HCDM 30 | Understanding Seizures And Brain

 

With terms like vaccine trials and research currently being floated and discussed in the media right now, it makes you wonder how does the research get done? Dr. Richard Marn’s guest for today’s episode is Onome Eka, a Clinical Research Coordinator for the Epilepsy Program of the Department of Neurology at Mount Sinai Health System. Onome discusses how they’re doing research studies to understand seizures and the brain at Mount Sinai. She also explains the importance of their role in making sure the studies’ information and the coordination of such research are done in the right and proper way, especially as it applies to clinical research and healthcare.

Listen to the podcast here:

Deconstructing Seizures And The Brain With Clinical Research Coordinator, Epilepsy – Onome Eka

Terms like vaccine trials and research are being floated and discussed in the media. It makes you wonder how does research gets done? How do these trials and research trials get completed? We’re going to talk with someone that works intimately with those studies, not vaccine studies necessarily, but research studies. We’re going to learn how their role is instrumental in making sure the information in the studies and the coordination of such research is done in the right and proper way, especially as it applies to clinical research and healthcare.

My guest is a Clinical Research Coordinator. Her name is Onome Eka. She was born and raised in Nigeria. She received her Nigerian Medical degree soon after secondary school and worked as a physician in Nigeria for a couple of years. As a medical officer, she became intrigued with public health. She applied and got into NYU’s Master of Public Health Program. She’s been active in several aspects of the research process such as being part of the Institutional Review Board or IRB. For a few years, she has been a Clinical Research Coordinator for the Mount Sinai Health System, Department of Neurology, specifically the Epilepsy Program, which we’re going to talk about. This interview is wonderful. It’s rich with details on how she helps research achieve the proper results and how important details are. In this interview, you’re going to see how much time she does spend with patients and how important that is. Let’s dive into this interview and get to meet Dr. Onome Eka.

Onome, welcome. I’m excited that you’re here. I want to learn more about what you’re doing. Thanks for coming on board.

Thanks for having me

You are a clinical research coordinator too. I know we talked about that before, but can you tell me what your profession does? What type of patients are you taking care of? How exactly do you help them?

As a clinical research coordinator, the main thing you do is oversee the conduction of clinical research, which involves both technical and nonclinical trials. You make sure that everything is done according to federal regulations, ethics are followed, and patients are happy from the design, in some cases, to the activities of the study. Follow the protocol of the day-to-day operations to make sure that everything comes together perfectly and seamlessly. That’s what the coordinator does.

When you're talking to people about your study, make sure you are able to explain to them in the manner in which they understand. Click To Tweet

You’re doing clinical and basic research. What kind of studies are you studying? What kind of patients are you dealing with?

I mainly work with epilepsy patients. I work in an adult epilepsy division. Mainly adults, although we do have some clinical studies where we work with the pediatric arm as well. I do have some pediatric cases as well, but mainly adult epilepsy patients. That’s my target population.

Could you give us an idea of some of the research that you are doing with these patients?

We have some clinical trials. Clinical trials are usually like new drugs or new medical devices that’s interventional. You’re using them to things that have not been approved by the FDA, which is the Food and Drug Administration, an agency that oversees that every drug that comes into the market is safe and it does what it’s meant to do.

How long is your involvement with one study? Is it done in a month, a year, a couple of years?

It depends on the study. We have some research studies that are observational. You could have a retrospective study, which is a study that is looking at data that has been collected previously. For such studies, you’re looking at patients’ charts. You’re pulling out the data that was collected. Maybe you’re looking at patients with epilepsy that had this surgical procedure versus the other one. You want to see what are the outcomes. You’re going back in time. Those studies might not take a long time because the data is already there. You’re using what we call secondary data. That’s data that was collected for clinical purposes, not necessarily research, but now you have an idea and you want to look at that data. We also have the clinical trials where it’s a new drug that you think by coming to the market change things for people with seizures. Those are people that have epilepsy because epilepsy is when you have recurrent unprovoked seizures.

You’re only doing clinical research?

Yes, I only do clinical research, which is a mixture of observational studies. I have retrospective studies. I have even prospective studies. You’re following patients in real-time, but not necessarily clinical trials. You’re not giving them drugs that have not been approved or you’re not putting a device. We are not intervening in anything. We have clinical trials, which are randomized in a strict setting because you are giving medication or a chemical compound that we’re still testing and observing. We don’t know how safe it is or how efficacious it is yet. It could also be a medical device as well. Maybe a chip that if you put in the brain might be able to predict or stop seizures. Those are different. It’s controlled compared to an observational study where maybe you’re looking at patients that have epilepsy. You’re maybe taking blood or looking at the risk of depression or behavioral disorders in them. You can’t see that yet. The risk in them is different.

