Should diversity in clinical trials be mandatory? A panel discussion summary report
In November 2020, we were honoured to take part in an important panel discussion to address the current situation around diversity in clinical trials, and share our views on what can be done to make a better future for the populations we seek to serve.
In the Road to Equality panel discussion, our very own Ash Rishi — CEO of COUCH Health and Demand Diversity — joined a panel of representatives from across the health and research sector, who share the same passion to do their part and improve diversity in clinical trials:
Chi Onwurah — MP and Shadow Minister for Digital, Science & Technology
Charles Kwaku-Odoi — Chief Officer at Caribbean and African Health Network
Josiane Chuisseu — Head of Sales, BioPharma of Source Bioscience
Ash Rishi – CEO and Co-Founder of COUCH Health and Demand Diversity
Moderated by Annette Jack — CEO and Founder of Egality Health
Chaired by Kate Shaw — CEO of Innovative Trials
Together, COUCH Health, Egality Health, and Innovative Trials — a joint-working collaboration determined to improve representation in UK clinical trials — set out to answer key questions, covering what it would mean to make diversity a mandatory policy, and the impact this would have on both the industry and global population.
Current diversity in clinical trials
The panel discussion began with an overview of where the UK currently stands with diversity in their clinical trials, and some stats that certainly put things into perspective.
In England and Wales, people from black, Asian and minority ethnic communities and those of mixed ethnicity account for 14% of the total population. Unfortunately, much research shows that this is not reflected in clinical trials:
One study found that only around 5% of respondents from ethnic minority groups in the UK had ever participated in medical research
A review of 12 diabetes trials found that the mean South Asian involvement was 5.5%, despite South Asians representing 11.2% of the UK population and disproportionally suffering from diabetes. Also only 4 of the 12 studies did not report ethnicity data
In June 2020, a review of 1518 COVID-19 studies registered on ClinicalTrials.gov, showed that only six were collecting data on ethnicity.
And in the recent COVID-19 pandemic, research suggests that diversity in clinical trials is more relevant than ever:
In April 2020, one in three critically ill COVID-19 patients in hospital in the UK were either from an ethnic minority background or of mixed ethnicity
In October 2020, of the 270,000 people already recruited to coronavirus vaccine trials, only 7% were ethnic minorities
From a £4.3m fund to research COVID-19 minorities and ethnic minority communities, £0 went to Black principal investigators
With these statistics in mind, it’s clear that there’s a need for diversity in UK clinical trials. So, is a mandatory policy the solution? Keep reading to find out what the panel discussed.
What does making diversity in clinical trials mandatory mean for you?
Across the panel, there were mixed responses. However, we all agreed that something needs to be done for clinical trials to be more diverse and representative of the populations we are targeting. There was a general agreement that if not made “mandatory”, then diversity should certainly be encouraged, and action for this needs to be taken sooner rather than later.
Chi highlighted that improving diversity is all about having the processes, principles, resources, monitoring and enforcement in place. She also highlighted that we shouldn’t put pressure on communities to volunteer and we should avoid “blaming the victim”. She emphasised that achieving diversity is the industry’s responsibility, and they need to be effective in reaching those communities.
Charles believes that making diversity mandatory is important for the populations we seek to serve. He believes if inclusivity is taken seriously, there will be better outcomes, which will allow us to save costs and provide many additional benefits in the long run. He also emphasised that it shouldn’t be a tick-box exercise: if diversity is made mandatory, consistent monitoring should be ensured to check that actions are linked to increased diversity.
Josiane was very strong-minded in terms of data being important for us to make informed decisions. With informed decisions, we can take action and make powerful, long-term change. And while Josiane isn’t sure on the word “mandatory”, she certainly believes diversity should be enforced. She provided an example of how this could be done by enforcing it to be “the norm” that side effects for certain ethnic groups are listed on medication packaging.
Ash raised an important point that by 2031, 37% of London’s population will be ethnic minority groups, and 30% of the whole of the UK population will be ethnic minority groups by 2060. And getting things in order now before we reach that point is the reason why it’s so important to him. Because when we do reach that point, we need medicines that will be inclusive for all. Making diversity mandatory is a “no-brainer” for him and he emphasised that while, in November 2020, FDA (and subsequently PhRMA in November 2020) have released guidance in the United States, it’s not having as much impact as it could be, and we could create a larger impact in the UK if we all collaborate together. He also emphasised that diversity isn’t just about ethnicity — there are gender inequalities, the elderly, and LGBTQIA+ communities that need to be considered too.
What needs to happen to make this a mandatory policy for the UK?
Chi explained some of the main things she believes we need to do:
Raise the profile of the challenge and ask the relevant departments what they are doing to ensure diversity in trials
Understand what it would mean for rare diseases; would it lead to additional cost burden on trials? If so, who would pay for it?
Implement it locally to begin with, including medical research centres or by particular organisations/companies, such as Pfizer. That way, we can gather the data and best practices to make it a national policy. We should also ask how they’ve assessed the impact of the mandatory requirement on clinical trials.
Charles emphasised that setting out the rationale is important for making it a mandatory policy. There are various ways we could do this, such as raising questions at the local level, providing the guidance, articulating the benefits, and getting people to set targets.
What would the implications be for the pharmaceutical and bioscience industry?
The general consensus here was that there will be some challenges, but the implications can only be positive in the long run.
