November & December 2020: Diversity and inclusion in clinical trials round-up


Diversity in Clinical Trials

This round-up brings a mix of articles, including how medical mistrust is causing reluctance for the COVID-19 vaccines, the impact of criminalising immigration policies on healthcare inequities, why everyone may not have the opportunity to access the potential of precision medicine, and much more. Read on to find out the latest news surrounding diversity in clinical trials as we bring 2020 to a close.



New guidance released from the FDA

Underrepresentation in clinical trials is no new issue, however recent efforts by the FDA have aimed to finally address and resolve this unmet challenge. This article summarises the new changes that have been outlined in the guidance.


1. Broadening eligibility criteria to increase diversity in enrolment

The guidance begins by outlining ways pharma companies can improve their enrolment practices to enhance diversity. The FDA acknowledges that whilst it is sometimes necessary to exclude people from trials over safety concerns, all too often, trial designs reuse the same template instead of reviewing and tailoring the inclusion and exclusion criteria to the trial. Here are the recommendations made by the FDA:

  • Inclusive trial practices – Consider eliminating or modifying criteria to expand the study population, review exclusion criteria when moving from phase II to phase III, and ensure eligibility criteria closely mirrors the population the drug aims to treat.

  • Trial design and methodical approaches – Consider characterising drug metabolism and clearance across different populations, and use an adaptive clinical trial design to accommodate any changes.

  • Implement enrichment strategies – Demonstrate the efficacy of a drug through targeted inclusion of specific populations.


2. Considering study design and conduct to improve enrolment

Study design and clinical trial conduct can also have an impact on patient enrolment, so the FDA recommends adopting enrolment and retention practices that will make trial participation less burdensome for patients, whilst also enhancing inclusiveness.


3. Broadening eligibility criteria and encouraging recruitment for clinical trials of investigational drugs intended to treat rare diseases or conditions

Finally, the FDA addresses the challenges in ensuring diverse representation in clinical trials investigating drug for rare diseases. As patients with rare diseases are few and far in between, it can be difficult to make sure all populations are fairly represented. The FDA suggests changes to implement in the enrolment process to improve this, including re-enrolment of participants from earlier phases and engaging with patient advocacy groups.

To read the full summary of the new guidelines, click here.


The first industry-wide principles released by Pharmaceutical Research and Manufacturers of America (PhRMA)

PhRMA have added a new chapter to their principles, entirely dedicated to enhancing diversity in clinical trial participation. The principles mainly focus on four key areas, each aiming to tackle different barriers to diversity and inclusion. These are:


1. Building trust and acknowledging past wrongs

PhRMA begin by explaining how historical treatment of Black and Brown communities has led to significant mistrust against the industry, and have outlined commitments to improve this:

  • Enhancing education and diversity among clinical investigators

  • Increasing clinical trial awareness and diversity by improving individual health literacy and community outreach


2. Reducing barriers to clinical trial access

Through simple changes in clinical trial practices, PhRMA highlights ways to encourage greater diversity in clinical trial participation by:


  • Adapting enrolment and retention practices that enhance inclusiveness and make trial participation less burdensome for patients

  • Considering the needs of diverse populations in clinical trial design

  • Broadening eligibility criteria


3. Using real-world data (RWD) to enhance information on diverse populations beyond product approval

There is potential for that the use of RWD could enhance understanding of drug effects in diverse populations in the post-approval phase, which would quickly highlight any disparities in drug efficacy and toxicity.


4. Enhancing information about diversity in clinical trial participation

Lastly, PhRMA encourages pharma companies to not only adopt these principles, but to establish company policies to reflect them.


To read the full summary of PhRMA’s new principles, click here.



The pandemic won’t end when we have a working vaccine, it will end when everyone is vaccinated

Pharma and biotech companies across the globe have been racing to produce a vaccine to bring this pandemic under control. And with vaccinations now on the horizon, we must begin the work of undoing widespread hesitation of vaccinations. After all, what is a vaccine worth if people choose not to take it?


