By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
One of the biggest challenges drug developers will face in 2021 and beyond is the inclusion of more minority patients in clinical trials. The COVID pandemic has put a spotlight on diversity, with a disproportionate number of African Americans contracting the virus while still being underrepresented in treatment and vaccine trials.
It has always been difficult for pharma to recruit minority patients, and this continues to be a struggle. Karen Bass, congresswoman from CA and chair of the congressional black caucus, recently wrote about the problem in the Washington Post. She outlined the issue of inclusiveness in trials and laid this problem right at the feet of the pharma companies. Now seems to be the time for sponsor companies to address this situation and do something about it.
Sponsors are certainly making efforts to include more minorities, and I have produced content on those efforts. For example, many companies are making patient diversity part of their trial planning process and are even working with recruiting agencies. Still, healthcare disparities exist, and the diversity issue will not resolve itself. Over the next several years the industry must figure out different ways to improve access to healthcare and educate the public on the benefits of clinical trials.
Diversity is now a priority for regulators, and political pressure will continue to increase. The article by congresswoman Bass is just one example. Pressure from politicians, regulators, and patient advocacy groups will continue to build.
Start With Healthcare
The big question, of course, is why pharma has not been more successful at recruiting patients of color. For that answer, one place we may need to look is access to healthcare.
In the U.S. equality of access to healthcare does not exist. Some minority populations do not have primary care physicians. Instead, an emergency room visit is standard and doesn’t typically promote clinical trial participation. There is also a history of distrust of pharma, government, and healthcare going back to the Tuskegee syphilis experiments and more. Add to that the fact that most patients find out about trials from their physicians, and African Americans are underrepresented in that field.
A network connection recently told me about a university dean who wanted to be one of the first to test a new COVID vaccine undergoing clinical trials at the school. She asked her administrative assistant, an African American male, if he also wanted to take part. He declined to participate, noting she would likely be given a different medication than the one he would receive.
That one example is representative of the trust challenge faced by pharma. The statement came from someone who works for a university, and those sentiments are not uncommon. That university is also situated in a very affluent part of the state. There is not one reason why minorities opt out of trials. There are a number of factors.
Complex Problems Require Complex Solutions
The solution to the diversity problem will not be a simple one. It is going to require a broad coalition of pharma companies, healthcare centers, physicians, and politicians to take a hard look at healthcare in this country. One of the trends that will continue to evolve is clinical research as a care option.
If minority populations have better access to the healthcare system, the opportunity for them to be exposed to trials increases. There are some clear root causes for why we do not have minority participation in trials, and equal access to the healthcare system is one of them. Pharma companies need to ensure they are going after the root causes. If they don’t, we will be in this same position five years from now. Which, unfortunately, is similar to the position we were in 10 years ago.
Thus far the FDA has not done much to crack down on drug developers that do not increase trial participation by minorities. It also seems unfathomable that any regulator would delay the approval of a life-saving medication simply because trial participants were not diverse. Still, the challenge cannot be ignored.
One industry executive told me he was once part of a working group that engaged with the FDA to try and understand how to increase diversity in clinical trials. The group met with the regulator on several occasions and simply could not produce any concrete ideas that someone had not already tried. Although stakeholders involved with clinical trials have a strong desire to fix the problem, coming up with solutions can be difficult.
A Three-Pronged Approach
I have spoken to many experts in the industry on this topic. While pharma companies can’t single-handedly change the equality issues in healthcare, there are things they can do to move the needle on patient diversity. Addressing these three issues may lead to changes that can eventually create more trust in minority patients and lead to greater access to them.
First, there needs to be a broad coalition of focus on engaging with minorities in their communities. This engagement must focus on meeting individuals in person, learning about their healthcare needs and where they get their information, and understanding their concerns. This will increase the level of trust many have in pharma and the entire healthcare system.
There is another reason for the industry to support a broad coalition that could focus on minorities as well as patients, sites, and physicians across multiple therapeutic areas: It is one of the ways the industry can build trust among patients, clinics, and physicians.
Second, Americans in general need to be better educated on clinical research and trials, especially those who live in ethnic communities. For minority participation in trials to increase, non-white communities need to be better educated about clinical trials and the healthcare system. Pharma needs to play a role in that education process by reaching out to minority communities and making clinical trial information available to them. Getting over the distrust of trials will be a challenge, and pharma companies must play a major role in that educational process.
Finally, clinical sites need to be located in close proximity to minority communities. Pharma cannot continue to recruit from the same sites they have in the past, and must move past confining their recruitment efforts to major universities and medical centers. A higher density of these clinics will provide access to minority candidates, increase access to healthcare, and provide the needed educational opportunities. Pharma must then focus recruitment efforts on those clinics.
Instituting these three steps will neither be quick nor inexpensive. There will need to be an investment of time, resources, and money over a sustained period of time. A long-term approach to developing collaborations with these stakeholders will go a long way towards building trust and engaged patient networks. The time to start is now.