DE&I in clinical trials: the role
of health literacy and AI

Ensuring clinical trials are representative of all who may benefit from the resulting treatments is both an ethical and a scientific necessity.

Time pressures and budgetary constraints can sometimes lead to deprioritisation of diversity, equity and inclusion (DEI), so how can we effectively address this challenge?

At Precision Medicine Group (PMG), DEI is a key consideration across the drug development process, especially when it comes to patient engagement in clinical trials. We start with insights and a firm understanding of the patient perspective and build from there. But what does this mean in reality?

Effective inclusion of patients may involve proactive engagement with myriad underrepresented communities, considering characteristics such as patient race, ethnicity, gender, age, sexuality, disability status, socio-economic status, pregnancy status and religion. Seeking to fully understand barriers to enrolment and proactively planning to overcome them, operationally, scientifically and from a budgetary perspective, are all critical to success.

It is well documented that members of many underrepresented communities lack trust in the healthcare system and pharmaceutical industry. Patients may also face barriers related to stigma and discrimination, struggle to access much-needed support and to obtain trial details that meet their information needs. Addressing these challenges requires a multifaceted approach that considers inclusivity at every stage of the trial process. This is where consulting with a diverse range of patients at the start of a trial, alongside co-creating materials, can pay dividends in the long term.

Health literacy principles are always useful when communicating with patients and can be even more important when meeting the needs of some patients from underrepresented communities. PMG trains all team members working in patient engagement on these guidelines to ensure they are embedded. Key points include:

• Plain language: avoid jargon, use a clinical research glossary, assume a reading age of nine
• Readability: use short sentences and paragraphs, no more than two syllables in a word and no more than ten words in a sentence, where possible
• Visuals/formatting: include relevant, simple, diverse and inclusive images; use bullet points; break information into clear sections and make good use of white space to avoid information overload
• Cultural competence: understand the background of your participants, avoid assumptions about beliefs, practices and preferences, use culturally sensitive language and consider practical needs.

To ensure that trials are both inclusive and scientifically robust, DEI should ideally be built into the fabric of the trial from the beginning; however, all strides towards inclusive trial practices are important. Continued efforts to improve DEI in clinical trials will ultimately lead to better health outcomes, empowering access to potentially life-changing medicines for all.

If this has sparked your thinking and you’re interested in discussing this topic further and exploring how PMG may be able to help you, please get in touch:
claire.paling@precisionaq.com;
rosamund.round@precisionformedicine.com

References are available on request.