Recent studies have highlighted concerns over reluctance to get vaccinations in ethnic minority groups. Worryingly, half of Black adults are against getting a COVID-19 vaccine. This reluctance isn’t due to concern over the efficacy of the vaccine but has everything to do with fears over its safety.


Medical mistrust is deeply rooted in ethnic minority communities, and there are clear barriers that are actively preventing trust from being rebuilt surrounding COVID-19 vaccinations:


  1. The pandemic has led to a quicker than usual development process – this could create a misleading impression that corners are being cut in terms of efficacy and safety of the vaccine.

  2. It’s unclear whether ethnic minorities are being represented in clinical trials – to understand the true efficacy and safety of a drug, it must be tested in a patient sample that reflects the population it aims to treat.

  3. The public health community has yet to overcome the rightfully held anger surrounding the Tuskegee Syphilis Study


To further understand the barriers preventing ethnic minorities from placing trust in the healthcare industry as a whole, read the full article here.



How should COVID-19 vaccines be prioritised in people of colour?

Those at the top of the list to receive vaccinations against COVID-19 include the elderly, frontline healthcare workers in nursing homes and hospitals, and those with chronic conditions. These people are being prioritised as they’re at high risk of becoming infected and suffering with serious conditions as a result. However, ethnic minorities have been disproportionately affected by the virus, so should ethnic minorities also be considered a top priority for the vaccine?


Having a racial preference for a COVID-19 vaccine is not only ethically permissible, but I think it’s an ethical imperative.” – Laurence Gostin, Professor of Global Health Law at Georgetown University.

However, there are distinct concerns over potential barriers in doing so. For example:


  • There are concerns that vaccine allocations based on race and ethnicity could be disrupted due to legal objections – legally, public health agencies cannot distribute vaccines to geographical locations solely based on race.

  • Ethnic minority groups, especially Black people, may be reluctant to get the vaccine first – due to historical treatment of Black patients in medical research, there is profound medical mistrust to be overcome in these communities. There is the potential that these communities may perceive having first access to vaccines as being experimented on.


To understand more about the challenges in prioritising vaccinations in the communities that need it most, and the potential framework to guide vaccine allocation, read the full article here.



How criminalising immigration policies can impact healthcare inequalities

Recent research has highlighted that US citizenship status is an influential factor in determining healthcare outcomes. Citizenship is simply a status of a person within a nations ever-changing structure of social rights and belonging, yet it’s become an important factor to consider when addressing healthcare inequities.


This has largely to do with access to care. Undocumented immigrants are less likely to have insurance and a usual source of care when compared to documented immigrants and US born citizens, and are therefore restricted as to what care they are able to access. This isn’t new information; research has been suggesting this for years. However, one area that hasn’t received the same level of focus is criminalisation policies.


Criminalisation policies that target immigrants can also impact the nature of citizen stratification. This means that when there are stricter criminalisation laws within a given state, the health inequities between citizens and noncitizens are greater.


To learn more about how criminalisation policies have an impact on healthcare inequities, read the full article below.



How to build trust in patient engagement

A panel of experts from research organisations, community health centres (CHCs), and healthcare tech came together to discuss the underrepresentation of ethnic minority groups in clinical trials, and how the industry can improve equity in research. We’ve selected a few of the questions that were discussed below:


  1. What is the best way to get healthcare providers (HCPs) to promote research with their patients? Simply put, the most effective way to promote research with patients is to discuss clinical trials with them. Normalising this discussion and increasing public awareness around clinical trials is key to improving overall and diverse recruitment.

  2. Is there a way to set up CHCs as research sites, so patients don’t need to leave their community or HCPs to participate in a trial? The decentralisation of clinical trials is growing ever more popular, with hybrid approaches involving centralised sites coupled with secondary sites to lower administrative burdens.

