance use (62%), HIV or hepatitis (53%), cognitive or intellectual disabilities (42%), visual impairments (34%), hearing impairments (10%), mobility challenges (9%), long-term care needs (6%), and speech or communication disabilities (3%), according the research article. ?

5. Cultural and Attitudinal Factors?

Implicit biases and lack of awareness among trial organizers can also limit accessibility. Assumptions about the capabilities of people with disabilities may lead to unintentional exclusion.?

Recent Improvements and Innovations

While challenges remain, the clinical research community has made notable strides toward improving accessibility:?

1. Adaptive Trial Design?

Inclusive trial designs that accommodate diverse participants are gaining traction. Adaptive trials use flexible protocols to modify enrollment criteria or treatment plans based on participants’ needs.?

2. Technology Advancements?

Remote monitoring and wearable devices have made it easier for participants to engage in trials from home. Decentralized clinical trials (DCTs) enabled by telemedicine have significantly increased participation among individuals with limited mobility or geographical constraints.?

3. Policy Changes?

Regulatory agencies are emphasizing the importance of inclusion. Various regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established guidelines to promote accessibility within clinical trials.?

These guidelines strive to ensure inclusivity for individuals with disabilities, older adults, and minority groups. Recommendations typically include:?

1. Providing trial information in accessible formats, such as plain language documents or videos with captions.?

2. Ensuring that trial locations are physically accessible and compliant with accessibility standards.?

3. Simplifying the consent process using understandable language and assistive technologies.?

The FDA’s Diversity Plan encourages sponsors to outline specific measures for recruiting underrepresented groups, including individuals with disabilities. Similarly, the EMA has integrated inclusivity recommendations into its Good Clinical Practice (GCP) standards.?

4. Collaborative Efforts?

Partnerships between clinical research organizations and advocacy groups have been instrumental in promoting accessibility. These collaborations ensure that trials address the needs of participants with disabilities and include their input in trial design.?

The partnership between Medicover Integrated Clinical Services and patient groups has led to the development of accessible trial sites and materials, setting a benchmark for industry practices.?

By leveraging these advancements, clinical research is steadily moving toward a more inclusive future, where individuals from all walks of life can participate in and benefit from scientific innovation.?

Recommendations for Future Improvement?

To further enhance accessibility in clinical trials, the following steps should be prioritized:?

1. Accessible Trial Sites?

Ensure trial locations comply with accessibility standards, such as providing ramps, elevators, accessible restrooms, and navigational aids for visually impaired participants.?

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