Josiane highlighted that while there are concerns about a mandatory policy increasing the overall cost of delivering clinical trials, we need to remember the importance of why the policy is needed in the first place: by thinking about the populations who are affected.
For example, how much would the NHS save if the right medicine and care were targeting the correct segments of the populations? Currently, how much does it cost them to start a trial, then abandon it, because it does not meet the requirements of diversity that is set in the population they are targeting? Josiane raised a very good point that while there may be implications, making diversity a mandatory policy is a great investment opportunity for a company who is able to provide the right sort of medicine and prove that whatever they are putting on the shelf meets the requirements of the target population. It’s a win-win situation: a win for the current systems we have, including the NHS, to involve diversity, and a long-term investment to ensure better equity moving forward.
Ash agreed that both costs and timelines are bound to come up. But going back to “what would mandatory look like?”, Ash believes we should have diversity benchmarks per disease area. If we don’t hit the benchmarks — maybe adding a “warning” sign on the medication could act as a motivator. If we do hit the benchmarks, data will be stronger, regulators will be happier, time to market will be faster, profits will increase, and the medicines developed will be more relevant to the population. Overall, a mandatory policy would bring a more positive outlook for the industry.
What would the impact be for society?
There was mutual agreement that ensuring diversity in clinical trials would only bring great benefits to society.
“A more equal and healthier society.” It would be in the interest of all aspects of society that inequalities are reduced. — Chi Onwurah
“It’s an ethical and moral thing we have to do.” The impact will be a fairer society, where everyone feels welcome. — Charles Kwaku-Odoi
“The impact can only be a positive one.” Currently, GPs will prescribe the same treatment to two people regardless of their background, and hope they’ll respond the same way. But it doesn’t work that way. Someone who is dark-skinned may have a side effect and rashes may not be seen the same way. Josiane says it’s important that whoever walks through a HCP’s door is assured that they will get help if something goes wrong. And the only way that can truly happen, is if diversity is part of the conversations, training and society in the daily basis. So the impact can only be positive. — Josiane Chuisseu
“Imagine a world where whoever you are, whatever background you’re from, you have medicines that work for you.” There are a lot of challenges to tackle along the way, but improving diversity will bring positive impact for the society overall. — Ash Rishi
Below is a summary of just some of the questions from those who attended the panel discussion, and the panellists’ responses.
Who should be leading or driving these mandatory policies forward?
The panellists agreed that the responsibility to do this does not lie with one person. It’s a collaborative effort that requires all hands on deck.
Josiane explained that government bodies should lead with organisations around them. Several corners need to come together to amplify the noise: the pharma industry, the curriculum at universities will have to be impacted, conversations will have to become more common.
Chi believes it should be the medical research councils along with NICE. But she emphasised that they are not going to lead this unless they’re required, and inspired, to do so. Therefore, we all need to take a role to raise the profile of the issue, such as through press coverage and drafting questions to the parliament.
How do we win trust in communities to engage in medical research?
People in the system understand the importance of trust, but it’s being swept under the carpet. We need to do everything possible and put in the resources. We need to go to the right places and show that we understand the communities we’re seeking to serve.
What practical steps would you take to win trust?
Charles believes we should move away from digital communications such as social media, and move towards community engagement, to begin to truly understand and build relationships with different underrepresented groups.
Ash agreed with this approach, explaining that the engagement model in clinical trials is evolving. First, patient centricity happened, but now we need to add in the community groups — “they need a seat at the table.”
How can we impact diversity in trials at a local level?
Josiane explained that digitalisation of clinical research will be essential. Touching upon the COVID-19 pandemic, she explained that we’ve managed to find ways to communicate during lockdown through digital approaches, such as WhatsApp. So why can’t we use this approach for clinical research? Having a siloed approach to clinical recruitment is a barrier, and innovation and thinking outside the box is needed here.
Finally, education is key to building diversity in clinical trials. How do we go about educating everybody about clinical research?
Charles said there has to be a way to maintain the relationship after someone has taken part in a trial, so we can take learnings from the experience and share it with others. We need to be able to take people on the journey, such as why do we want them to take part? What will the impact be? What difference has it made to those who have already taken part?
Josiane emphasised the importance of using the right vocabulary to the right channels. We need to engage with people by using what they already know and expanding with vocabulary that they understand.
Ash believes that we need a country-level, repeated, public health campaign. We need companies to come together and keep fighting the fight.
Closing remarks and the take-home message
It’s the start of a long journey, and each and every one of us will be needed to take action to achieve diversity in clinical trials. Let’s take a look at the take-home messages from some of the panellists:
“Keep driving conversations and asking questions about whether things can be done, regardless of your role.” — Josiane Chuisseu
“Don’t just focus on the costs and profits. We’re dealing with lives. Look at the moral obligation we have.”— Charles Kwaku-Odoi
“No matter your job role, whatever it is that you’re working on, continually ask yourself: ‘Is this inclusive of everyone?’ That in itself should get us far.” — Ash Rishi
While there are differing opinions, one thing that we all agreed on is that diversity needs to improve in UK clinical trials. There are already clear opportunities to help do this — whether it’s improving data, through digitalisation of clinical trials, or sharing best practices that’s already happening in local areas. But ultimately, it has to be underpinned by rebuilding trust in communities.
We’d like to thank everyone who attended the webinar, which is now available to watch on demand . And as we plan for the next stage of our campaign, we look forward to seeing what the future holds.