  3. How do we, in clinical research, work to build trust collectively? The historical treatment and exclusion of ethnic minority groups in clinical trials has resulted in these communities having an understandable amount of mistrust. We should work to measure and incentivise true engagement and education, and ensure that recruitment plans prioritise this.

  4. How do we start building funds into budgets and grants for researchers to access translators and transportation etc. as standard practice? Researchers should adjust templates and expectations to normalise budgeting for these across the different phases. There is also benefit in encouraging researchers to revise their internal estimates for study budgets.


To learn more about how to build trust and improve diversity in clinical trials, read the full Q&A here.



Healthcare disparities and the potential of precision medicine

Advances in precision medicine have already led to new discoveries and several new treatments that are tailored to an individual’s specific characteristics, such as one’s genetic makeup or the genetic profile of an individual tumour.


However, while precision medicine comes with great promise and premises for improving population health, it also comes with the risk of exacerbating health inequalities, particularly between racial and ethnic minority groups.


Research has shown that the lower participation of minority groups has contributed to most genetic databases that are used for research purposes predominantly contain data on participants of European ancestry. And there are concerns that genetic and genomic testing and services will not reach all segments of the population.


This article then goes onto explain the major obstacles to accessing genetic testing and the corresponding downstream care, and what can be done to address this to ensure everyone has an equal opportunity to access the opportunities that precision medicine brings. Read the full article to learn more.



Discussions around diversity and the power of simply “asking”

In this article, we get an inside look into a recent conversation between two Roche colleagues - Severin Schwan, CEO of Roche, and Yvette Miata Petersen, Chief of Staff and Transformational Lead, Pharma Research and Early Development – as they discuss what diversity and inclusion means to them and Roche.


Severin begins with:


“I truly believe that diversity enhances innovation. Because if we have different backgrounds, if we have different experiences, that creates a diversity of thinking, that creates the different perspectives which are so fundamental to coming up with creative solutions.”

They then go on to explain that they have one ambition at Roche that’s focused on diversity, and explain how they’re going to get there, to which Severin highlighted that diversity is not an afterthought:


Diversity for me is not an addition to our objectives, or an afterthought, but part of who we are, how we do our business and what we want to accomplish.

As a Black woman, Yvette also explained that many of her colleagues have admitted to diversity and inclusion being a difficult topic to address, saying things such as “I don't know what to refer to you as. Can I call you Black, Afro-American, American?” And Yvette simply says to them: “Just ask me!” This suggests that the power of simply asking, being open and honest, and having those personal conversations can really go a long way.


Read the full conversation to learn more about how Roche are embracing diversity.



The first industry-wide principles released by Pharmaceutical Research and Manufacturers of America (PhRMA)

PhRMA have added a new chapter to their principles, entirely dedicated to enhancing diversity in clinical trial participation. The principles mainly focus on four key areas, each aiming to tackle different barriers to diversity and inclusion. These are:

1. Building trust and acknowledging past wrongs

PhRMA begin by explaining how historical treatment of Black and Brown communities has led to significant mistrust against the industry, and have outlined commitments to improve this:

a. Enhancing education and diversity among clinical investigators

b. Increasing clinical trial awareness and diversity by improving individual health literacy and community outreach

2. Reducing barriers to clinical trial access

Through simple changes in clinical trial practices, PhRMA highlights ways to encourage greater diversity in clinical trial participation by:

a. Adapting enrolment and retention practices that enhance inclusiveness and make trial participation less burdensome for patients

b. Considering the needs of diverse populations in clinical trial design

c. Broadening eligibility criteria

3. Using real-world data (RWD) to enhance information on diverse populations beyond product approval

There is potential for that the use of RWD could enhance understanding of drug effects in diverse populations in the post-approval phase, which would quickly highlight any disparities in drug efficacy and toxicity.

4. Enhancing information about diversity in clinical trial participation

Lastly, PhRMA encourages pharma companies to not only adopt these principles, but to establish company policies to reflect them.

To read the full summary of PhRMA’s new principles, click below.

[Read more]