A past, current, and future problem – underrepresentation in clinical trials, particularly for rare diseases.
Why does representation matter? Besides, you know, the basics of equality, drugs can react differently among diverse individuals just as illnesses can. Therefore, its essential to distinguish the best treatment option for the various types of individuals effected.
Unfortunately, underrepresentation has been an issue for quite a long time.
The Past Problem
A history of non-inclusive trials means we don’t have concrete scientific records of how some drugs react in diverse groups of individuals.
The Current Problem
Current non-inclusive trials means people of color are being inhibited from receiving a treatment alternative which could be one of their last options. Even if its not one of their “last options”, they should have the same freedom of choice as everyone else.
The Future Problem
Continued allowance of non-inclusive trials means a continued delay in information about drug effectiveness and safety for all. Additionally, it continues to limit opportunities for people of color.
The “wait till the drugs on the market” argument
Some argue that the lack of representation can be made up once the drug is on the market. Here’s 4 reasons why that’s not a good idea. Hopefully, at least one resonates with you.
The practicality argument- Why would we wait to right a wrong when we can make it right in the beginning? Especially when ensuring inclusivity would not be a complicated or difficult fix.
The humanity argument- We’re literally waiting until someone to gets hurt when we have the option of prevention.
The financial argument- It can often cost more money to rerun a trial when we find out a drug is doesn’t work well for people of certain ethnic backgrounds. The cost is much more minimal if we’re simply inclusive from the start.
The equality argument- Equality has to come at every step in the process. For some, clinical trials are their only option; they deserve access to that option as much as any other individual.
Some believe that trials need only be mandated to be diverse if there is a predetermined reason to believe the drug may have a different effect on different racial groups. However, there’s a clear problem with this- no amount of research before a trial can tell you that for certain. And the cost for diversity is minimal.
Here’s the big picture- If a trial isn’t representative of the population, its not going to convey all of the information the population needs. Point blank. The problem, for the most part, has a simple solution.
Some criteria for trials exclude minorities unintentionally. But many studies have found exclusion criteria much stricter than necessary. Companies need to reevaluate criteria in order to ensure it is all essential for the study.
The FDA
So what does the FDA think of all this?
Basically, they’ve been encouraging but not enforcing companies to reevaluate their criteria.
The solution?
As patients, caregivers, and advocates, we can’t expect perfection, but we can root for progress.
It starts with physicians encouraging their patients to try a clinical trial when it is the best viable option. Right now, there is a lack of applications from people of color for many trials. This may be due to their perception of their chance of acceptance. But we can’t give up on the process. We have to fight to make it better.
- Encourage people of diverse backgrounds to apply to trials
- Minimize exclusion criteria
- Investigate participants vs. patients effected (sometimes ethnic groups are more commonly diagnosed with an illness and they’re still not the primary individuals included in trials)
- Advocate, educate and vocalize the need for change
You can read more about this issue here.