To do this research, you’re working closely with a bunch of team members and several of them include other researchers and physicians. Is that true?

Yes. I work with that academic institution. For every research at most academic institutions, the principal investigator, which is the director or the head of the study team is usually an MD. Some of them can be MDs and PhDs but usually an MD. You also have sub-investigators that can be MDs as well. Some can be also patient providers and nurse practitioners. You could also have a research nurse. You could have a data specialist. There are also people that their role in the research study is where you collect all this patient’s data and they’re going to analyze. You can have bio staff and statisticians. You can have epidemiologists.

You’re working with them on a regular basis?

Yes. We do work with them as well. In some cases, apart from the primary research team, you also have other coordinators. There are some studies where I work with the pediatric division. I also have to do liaison work with the pediatric clinical research coordinators as well. It also depends on different kinds of studies. For studies where you have inpatient monitoring, meaning you’re bringing patients into the hospital, you’re keeping them to maybe administer this new drug and you want to monitor them. You might also have to recruit nurses that will sit there to monitor and do some other procedures. It also depends on what the protocol of that particular study calls for. You can bring in more people in some studies, and in some studies, you need fewer team members.

HCDM 30 | Understanding Seizures And Brain

Understanding Seizures And Brain: The FDA is basically the agency that makes sure that every drug that comes into the market is safe and does what it’s meant to do.

 

Even though the physician or MD or primary clinician spearheads this study, you’re in charge of coordinating all of it, making sure all the pieces come together, all the people come together and get the patients on board. You’re doing research so you’re on the cutting edge of what’s the latest information and testing that information out there on patients. What’s your interaction like with patients?

For most of my studies, I have a close interaction with patients. If you’re going to go into clinical research, you have to be prepared to interact with patients. You need to have good communication skills. First of all, you need to know your study in and out. The one thing I’m always careful about and I stress a lot is being able to make sure that when you’re recruiting people or talking to people about your study, you are able to explain to them in a manner in which they understand, which is why we have a document called an informed consent document. This is a pamphlet of several pages.

It has several sections that tell the patient everything he or she needs to know about the study, why the study is being done and the benefits. You must also tell the patients about the risk, how long the patient would have to commit to participating in the study so that you’re fully aware of the time commitment. If it’s going to cost you because there are studies that you’re traveling to the hospital and back, you’re not being compensated for your transports then you’re losing money. You have to make sure the patient knows. There are some studies that there might be some compensation. You have to make sure that the patient is aware that, “Maybe we’ll pay you this.”

You also have to find the balance to make sure that money doesn’t become the incentive for people to participate in research because it might become predatory where people that are economically disadvantaged find that they are persuaded. It gives them better judgment to participate in a research study because of the economic benefits. You have to make sure that as a coordinator, when you’re sitting down with your PI, the Principal Investigator, which is the lead medical doctor. They are also co-investigators or sub-investigator. They are also medical doctors in the same study. You have to make sure that there’s a balance as well. An important thing is to make sure that before the patient signs the document, it is written in a language that is suitable for an eighth-grader. The main thing is the patient must be able to comprehend because it’s one thing to tell someone something, give them a document, and get them to sign it, and the patient doesn’t fully understand what it is they are signing up for.

Also, making them know that at any time, they can walk away. It is allowed because it is voluntary. You are under no obligation to participate. At times where you have the principal investigator or the doctor conducting the research might also be the doctor caring for that patient. You want the patient to know that even if you choose not to participate, it’s not going to affect your regular clinical care, so you don’t feel pressured. Those are some of the things.

It’s a lot of things you’ve got to keep in mind. When you’re trying to recruit a patient into a study that you’re doing, you are the person that they bring in to talk to the patient about the details of the study and tell them why you want them in this study. That’s your responsibility. You have to know the study well because they could have a whole bunch of questions and you have to be able to answer them.

One of the things I try not to do is cold call a patient. When you screen and you feel like this patient might be eligible for this study, I don’t like to call. Most times, I will go to the patient’s epilepsy doctor and discuss with the doctor, and also my principal investigator, the lead physician on the study. We’ll tell the doctor like, “This patient is a good candidate for this study. Do you think your patient will benefit?” If the doctor agrees, the doctor can give the patient a call, “There’s this research study, are you interested?” When they say they’re interested, then I can follow-up and call, send them the consent form, give them time to review it, and then schedule another phone call or an in-person visit where I can answer all their questions.

