Making Clinical Trials User-centric for Diverse Patients

While watching a recent workshop on enhancing diversity in clinical trials, I was struck by the passion of one of the panelists. She belonged to a minority community and was a breast cancer survivor. “There are a large number of breast cancer cases in my community. Yet, breast cancer clinical trials don’t include members from my community sufficiently.”

Surprised?

You know that clinical trials test the effectiveness of a medical treatment on human beings. A medical treatment goes through rigorous research before regulatory bodies approve it. Medical treatments may affect patients differently. You would expect clinical trials to include diverse patient groups and study how they respond to the medical treatment.

Yet, researchers lament that diversity in clinical trials has been a perennial challenge. 

Why?

Researchers have mentioned several reasons. Some of these are: lack of awareness among patients, mistrust about clinical trials, site’s geographical location, culture, language, race, ethnicity, and perception.

Research states that perceptions of diverse patient groups about a clinical trial may differ. Understanding these different perceptions is important. Clinical trial stakeholders have run into problems because of these differences. Recent guidelines require stakeholders to submit upfront the effectiveness and safety of their study design for diverse patients in their study.

It’s here that experiential designers come into the picture. They design by addressing the pain points, needs, and aspirations of users. We’ll take the example of the consent form and look at it from an Experiential Design perspective.

A consent form typically describes the clinical trial, its benefits, and risks. Participants sign their consent on this form.

Imagine that you are the sponsor of a clinical trial on breast cancer. The study design includes women from diverse races to understand how they respond to the medical treatment. You want the form to talk to the readers’ diverse cultural perceptions. You hire experiential designers to design the form.

Designing the consent form

Experiential designers see the form as a conversation between business stakeholders and patients. Understanding both perspectives helps them design an engaging conversation. The process they follow is rigorous. The highlights of their process are:

• Talking with stakeholders – Discussions with business stakeholders give them insights into the clinical trial’s vision, business objectives, problem areas, diverse patient populations, priorities, and processes.
• Defining success metrics – How would they know that diverse patients found the form engaging and helpful? Experiential designers define the success metrics.
• Undertaking user research – The users here are patients. Experiential designers observe and talk to patients across diverse groups. The research gives them insights into their pain points, aspirations, and expectations. They understand patients’ cultural perspectives better. The research also gives experiential designers glimpses into patients’ sensitivity. The sensitivity informs their work. Talking to patients also informs designers whether any additional patient population should be included.
• Designing personas and journey maps – The user research helps them in designing personas. Further, it helps them design journey maps to explore how to provide patients with a good experience as they read the consent form.
• Ideating – Experiential designers come up with ideas and create wireframes for the consent form. They want the tone to be reassuring and comforting. Insights into patients’ sensitivity gained during user research help them choose words, colors, and images. They also think about accessibility. The question they consider is, ‘How can we best present the content to ensure easy readability?’
• Conducting usability testing – Any User Experience design cannot be good unless experiential designers observe and study how real users use the design. Experiential designers conduct usability testing with the form’s wireframe or prototype. Usability testing helps them find answers to several questions. Are diverse patient groups finding the form easy to understand? Are diverse patient groups interpreting the content the same way as the sponsor? How are they feeling? Is there something that is upsetting them? What actions do patients want to take after reading the form?

The analysis helps experiential designers to improve the form further. There are several iterations. Each iteration makes the design more user-centric. Each iteration brings the design closer to business stakeholders’ priorities.

Want to make your clinical trial more user-centric for diverse patient groups? Engage with experiential designers at Persistent.

Partnering with Persistent

Persistent has worked with 500+ customers over 15 years in designing delightful user experiences.

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