Diversity and inclusion in cancer clinical trials

Transcript

Good morning or good evening, depending on what part of the world you are dialling in from today. Or as my community greets one another, As-salamu alaykum. Peace be with you.

I would like to begin by acknowledging the traditional custodians of the land from which I am dialling in from today, the Darug people, and pay my respect to the Elders past and present, acknowledging them as the traditional custodians of knowledge for this land.

Okay, so first up a bit about myself. I'm a first-generation Australian of Lebanese heritage. My parents migrated to Australia in the late seventies, and I was born and raised in South West Sydney. I have a background in lab-based research, having completed my PhD in cancer biology and therapeutics in 2017. And I've made the transition into clinical research by joining the Cancer Symptom Trials Collaborative, based at the University of Technology Sydney, in September 2019. I am leading research projects in the three topics listed here. And so today, I'll be talking to you about what we are doing in this space and provide some tips and practical steps as we all work towards making our clinical trials more inclusive.

So let's look at the statistics. According to Australia's 2021 census data, our country became the first migrant majority English-speaking country, whereby more than 50% of our residents were either born overseas or had a migrant parent. We have about 5.8 million people that use a language other than English at home, and of these about 880,000 reported having a low English proficiency.

The most commonly spoken languages in Australia after English are Mandarin, Arabic and Punjabi. If we look over to the UK 2021 census data, you'll see that we have similar figures, with about 5 million people speaking a language other than English or Welsh at home, and about a fifth of these reporting low English proficiency. The most commonly spoken languages were Polish, Romanian, Punjabi and Urdu.

Now, what this data means from city to city varies. What we know is that people from these linguistically diverse communities are not evenly distributed; rather, they cluster in certain regions. If we look at a local example, the South Western Sydney Local Health District, which is the largest and fastest growing health district in metropolitan Sydney, we have a total of 966,000 people, and more than 50% of this population is from a non-English speaking background. The 2019 report for this district revealed that approximately 10% of the population had low English proficiency, with a higher proportion of those in people aged over 65. Of relevance to my research and this presentation is that Arabic is the most commonly spoken language at almost 10% of the population, so approximately 96,000 in this district. This actually accounts for more than 25% of people that identified as having an Arabic-speaking background across the nation.

Despite our country's growing ethnic diversity, culturally and linguistically diverse communities, or CALD communities, continue to experience poorer healthcare access and outcomes. With these communities being clustered in certain regions, further pressure is added to an already strained healthcare system. The literature has identified several factors contributing to these health inequities, including widespread communication barriers, a lack of culturally and linguistically appropriate resources such as disease and treatment-related information, the need for resources and training for clinicians to provide effective intercultural care, and a health system that is established on a culturally dominant model of care and is difficult for patients to navigate. I've included a little explanation for what is meant by culturally dominant in the bottom corner here.

A critical component to addressing these health inequities is the conscious inclusion of CALD communities in potentially life-saving clinical research. Diversity and inclusion in clinical research is on both national and international agendas, and reports and recommendations such as this one, recently released by the Australian Clinical Trials Alliance, are being published.

But in conversations with local clinical research groups, one of the first questions I'm being asked is, where do we start? Or should we be translating, or start by translating documents and resources? My advice for the first question is to get to know your population better. Who are the people likely to be accessing the health services at your current clinical sites? Or perhaps you need to be looking at opening your studies for recruitment at clinical sites within regions that have a high proportion of CALD communities. Take the research to the community.

For those of you with disease-specific research, refer to prevalence data, if it exists, to determine what CALD communities are likely to be impacted by this disease. In doing so, this will allow you to unlump CALD communities, because CALD is quite broad and there are lots of sub-communities within that category. By doing this, you can take a more tailored approach. For example, we have decided to start with the Arabic-speaking population initially, and we hope to expand to other communities as we progress.

With regards to the second question, when we think about solutions for inclusive clinical research, we often fall into the trap of hyper-focusing on the language component, but very little attention is given to or is known about the cultural or spiritual aspects of the community and how this influences decision-making around new treatments or participating in clinical research. Even individuals like myself, who can speak English fluently, still experience those cultural and spiritual barriers.

Translating promotional materials and things like your participant information sheets and your patient-reported outcome measures will no doubt address some of those language barriers, but if your study design has not taken into account cultural or spiritual sensitivities of the community you wish to recruit from, then you will potentially run into some feasibility issues. What you should be doing is engaging with the community first. I'll come back to this point in a later slide.

You also want to be co-designing any sort of messaging or resources to ensure that you are getting the information across effectively and in a culturally appropriate manner. Just recently, last week, I attended an event hosted by an Arabic Translators and Interpreters Association here in Australia. A key theme of the discussion was that although translators were able to accurately translate English to Arabic, coherence was a major issue. The message was literally getting lost in the translation. This could be resolved if translators are included as key stakeholders in the co-design process, rather than just being contracted to translate the document.

This guidance document was brought to my attention and has some tips for those of us developing English documents for translation. The link to the PDF is provided below, and I believe you will be receiving a copy of these slides.

For the remainder of my presentation, I will provide you with some insight into and unpack some of those cultural and spiritual nuances within the Arabic-speaking Muslim community, as well as general strategies that may help you progress towards inclusive research design.

