You may be curious about clinical trials but find the landscape confusing. So consider this your starting point. We have taken some key insight from one of our webinars featuring Dr. Ramona Burress, then Associate Director of Diversity and Inclusion at Janssen Pharmaceuticals. You can watch the full video below:
What Are Clinical Trials?
So clinical trials and research are just experiments, but again, designed in such a way that they help investigators and scientists learn more about diseases, medicines, and treatments. It’s conducted by doctors and other healthcare providers, including nurses and physician assistants; we’re looking at nurse practitioners and PhDs. You can see a lot of those different roles as investigators and researchers. What it means to be an investigator in research is that you are responsible for the research being conducted at your site. Now, you may be part of research where there are potentially a hundred sites across the globe, and you’re one site, but as an investigator, you are in charge of making sure that everything that happens in that research setting is ethical, that there is no harm done to the patient. And that, again, the conclusions that are pulled from that research are scientifically sound and statistically significant. So it’s a huge responsibility because it means a lot of protocol management, making sure your staff is trained, but again, making sure that we’re having authentic touch points with patients so that we can learn more about them and making sure they’re the right fit for the research that we’re conducting.
What kind of questions can clinical trials answer?
If I’m looking at it from a medication standpoint, it’s going to tell me if the medication is safe. Does it work for the health condition that we’re creating it for? How is it metabolized? And when we see metabolize, I know that sounds like a crazy big word, but think about how our body processes things. I can have a drug that’s metabolized by the liver, and then I can have one that’s metabolized elsewhere in the body. If I look at how it is eliminated, I need to know what type of pressure it puts on the kidneys. Maybe if I’m standing up this trial, I want someone with healthy kidneys, and maybe I’m looking at creatine clearance cut-off as part of my protocol and design of the study.
So all that’s important and all that is kind of what we learned in this research setting. And then two, if I’m standing up a drug, let’s say hypothetically for cholesterol, and I already know that there are other medications on the market that doctors are prescribing that clinicians are prescribing to their patients to treat cholesterol, I want to think about, okay, well where does my potential medication fit in this role of therapy? Am I saying that my medication may be better than what’s on the market? Or am I thinking, Hey, it may be for someone who has research and wants to learn more about the research and healthcare itself have a familial connection to cholesterol, a genetic component of cholesterol, and sound for us to make clinical decisions researcher wants to learn more about the condition?. So, these are all questions we seek to answer as we set up different clinical trials specific to medications.
How do we know clinical trials are safe?
We know that in our communities, our Black and Brown communities, research and healthcare itself have a complicated history. We know about Tuskegee; we know about Puerto Rican and birth control appeal trials where there was harm and grievances done to people within our community. But I’m happy to say that there are, again, those measures in place from a safety perspective that ensure we protect the rights of patients and participants in studies where we didn’t have that before. You have people like me who are members of the community that sit in these RD spaces where decisions are made so we can too circumvent and say, Hey, no, let’s make sure we do our due diligence as a sponsor of research since we don’t have any harm done to patients. So yeah, there’s been a shift from what we know to have occurred in the past because it really wasn’t that long ago. We’re really going to be honest about it. There have been some within our lifetime, some failures and research. But again, holistically, we’re doing better. There are more checks and balances. We have to report to an IRB review board that looks at our study procedures. So, there are more formal processes in place to protect patients’ rights.
Where would I start if I was interested in participating in a trial?
But for anyone interested in being part of research, the first step is to start with your doctor to see if that’s even a viable option. I will go through some of the stages of research because not all clinical research is meant to be an option of last resort. So often, I think there’s a misunderstanding that, hey, I’m dying of this disease, and there’s no medication to treat it.
So, all I have is clinical trials. In some spaces, that may be true, but in many spaces, when I look at the drugs that are being developed by scientists and by companies such as mine, I see that it’s very much so preventative medicine, precision medicine, where we’re going after certain biomarkers and certain genetic factors, and we’re coming up with therapies that are curative and preventative. So, it’s shifted how clinical trials are and why it’s important for us to be in these spaces.