As your job title, which is a Clinical Research Coordinator, there is a lot of coordination that you are doing to make sure you get the right patients for the right study. Do you spend a lot of time with patients talking about this study? Is it just one phone call and that’s it?

It depends. There are some patients that are ready and interested, or it’s something that they need. I’ve had a case where a patient was supposed to come into the EMU, which is the Epilepsy Monitoring Unit. Maybe the insurance company is not approving and then this study has maybe an EMU portion. You’re able to come in for clinical care, but you’re able to still capture your seizures for your routine clinical care without you having to pay. It’s almost a win-win. Patients like that may be easier to convince. Maybe they’ve spoken with their doctor or they’ve already agreed. You’re going through the semantics of consenting them.

If you're going into clinical research, you have to be prepared to interact with patients and have very good communication skills. Click To Tweet

There are other patients where they need more time. You have to follow-up 2 to 3 times. I’ve had patients that would have scheduled the first follow-up. I will spend an hour going through all the paths. They’ll still be like, “We want to discuss it with family, and then get back to you.” That mainly happens. It usually takes longer in cases where it’s a pediatric patient and parents. Maybe one parent wants to speak with the other. You want to make sure because this is a child, or in cases where you have incapacitated adults, those are cognitively-impaired adults. You need a legally-authorized representative. Maybe the member of the family has been designated to be the person’s signature for any medical procedure. Before you enroll someone that is incapacitated in a clinical research study, you might want to discuss longer with your family members. As opposed to when the adults are fully capacitated and I’m making the decision about myself, it’s easier for me to take a quicker decision.

What I’m trying to understand is that you do spend a lot of time communicating with patients in your job. That’s part of your role, and spelling things out for them in simple terms while trying to coordinate all the other pieces with the clinicians, the timing, and how they’re going to get the therapy if it’s involving therapy. Is that about right that there are a lot of discussions with patients? It’s not hiding behind a computer and doing computer work.

Apart from recruiting patients into the study, even when they’re in the study, there are studies where I have to administer weekly behavioral assessments to patients. I have a study where I call eligible patients every day. I have to call three and it’s usually an hour. These are people that I have been following up with for 1 or 2 years. It’s almost become a friendship because they’re expecting your call. Sometimes I’m unable to call and they will call me and be like, “Onome, aren’t we supposed to speak?” They are almost like friends in your head, but you still have to remember that they’re still your patients.

You get to know them quite closely.

Epilepsy is a chronic medical condition. It has a lot of stigmas. Here it’s better, but in other parts of the world, there are a lot of stigmas associated with epilepsy. It’s also debilitating. It takes a lot away from people. It’s something that is unpredictable. It can happen suddenly. You were fine, then you had one seizure, and then your whole life changed. Especially for studies where you’re screened for depression and anxiety, people are able to talk to you. People that you feel you understand may share their struggles and pain, but they might not feel comfortable communicating with their family members that they feel might be worried about them. There’s patient interaction. A good relationship is needed. You build relationships.

You’re doing the research by getting this data and getting the right patients. What is your typical day like from start to finish?

It can’t be unexpected. It’s not like one day you go in and you do the same thing because you have multiple studies at the same time. Each study requires something different. I would say the first thing, you wake up in the morning and you see a slew of emails, maybe the sponsor for this particular clinical trial. Most clinical trials come from the pharmaceutical company, which we call the sponsor. Those are industry-funded studies. They have clinical research associate to monitor that’s assigned to different study sites, which is where we work, the different medical institutions where the research is being conducted. The monitor might ask you for a delegation log, “We need your PI, your head researcher, scientists. We need this, we need that.”

You need to put in this data. They might be following up all the study. We need to recruit more patients and different things. They’re asking you for things. You could also get emails from patients asking questions as well. You also have things within the institution as well that you have to do. For you to conduct research, you have to submit your research to an IRB, which is an Institutional Review Board, which is usually a group of people or a board of people. They must have a science background and a non-science background like a mix of people.

You’re handling a lot of communications, whether it’s email, phone calls between the medical people, nonmedical people, the patients themselves. You’re the entry point for these studies to get that information done correctly and to the right people. In terms of your day, you’re handling this. What is your day like? Are you just dealing with emails and phone calls?

