Are Clinical Trials Really As Safe As They Say They Are?

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Bryana: Hey guys we are here live from Los Angeles with Brandy Starks. Clinical research manager of *Science 37*. How are you?

Brandy Starks: I’m good. How are you?

Bryana: I’m good. Thank you for having us. I’m really excited because we are going to be talking about clinical trials. That is something we have heard a lot about. We have myths around. People are really nervous about it. So, I’m really happy that you’re here because you’ll be able to dispel some of those myths and get us on our way to a healthier lifestyle. Tell me a little bit more or tell us a little bit more with your experience with clinical research and what you’ve been doing in your field.

Brandy Starks: Basically I went to Dillard University. I got my bachelor’s degree in Biology. I have my Master’s in Clinical Research Administrations from Washington University. I’ve been in Clinical Research for about 10 years. I’ve worked in ophthalmology, which is around the eyes. I’ve done *evirates* heart disease, and now at science 37, I work in multiple therapeutic sessions.

Bryana: So, why is it important for people to be involved in clinical trials or even if you want to start from the beginning what is a clinical trial?

Brandy Starks: A clinical trial is sort of like a methodology where we’re trying to figure out if something works or not. Where if one option is better than another option. We do that in a way that’s the scientific method that you probably learned in like middle school or high school.

Bryana: Why is it important for people, especially black people to be involved in those?

Brandy Starks: I besides contributing knowledge to medical research communities. What’s really important is diabetes—well not diabetes, We’ll get to that later. Clinical research is a health care option. So, for me, I’m in a clinical trial myself because I get monitored very closely, or I have access to the latest treatments. For many African Americans, they don’t have that much access to health care, so it’s a free option. You could potentially get free lifesaving medications.

Bryana: Is it really free?

Brandy Starks: For the most part, yeah. It depends on the clinical trial. For the most part, clinical trials are free.

Bryana: Walk us through getting started in a clinical trial and what that looks like. If someone wanted to sign up for a clinical trial right now, how would I do that?

Brandy Starks: Well typically you would have to go to one of your doctor’s offices and they would approach you saying, ‘hey you may have this condition, there’s a clinical trial would you like some more information?’ you would then say yes I would and they would then walk you through the process. The most important thing about the starting process is that it is completely voluntary. At any moment that you say you no, you don’t want to do this anymore – even after you sign the consent form you don’t have to do it anymore. So, they’ll go through the midst, the benefits, the purpose of the clinical trial, confidentiality of your data, what they do with your health information, and then you would sign the consent form. Then you see if you pre-qualify or qualify for the clinical trial during—it’s called a screening period. What they do there is they’ll have certain test and assessments. Depending on the clinical trial and you qualify you’ll be randomized to various treatments or you may get a placebo which is a sugar pill. Or you could be randomized to seek other treatment.

Bryana: So, I know one of the major phobias for clinical trials is being treated like a lab rat. When you go into a clinical trial is it possible you can sicker? If I have a condition and we’re being split up into groups and you say one group is getting a certain treatment and another group is getting a placebo. Is it possible I can get something that’ll make me sicker? Will I get worse in the process?

Brandy Starks: Nothing is ever guaranteed. What I will say about that also is imagine this. You go to your local pharmacy you took a certain prescription. People had to go through clinical trials in order for, I that prescription to be available to you. Even after you get the prescription, that’s FDA approved it’s possible that you could get sicker from that medication. So I hope that kind of answers that question. What I would add to that is, you are closely monitored.

Lik,e let’s say you’re closely monitored and then you start to get sicker, the doctor can intervene and say ‘you know what, let’s get you out of the clinical trial or let’s get you treatment’. What’s so important about that is that will go along and help other people out in the future. Because let’s say you’re assigned to the treatment, that’s your medication and if it’s not working the FDA will be like okay this isn’t a good idea to sponsor. A pharmaceutical will say no this isn’t a good idea let’s not proceed. But, at least you contributed and helped other people.

Bryana: So, with the clinical trials how long do they last?

Brandy Starks: It could last from a week to years. So, I’m in a clinical trial right now that will at least last 10 years.

Bryana: So, what are you doing for 10 years?

Brandy Starks: A lot of it is I go once a year and I get checkups, they do blood work, they do a genetic analysis on me. All of this free by the way. I do a ecg everyday remotely. So, I always know what’s going on with my heart. It’s really data collecting. Data sciences is really important right now. The more we—especially blacks contribute to this science the more we can personalize medicine just for us.

Bryana: Traditionally we don’t purchase *** here anything and its really because of the mistrust we have against the system. Access to healthcare, different things like that. So, why is it so important for black people to get involved.

Brandy Starks: I will say this, I’m going to go back to the example where you go to a pharmacy and you get your medication. Picking up this medication, you’re going to use this medication when needed. Why not have a voice in what that looks like? Like participating in clinical trials. Your *** gets messed up and you don’t even know how it works because what we do know is that it is now primarily male Caucasians who participate in clinical trials. So, that medication and the tweaks that they’re making in the lab are guaranteed to work for them, not us.

Bryana: So, medicine culturally has different side effects if you are a white male and a black male. White woman and Black woman.