To kick things off, I'm going to briefly touch on language because it can provide an insight into culture. I'm going to introduce you to two Arabic words. But first, Arabic is not a single language. In Australia, the Arabic-speaking community is quite diverse, with origins from over 22 countries. While there are some common terms, Lebanese Arabic, for example, is very different to the Arabic spoken by people from Iraq. In addition, each will have their own cultural influences. This is important to factor in when translating materials for your studies and when engaging interpreters to interact with participants.

Now, going back to the two Arabic words I want to introduce you to. The first is the Arabic word for cancer, which is pronounced as Saratan. In the Lebanese community, the word Saratan is rarely used by patients, carers, family or friends. In conversations, people often have a more serious or pessimistic tone, lower their voice to almost a whisper, and a lot of the time, replace the word entirely with a phrase pronounced as Hedek el marad, which literally translates to "that disease" or "that illness". So really, we are a community who are not yet comfortable saying the word cancer in our own language. There are incredible levels of fear, negativity and pessimism tied to this disease, to the point that we won't even utter its name, even after a loved one has passed away.

What does this mean for us as clinical researchers? Translated materials, or even conversations and assessments with clinicians, researchers, interpreters, etc., can be quite confronting. We need to ensure that cultural sensitivity and appropriateness is front of mind when designing our studies and resources, and when interacting with the community.

Another word I want to introduce you to is Ajnabi. If you were to ask Google Translate how to say "white person" in Arabic, it will give you something entirely different. But I know that in several Arabic-speaking communities, the word used to describe Westerners or white people is Ajnabi. The literal translation is "stranger" or "foreigner". By definition, by default, there is already a level of mistrust.

What I want to highlight from this point is the importance of ensuring diversity within your investigator teams and site staff—someone that people from the CALD community you wish to recruit from can relate to and trust. Someone that not only looks like them and speaks the same language, but also understands them and their cultural or spiritual values. Someone who won't be perceived as an Ajnabi or a foreigner. A very quick exercise you can all do is survey your current research and site staff. How diverse are your teams currently, and what are the in-house community connections and language skills you can leverage?

If we look at some broader systemic issues, is there a skills shortage? Let's address that. How can we upskill individuals or professionals from CALD backgrounds working in health to be involved in clinical research or academia? What opportunities can we create for these individuals to progress into leadership roles? These are systemic gaps that, if we address, will allow for a more holistic change within the clinical research landscape.

Now, let's go a little deeper and look at the spiritual aspect. The Islamic faith teaches us that our body is on loan—a temporary vessel which we are required to protect and preserve, so much so that changes to the natural form, such as getting a tattoo, are not permissible. Health complications are viewed as a test from God and a blessing, providing a means of cleansing one's sins. When it comes to clinical research, we're balancing the risks and benefits—not just the medical implications, but also the religious implications. Instinctively, one would question whether this is permissible. Where there is religious ambiguity, the common response is to exercise caution and avoid where possible.

So, coming back to participation in clinical research, sometimes the decision-making process will consider the views of a religious or community leader, and a lot of the time it is a family decision, not an individual one.

Western medicine or research leans towards the notion of survival at all costs. In Islam, the concept of survival is not confined to life on earth. We believe this life is a stepping stone towards the afterlife, for which we are expected to prepare. For example, the duty to be of service to others, usually in the context of helping the less fortunate. There is an opportunity here: if we tie this back in with clinical research, which benefits future generations, then we can frame our messaging to align with this religious and moral obligation, especially in the context of palliative clinical research.

This is a great segue to the importance of community engagement and getting to know your population better. Building community relationships and trust is a process. It takes time—anywhere from weeks to months to years in the making. The events of the last few years with COVID have seen mistrust and fear of the health system and research sector in general skyrocket, especially in CALD communities. We have a lot of work to do to rebuild that trust.

If I could leave you with one bit of advice around community engagement, it would be to engage as early as possible. Do not approach the community with your predetermined priorities and solutions a few weeks out from submitting a grant. Take the time to listen to their needs and priorities, appreciating their cultural and religious context, and generate solutions that consciously factor these considerations.

Finally, your clinical trial designs: keep diversity and inclusion front of mind when drafting those protocols. Plan ahead. For example, you may want to factor in community engagement activities, translations, medical interpreters, and patient navigators into your trial design, and make sure you've accounted for the associated costs—not just in terms of funding, but also the time it will take to progress with all of this. Consider the use of patient-reported outcome measures that are available in translated and validated versions. For some guidance, I refer you to take a look at the Cancer Quality of Life Expert Service, or C-Quest, that is also based at the University of Technology Sydney. They have compiled a list of PROs, and it is publicly available on their website.

This is not a comprehensive list of strategies, rather some initial steps that you can take today. Just remember, we are all responsible for ensuring CALD communities have a voice in and have equal access to health research.

This last slide provides a link to our webpage for our diversity and inclusion program of research. To date, the literature has mainly focused on the patient-sided barriers and enablers to clinical trial participation in CALD communities, and very little attention has been given to the sponsor or site-level barriers and enablers. For our first study, we have chosen to focus on the Arabic-speaking population in Australia, and we are currently recruiting healthcare professionals across the nation to gain insight into their experiences with this community in the context of research participation. This study is ongoing, and unfortunately I do not have data to share with you today, but we will post updates to our website and to our social media pages as things progress. Thank you.