You might also go into meetings. In my institution, we have a clinical research meeting. You might go into a meeting with researchers that have an idea. They’re brainstorming about a new study you’re sitting in, chipping in, and then you might have to go out, and then write the protocol based on what they’ve said.

Do you help write the protocol sometimes?

Yes. You could also have days where you have patient visits. For the clinical studies now, you have scheduled visits where the patient comes in, and a set of activities must be carried out on that patient. If I’m expecting the patient to come in, I would have already booked for a clinical research unit room that a patient will be in. Making sure that the head researcher, which is the PI, their schedule is clarified to make sure that he can call me because everything you do you have to sign off and they have to see as well. After the emails, if I have a patient coming in, I have to go meet and consent the patient. If it’s a follow-up visit, discuss it with the patient. If it’s a study that requires blood draws, I have to draw the blood. I had to get a phlebotomy certificate. I had prior experience in that. Everything from drawing blood, doing EKGs if necessary, assessing the patient. You also have to process this blood and ship it as well.

You’re doing a lot of the grunt work as well, getting your hands dirty, but also involved in meetings and coordination of information between the right people.

You might also have to submit things to the IRB. Maybe you have pending studies that are on review. They might send it back to you with comments and things that you need to follow-up on that as well.

When does your day end?

On a good day, it ends at 5:00. A lot of days like pre-COVID when we had a lot of research and things like that, if a patient is coming in at 8:00 or 8:30, that’s the most convenient time for the patient. We do try to work around the patient’s schedule. I have to go in early. I can’t say, “I work from 9:00 to 5:00.” You have to be flexible. There are days when I had an inpatient study where the patients will come in and we’re waiting for them to have the seizure to administer medication. The patient was there throughout the weekend and have a seizure on a Friday afternoon. I had to go in on Friday. I had to go in on Sunday as well. Sometimes it depends. There are studies where they will call me at 2:00 AM where I have to speak to the nurse at the bedside to tell them this is what to do. Sometimes it’s 9:00 to 5:00. Depending on if you have something active, they have to work around the clock.

HCDM 30 | Understanding Seizures And Brain

Understanding Seizures And Brain: Observational studies follow patients in real time, but not necessarily clinical trials because we are not intervening in anything.

 

What is the most rewarding part of your job?

The most rewarding part of my job is seeing improvement in patients. Seeing people become better, the patient interactions. I have a particular study where I have a patient that I have followed for more than a year. In this study, there’s a particular device they put into the brain to stop or reduce the number of seizures. I call the patient weekly to assess his mood and different things. This was someone that was having drug-resistant epilepsy. For you to qualify to get that device, you have to have epilepsy that has been controlled with two or more anti-seizure meds. We’re talking of someone who at the beginning of your journey, depression was seen every day, multiple seizures in a week. Now the person is almost seizure-free and barely having any seizures. You can see the change in the patient’s outlook on life. Maybe someone that couldn’t even work before, the person is able to transition back to work. They have autonomy over their life. That’s fulfilling for me.

That’s awesome to be a part of that and help play a role in that. Is there a least favorite part of your job that you can tell us about?

I would say the paperwork. Some days, it feels like you’re moving paperwork, but it’s a good balance. Sometimes it can be maybe you’re printing out things. The monitor is like, “We need you.” Maybe you put something on there like the format of the date should be the day before the month, little things that you have to edit something and getting everyone to sign, which can be difficult. Those are the days that can be a little frustrating, the massive amount of paperwork.

What are some of the misconceptions people have about your career as a clinical research coordinator?

The main misconception people have is that you have to have a strong clinical background. It is a plus but it is not necessarily a requirement. There are still ways that you can get into clinical research without having a strong clinical background. It is something you can build along the way. There are different entries and different job functions you can do within the clinical research space that may allow you to still get your job done without having a strong clinical experience prior to starting the job.

What type of people do you think the best function and do well in this type of career and profession?

The main thing is you have to be detail-oriented. Attention to detail, the little thing especially for drug trials. You could conduct a drug trial and it has closed. When you worked on the drug trial it’s in phase or something. It’s getting to the point where it might be approved by the FDA, which is the Food and Drug Administration Agency. They might randomly pick your sites to come and review what you did. They are looking at your document. Something as the informed consent form and the patient that participated did not sign it like, do you understand before you started conducting research activities? Every paperwork, you must be detail-oriented, attention to detail. You have to be overly meticulous. You have to be self-motivated because a lot of times, I set my schedule. There might not be a lot of oversight because the MDs are running the clinics. You’re doing a lot of things. You have to have foresight. You can predict like this might be a problem in the future before they arrive. Prepping and covering everything to make sure that nothing arises in the future.

