Diversity in Clinical Trials for Biosimilars

Amanda Forys, MSPH: I’d like to focus a little bit now on the future of the biosimilars market, and also a little bit about the clinical trial process. Let’s talk first about clinical trials.

During the FDA’s Oncologic Drugs Advisory Committee, when they were addressing the approval of Mvasi, some voting members raised concerns about the clinical trial that was submitted. It was a predominantly white, exclusively male population. Do you think that diversity in clinical trials is important?

Christy M. Gamble, JD, DrPH, MPH: Oh, it is key, absolutely key. There are certain genetic differences, biologic differences, social differences, social environment differences that have to be taken into consideration when it comes to clinical trials. We always say that you have to incorporate the lived experiences of all individuals to ensure that you are creating therapies and vaccines that are effective in all patient populations. When you only test on 1 particular group of individuals, like we’ve been seeing white males, you do quite a disservice to the rest of the population.

We’re seeing women, and more so racial and ethnic minorities, being left out of a lot of these trials. When it comes to testing the effectiveness of these drugs in those populations, we’re seeing that there are some issues. When you don’t take into consideration the general population, you’re creating drugs that only work in an exclusive population who had the privilege of being a part of a clinical trial.

We’re always advocating for more diversity, [and] oversampling of people of color, women, in trials that make sure that everyone has access to these innovative therapies.

Amanda Forys, MSPH: That’s an interesting thought because we see a lot of data coming out from [the Institute for Clinical and Economic Review, ICER] for example, looking at cost-effectiveness studies. I have a lot of discussions with my colleagues about this, and I think the whole concept of cost-effectiveness is great to explore and discuss, as I think value and cost are very important components of healthcare.

But one of the problems I have with it is that we’re always looking at it based on a clinical trial population. If payers are going to start making these decisions about their patients, or if Medicare were to ever start implementing formularies based on these type of reviews, what are you actually seeing in the real world that you can attribute to patient outcomes based on therapies that they use? Are they truly cost-effective?

Here you are looking at a set time period for a clinical trial, you have a set group that have been selected and met very specific criteria. We both know the real world doesn’t work that way.

I think that’s a good, fair warning to everybody to think about not just how you’re designing a formulary, what products you’re bringing to market, [and] how you are effectively covering them for patients, but also, are you making sure that you’re appropriately representing what each of your groups needs through these clinical tests and data that you’re moving through, to make sure that they’re getting coverage and that evidence that you need?

Christy M. Gamble, JD, DrPH, MPH: Yes, and you raise a good point, we’re looking at traditional medicine, traditional drugs, right? You’re looking at the US Preventative Services Task Force, creating the list of recommendations for drugs, or therapies that should be covered. Insurers look to those recommendations.

A lot of those recommendations are based off of clinical trials that were conducted and included primarily white men. When we look at the recommendations, we say, “This doesn’t work in our population.” Black women and girls have different genetic expression. When they go to their provider and they ask for a particular drug, it’s not covered. That is an issue, that’s a huge concern for us and we don’t want that same mistake to travel over to these innovative therapies where certain therapies are covered and others are not, and they’re not effective in all populations.

Amanda Forys, MSPH: Even just adherence. You were talking about the low-income population, [what if] they had to take a therapy 4 days a week? Are you going to see a person of low-income who can’t get to where they need to go and can’t pay for the ride there, are they getting that drug? You have that whole issue in the real world as well.

Christy M. Gamble, JD, DrPH, MPH: Absolutely.