Brandy Starks: What I will say is this to me kind of goes back to the access of health care. It has to do with wealth in the community. So, it would take a lot for someone like us to have to take off from work, during business times, go to the clinic and we can’t afford to do that. So, I think that’s the reason we really don’t participate in clinical trials because of the way that its set up now you have to go to the hospital or doctor’s office while the trial is running.

We can’t do that. Who’s going to watch our kids? Who’s going to make dinner at night? There’s a lot of different considerations and I think that’s one of the reasons we don’t participate. We just don’t have time.

Bryana: is there any other way to be involved in a clinical trial without actually having to go to the hospital or is that the only way right now?

Brandy Starks: So, there’s two really great things about what we do and what are mission is. One, we absolutely think it’s important to reach out to populations that haven’t had a chance to participate because it’s only fair. I think the second greatest thing is, we do trials 24/7 pretty much.

So, what that means is that you don’t you have to go to the doctor’s office or the clinic. You can do the trial in the comfort of your own home around your schedule, but that’s before you go to work in the morning, before you go home at night, or over the weekend.

We’re available and we send everything to you. So, it makes it super convenient. We send nurses there, whoever it is we need to send there, supplies, we send them medication. So, it’s like you’re chilling at home on the couch participating in a clinical trial.

Bryana: So, are you guys finding the participants or are they finding you?

Brandy Starks: I want to say it’s a combination of both. So, you know we recruit for clinical trials just like anything other hospital or clinic would do. We also use social media a lot, so were using Facebook, we use twitter. I think we were using snapchat for a while and google. That’s pretty much how we’re trying to find our patients.

Bryana: So what do you guys do different in terms of making the community feel comfortable with participating because that’s important too.

Brandy Starks: Right, so I could say for myself I have participated and before I go into it I want to talk about how important it is that we invest in our communities. You know just go in there to get something to get participants and bring them back and say you know what you’re done with this study.

We’re done with you. It’s not like that. So, I’ve helped with some education. I have spoken to church about clinical trials. Helping to build community guidance. In addition to that, we do go to several different events like to cater to certain disease states. But, we’re still a baby company. We’ve only been around like 4 years so we have a lot of plans in the future to really do a grasp route nationwide effort and really engage with the community, and educate them.

Bryana: I love that you said that you guys go out and do more than just recruit because that’s a huge reason why there’s such a mistrust, but when you go and your there before something happens and after something happens I feel comfortable with this person.

Brandy Starks: I myself have to do a better job. I call my mom and I call my mother-in-law, and I was like hey guys would you ever think about participating in a clinical trial. And they were like I never really thought about it. Which means I haven’t been doing a job educating them. This could be a legitimate option for you.

Bryana: I know you guys do a lot of work with diabetes. Why is diabetes research so important?

Brandy Starks: We already know that diabetes unfortunately effects African Americans. We all know that. And on a personal note, I have lost so many people I love diabetes. I’m trying not to get emotional about it, but its hurtful and that they’re creating drugs and medications that are not for us.

I think that we have to participate and we want that that voice. That is how we speak and tell people what it is that we want and how you have to pay attention this by participating in any clinical trials. Like I said if we’re going to continue to go to the pharmacies, and pick up medication—no matter how much we may not like how high drug prices are. But as long as were going to go to the pharmacy we need to have a voice in that.

Bryana: So, with the diabetes, clinical trials is it something you could speak more specifically to? What do those look like? In terms of like if I was at home, what would be some of the things I would be doing to participate?

Brandy Starks: Generally, about diabetes clinical trials. You probably have a physical exam, a EKG—it really all depends. You’re going to have your sugar tested frequently. You’ll probably get medication sent to your home. This is the *Science 37* model you would have access to your study team 24/7. You would have access to your study doctor. You would be very closely monitored. Monitored for like a *adperson* that is bad things that could happen. That is pretty much in any clinical trial.

Bryana: I know that for the diabetes clinical trials, do those have a certain amount of time that they run or is still arranged between a week and 10 years.

Brandy Starks: There are a few components. Let’s say there’s a fresh new drug out there’s not FDA approved yet. So, we’re still looking to make sure it’s safe, it’s effective. in order to show its effective for the FDA, let’s say we need 1,200 people well that study won’t end until we have 1,200 people. There are a few factors, sometimes there’s time factors. Like ok, we can only run this study for 3 years and then that’s it. Or, we need 5,000 people, which in these larger trials you will need 10’s of thousands of people.

One thing I wanted to just sort of hit on when it comes to clinical trials is even when you pick up that prescription at the pharmacy, the research does not end. So, even drugs that have been on the market for years and available to us for years and the FDA is looking at those drugs. When a drug is freshly presented to the FDA they may require that we do some long term review of that drugs because let’s say testing only requires x amount of years, but what does it look like 15 years from now? What does it do to our bodies?

Bryana: I want to follow up on that. I forgot to tell you guys we are answering your questions at the end. If you do have any questions, leave them in the comment section. We will take them. If you guys have them then leave them in the comment section while we’re live. I want to know, going back to the drugs because that’s really important. So, two questions for that. Is one, why would it be important for us to—like something like albuterol for asthma. If we’ve been taking that since it came out and its working why is important for us to go back and say this is the best option.

