Interviewee. Glenn Roma, PharmD, Ph.D., BCOP (Board Certified Oncology Pharmacist) is the Lead Investigational Drug Service (IDS) Pharmacist for the Baptist Clinical Research Institute and Baptist Cancer Center in Memphis, Tennessee and a preceptor for the Oncology residency and pharmacy students at Baptist Cancer Center. He received his Pharm.D. from the University of Illinois at Chicago and his Ph.D. in Biochemistry and Molecular Biology from the University of South Florida College of Medicine.
Interviewer. Tanya Verstak is a Pharm.D. candidate at the University of Tennessee in Memphis, TN.
Tanya: Tell me about your job.
Glenn: As a research pharmacist, I’m involved in all aspects of clinical research- from selecting studies, opening the studies, maintaining and operating the studies, to closeout. That begins with reviewing protocols for feasibility – determining if it’s appropriate for our patient population, if we have the facilities and resources to be able to actually perform the study as it is required per protocol. In that aspect I attend our different disease specific group meetings. We have one for breast cancer, one for lung, one for GI, and a pan disease group to cover everything else. I sit in, answer any questions that might come up, and discuss those questions from a pharmacist perspective.
We also have a feasibility meeting, which I am in charge of, and we have a clinical trials committee meeting where it’s officially voted on whether we will open the study or not.
Once we’ve gotten the go ahead that we’re going to open a trial, then begins the work to actually prepare the trial for opening. We create and maintain the pharmacy binder. We’re also setting up various documents that we use during the course of the treatment. We educate the pharmacists on any mixing, disposal, and storage requirements for the medication. Especially for treatments that have oral medications or new ingestible medications that aren’t yet commercially available, I create a patient education sheet, so the patient has the information for their treatments and can refer to that when needed.
When a new patient starts on any protocol I go to see them at that first visit to educate them on medications, the regimen they’re going to be receiving, give them that education sheet I prepared, answer any questions they have, go over how frequently they’ll come in, and what they’ll need to be doing.
On the logistics side, I’m releasing and recording information in Epic showing that we’re dispensing medication. When it comes to monitoring visits, spending time with the monitor. This is usually only applicable to industry trials. We may occasionally be audited for our cooperative trials, but those are every six months to every year. They are a lot more involved. We go over the drug inventory with the monitor and answer any questions they have about it. Upkeep of records is paramount. There is a lot more note taking and documenting than I would have expected.
Finally, during closeout we make sure that all drugs have been returned and everything is documented and accounted for. Then I turn over our information to regulatory.
Tanya: How long have you been in this position?
Glenn: I have been the investigational pharmacist for two years. I got into this position as a direct transfer from doing a residency here. I just bridged right over into the position.
At the time the position opened, it was exactly what I wanted to be doing and it worked out perfectly. Background wise, normal aspects that everyone would have in pharmacy school, but prior to pharmacy school, I also had a good bit of experience in research.
I sit on the IRB for our institution. That’s not necessarily a common thing for an IDS pharmacist, but it’s not uncommon either.
Tanya: What trends have you seen in oncology trials over the past few years?
Glenn: Some general trends are moving towards the utilization of electronic based inventory systems. There are two products out there that are web based systems for maintaining your IDS pharmacy. We’re not using them here. Instead, we decided to create our own electronic inventory system within Epic, and Epic is building that for us. We’ll see how that turns out.
In clinical trial design, one of the major interesting things I have come across in the last few years is the use of master protocols, or “umbrella trials.” So, rather than all trials simply being, “We’re going to look at this regimen plus or minus this drug in this cancer”,” we’re now looking at biomarker-driven determinations. So you’ll have an overall screening trial. A good example of this is what’s called the NCI Match trial. The patient gets enrolled with the screening trial, they get their cancer screened for many different biomarkers and then they’re allocated based on that biomarker to a particular treatment trial.
The Match Trial had about 30 arms to it. Depending on what the patient got allocated to, they would go to that arm. When you’re dealing with a trial like that, it’s kind of unique because obviously we’re not going to necessarily have a patient in every one of those arms, so we only built those out as we identify patients. So, there’s more of an urgency with getting those built at that time. Another similar trial that we are doing is called Lung-MAP. It’s a lung cancer-specific trial, again looking at biomarkers. There was a legacy version of it, but now it’s closed and this is the new one.
Protocol design has changed slightly. Each arm will have its own base version of it to give guidance. It’s really designed to make amendments easier. Rather than having to rewrite everything, you’d need to write these little pieces over time. That’s going to be interesting. It’s still nascent. They only have two arms for treatment in there as of yet.
Another trend is a major focus on the safety of a drug in patients. Oncology is unique in that even Phase 1 trials are treatment trials. So, making sure safety is up from the get-go is important. We’re constantly updating our safety reporting systems and how we’re monitoring throughout the trial, and as well as assessing efficacy. The overall monitoring has become more developed.
Tanya: What advice do you have for pharmacists who are interested in a career in clinical research?
Glenn: If you’re a student, investigate at your school. Every academic institution is going to be doing some sort of clinical trial or be affiliated with another institute that is. If you have an interest in clinical trials, get in as early as you can, even just shadowing. Keep in mind that it’s going to be slightly different than doing research as a pharmacy student. Look for the opportunities. Talk to advisers, find out what you can do to incorporate clinical trials in your training.
If you’re going to go into this position as a student, you don’t necessarily have to do a residency, but since oncology is a major venue for clinical trials it may be beneficial to get that first residency and go in that direction. For pharmacists that are already practicing and have an interest or want to change careers or directions… Basically the same advice, find out what’s going on in your institution. Most places are going to want you to have at least exposure to it; not necessarily the management aspects, but knowing what a clinical trial is. See if your institution will allow you to go through the CITI training or other training programs that they have for clinical trials programs so that you’re aware of all the background on clinical trials, all about Good Clinical Practice, the concept of informed consent, and all of that. Knowing all of that is half the battle.
If you have exposure to oncology already, you can easily transition into clinical trials. It’s not significantly different.
NCI-MATCH Trial (Molecular Analysis for Therapy Choice). NCI-MATCH, also known as MATCH, is a precision medicine cancer treatment clinical trial. In this trial, patients are assigned to receive treatment based on the genetic changes found in their tumors through genomic sequencing and other tests. https://www.cancer.gov/about-cancer/treatment/clinical-trials/nci-supported/nci-match
Lung-MAP, or the Lung Cancer Master Protocol, is a precision medicine clinical trial for people with advanced non-small cell lung cancer that has continued to grow after treatment. Lung-MAP is testing several different treatments that target genetic changes found in non-small cell lung cancer. https://www.lung-map.org/
PLEASE CITE: “Glenn Roma: A day in the life of an investigational research pharmacist.” Clinical Research Currents. May 30, 2019. https://bit.ly/2wElI3p