The whole study could be messed up or the information is not going to be valid.

Another thing that I would say is integrity because I believe in data integrity, to make sure that the data you’re collecting and what you’re entering into the database is correct. You don’t want to falsify data that will be analyzed and give a result that is not reliable later in the future. Integrity and then communication is important. You have to be able to communicate with people effectively from the patient to the sponsors and the medical doctors. You have to be able to tell them if you see something that might not be right. Although you’re working for them and underneath them, you have to be able to say, “This is not right.” You should be able to speak up when you see something, and be a good patient advocate.

It’s lost in conversation about with research that sometimes it’s not sexy. It’s not all in bold letters and italics. Sometimes the work is focusing on details, and these details add up to results. If the details aren’t there, those results are not useful or valid. The simple things where research is done in the trenches.

In the movies you see all the rush to find the cure to this disease. It looks sexy but it’s hard work. From recruiting the patients to following up, to getting things done, it’s a slow process. It’s not fast.

This career and profession, what do you think is the outlook for it? Is it here to stay?

Clinical research is here to stay. We can see that with the world that we live in. As the world becomes more globalized, you can see that infectious diseases seem to be contained in developing countries. Here, you can see that when we travel and everything, we have an exchange. We keep seeing that even previously known diseases are undergoing genetic mutation. They’re coming back in new forms. There’s always the need to find cutting edge and new therapies for new diseases and evolving diseases. Diseases that have existed, but they changed their modality and their pattern. Clinical research is here to stay. Innovation is key in the world. The world is changing so you got to adapt to the change.

The most rewarding part of the job is seeing improvement in patients and seeing people become better. Click To Tweet

I want to shift gears here. This does not need long answers, as long or as short as you like. How many hours of sleep do you need?

You need eight hours of sleep, but I never get it.

How many do you need?

If I sleep for 5 to 6 hours, I’m good.

Climb a mountain or jump from a plane?

Climb a mountain.

What’s something you could eat for a week straight?

I’m a rice lover. I’m addicted to rice.

Any type of rice?

Fried rice, rice in any form. I can eat all day, every day.

How do you hope you’re described by people when you’re not around?

I hope they describe me as someone that has integrity. Someone that would always speak the truth, not forcefully in people’s faces, but I say what I knew and I knew what I see. That’s how I would hope to be described.

On a scale of 1 to 10, how strict were your parents?

When I was growing up, my parents were eight. In retrospect for Nigerian parents, my parents were liberal. At six, I could talk to my parents. I’ve never been scared to speak my mind to my parents.

What’s the most beautiful place that you’ve ever been to?

I will still say Dubai.

I’ve always wanted to check out that seven-star hotel.

The Burj Khalifa, I’ve seen it from afar but I’ve never gone into that.

Finally, can you say something about yourself that most people at your workplace would not know about you?

Most people don’t know that I have a quirky sense of humor.

You’re a good laugher. Thank you for laughing about my quirky and weird jokes.

Thanks for having me.

Where can readers go to reach you and learn more about you?

You can go to LinkedIn. That’s the only social media platform I’m on. Type in a search for Onome Eka and you’ll find me. Feel free to reach out to me.

HCDM 30 | Understanding Seizures And Brain

Understanding Seizures And Brain: The main misconception people have is that you have to have a very strong clinical background. It’s a plus, but it is not necessarily a requirement.

 

Dr. Eka, thank you for coming on board. I had a great time and learned a lot about how you are doing the hard work to get these studies out, doing the research, and can help people out now and in the future.

Thank you, Dr. Marn, for having me. You were a lovely interviewer. It felt natural.

Those are kind words. Thank you.

You’re welcome.

That’s our show, everybody. Thanks for tuning in. To learn more about our guest or other past guests, check out my website, HealthCareersWithDrMarn.com or HCWithDrMarn.com. If you like the show, please go to my website, add your name and email to my email list. That way you can get the latest announcements and news as they arise. You can also find me on Instagram, @DrRichardMarn. Thank you and I’ll catch you in the next episode.

 Important Links:

About Onome Eka

HCDM 30 | Understanding Seizures And Brain

Clinical Research Coordinator II, Epilepsy Program, Department of Neurology at Mount Sinai Health System