Brandy Starks: You mean like when introducing better drugs? Or better treatment options?

Bryana: Yes.

Brandy Starks: Well, what if with albuterol there were side effects that we just don’t really like and there’s another company that comes in and says hey we can top that have less of those side effects and it may work better in this sort of way. Then you would essentially start a clinical trial on that.

Bryana: So, once the clinical trial is done, would they take albuterol off the market?

Brandy Starks: No, it would stay because we would need or the company would need to prove that it’s at least just as good or better than what’s currently available.

Bryana: If it’s not as good or better than it’ll be taken off the market.

Brandy Starks: It depends, but I would think no.

Bryana: Another question I had about clinical trials because I think that this is a part of the reason why we’re like I’m not going to join that. What happens before a clinical trial is even made an option? Like how is it tested before to make sure it’s safe?

Brandy Starks: So, there’s a couple of avenues that it could go. Let’s say you’re—let’s say there’s a drug that’s already available and people can take it. They may tweak it a little bit and then run through the trials to get then get approval that way. If it’s just brand new, it all starts in the lab.

So, you’ve got scientist working in the lab, you get to the part where you’re testing it on animals and seeing how that works. Then you’re testing it in most likely males for safety reasons. We don’t do females because of their reproductive issues, you just never know. So, we test it scientifically on males. Then it moves on to the population without the disease it just depends on the study. So, let’s say without the disease you can get more safety data. Then your pool of participants grows, and grows, and grows. Then it essentially goes through 3 phases.

I won’t go into the phases because it’s too complicated. That is essentially how it works it is really the scientific method of trial and error. Let’s say you’re hesitant, you don’t want to be guinea pig. You want to participate, but you don’t want to feel like a guinea pig. I would say participate in a trial that is looking at two FDA approved drugs. That way you may feel better about it, you can get your toes wet a little bit. That way you know at least the FDA has looked at it, they’ve looked at the safety data, they made sure it was effective. I want to help people out, let me try that method.

Bryana: For clinical trials are there usually—I know the health care aspect is no cost, low cost. Is there usually any compensation for participating?

Brandy Starks: Most studies—most clinical trials involve some sort of intervention meaning we are doing something to you. Whether it’s a device or some sort of drug there is compensation for your time, for coming—sometimes having to leave work. Although it’s tricky in a way, you don’t want to be cohesive and pay people too much. Typically to cover like gas cost.

Bryana: I think I’ve done a few at our school in college and I was like well this is going to pay for this. I remember there was a group of people by a body scan. I was like in this machine playing a video game. They were like watching my brain and other brain functions. It was totally not invasive. I didn’t have to get undressed or anything to go into a machine. I put my jeans on and I laid there for about 30 minutes or so and then I went home. But know they had some—I remember the list now like its coming back to me. They had some where they watched you sleep.

Brandy Starks: Yes, the sleep study, but isn’t it fair to pay for your time because you could be doing something else, so some things are worth something.

Bryana: Now that it hit me I’m just like wait, but it’s true because I’ve had those experiences. I would be more likely to say ok let me look into this and see if I’m interested. As opposed to not even being interested of the idea.

Brandy Starks: On a personal note I have a chronic condition that when it flares up—I have fibromyalgia—when it flares up it is debilitating. I can’t walk, everything hurts, I cry all the time and I’ve been desperately looking for a clinical trial and I can’t find one because there is no one near me. So, I can’t do it. Not only do I want something for myself and it’s not guaranteed that it’ll work, but you never know. So, it’s not just for myself, but I want to help other people who have that conditioned. But, I can’t so I’m stuck and I think for me that’s just another plug *science 37* is so great because it wouldn’t matter where I lived. We have participants from all over the United States.

Bryana: That’s a good point too that you mentioned that there is nothing right now that is working for you. With conditions like Cancer, there is no cure right now, so being in a clinical trial could be the cure.

Brandy Starks: You just never know, but all these therapies that we have available to us today is, unless it was your grandfather from like 80 years ago, they’ve gone through a clinical trial. But, if you want medications for us then you have to participate. We have to participate. If we want other health care options, just participate.

Bryana: Okay, I think we have a couple questions…
Question from our audience *Calvin Jackson* wants to find out what trials are available for us in this area?

Brandy Starks: That is a very good question. I think your best source would be clinicaltrials.gov. We’re required—every single hospital, clinic in the nation is required to post those trials on clinicaltrials.gov. That would be one of the easiest ways.

Bryana: Okay, if you guys have any more questions or comments please leave them and we will get back to you. We will send you a message after the video is sent. But, Brandy I just want to say thank you so much.

Brandy Starks: Yes, this has been fantastic. I would love to answer anymore questions. My email is brandy@science37.com. Please feel free to send me your questions.

Bryana: So we’ll write it—type it for you guys just in case in the comments. We’ll also post the clinical trials website and then the science 37 website.

Brandy Starks: Awesome

Bryana: Awesome. Thank you guys. Have a good weekend. Have a good Memorial weekend. Bye!

Source: Black Doctor – Healthy Living

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