Matthew Geriak, Pharm.D. is an Investigational Research Pharmacist at an institution in San Diego, California, and an Adjunct Clinical Associate Professor at Touro University California. He has 22 years of experience in hospital pharmacy and 10 years’ experience as an Investigational Research Pharmacist. He received his Pharm.D. from the University of Southern California (USC).
Matthew is interviewed by Tanya Verstak, Pharm.D. candidate at the University of Tennessee in Memphis, Tennessee and publications intern at Clinical Research Currents. She has an M.S. in Clinical Research Organization and Management and is pursuing a career in clinical development and pharmacovigilance.
Tanya: Tell me about your job.
Matthew: I am an Investigational Research Pharmacist System-wide Lead for an institution in San Diego, CA. Ninety-five percent of our job is working on industry-funded studies. Pharmaceutical companies come to our site and ask, “Would you be willing to manage this study at your site?” It’s usually a global study that’s being done at hundreds of different sites across the country, across the world for that matter. Bristol-Myers Squibb or Pfizer, Johnson and Johnson, those kind of big pharma companies and smaller pharmaceutical companies would first assess our site for feasibility purposes. The Feasibility Visit would include assessing our patient population, the clinical expertise, the Research Pharmacy capabilities and physical set up. If the visit is successful, the study team at our site prepares the regulatory paperwork to submit to the institution’s IRB and, if approved, we commence the study. As a Research Pharmacist, I am given the opportunity to sit as an IRB voting member.
We do all the oncology studies for the institution’s system that tend to be pretty complicated and scary for a lot of other pharmacists to deal with. I’m responsible to manage the oncology, renal transplant, neurology, anticoagulant studies, Alzheimer’s, acute cardiac studies and hepatology-related studies. Some of the other hospitals have investigational pharmacists that manage the inpatient antibiotic and vaccine studies. Our institution accepts both inpatient and outpatient studies.
Five percent of the position consists of what we call investigator-initiated studies.This is actually the more fun part of the job- when you get to define and run your own study. These are investigative independent studies, they are not funded. We literally write the protocol from scratch. We write the consent form ourselves. All of this has to be approved through the local IRB. Then we can go and get patients enrolled in our studies. I actually do the randomization myself on the computer. We do all that, as far as enrolling patients, getting consent forms started, creating data collection tools. Then at the end of the study, we compile the data, analyze it, and get it ready for submission to a journal in manuscript form.
The reason why I like to do that is when we have a question in the hospital about why we are doing something, that’s where I come in and say, “Let’s do a study. Let’s check it out.” We’ve answered a lot of internal questions, some of them small and some of them generalizable to other sites. Our aim is to improve the knowledge of medical science. We often share the results of our investigator-initiated studies to improve the quality of healthcare. Some studies have an impact on clinical practice. That doesn’t happen all the time, but it has once in a while. That’s why we do it.
I have a science background and clinical research has been my interest all along. This falls right in my lap to tinker around with the standard of care and question things that we do on a daily basis. It’s testing FDA approved drugs that are already on the market in a different way.
Tanya: How long have you been in clinical research?
Matthew: I didn’t get involved in clinical trials with human studies until about ten years ago. Prior to that, I was doing non-clinical lab studies with animals.
Tanya: Have you observed any changes or trends in clinical research, ten years ago compared to now?
Matthew: There’s a big movement by NIH right now to centralize the IRB process because the problems that investigators have had historically with studying cancer drugs, going through all the local IRBs is slowing down research. NIH said, ” We need to do this better. We need to get more trials going with more patients enrolled so we can find a cure for cancer.” It’s a very noble endeavor. They’ve gotten to be very successful with it in the last few years, with buy-in from everybody, including having the very big pharma and drug companies get together and say, “Let’s work together instead of against each other.” That’s something that I did not see ten years ago. That’s pretty new and it’s moving forward.
The thing that’s changed with cancer research is that instead of finding a drug for a certain site of a tumor, like breast cancer, colon cancer, or brain cancer, they are looking at the tumor profile itself and the dynamics of the mutation. Having drugs work on mutations versus where the mutation is taking place in the body, it makes a lot of sense. Melanoma is pretty much the only cancer that is not site-related that actually has the right nomenclature. With breast cancer, colon cancer, and lung cancer, you’re just naming all these different cancers that are very site specific, when the tumor can be mutating in different ways in that certain site. That’s why doing research for breast cancer has been dysfunctional because sometimes it works, sometimes it doesn’t. That’s because the tumor profile is vastly different from one cancer to the next.
The whole approach now is to design a drug that goes after a tumor type, versus the site of the tumor. That’s another thing that has remarkably changed in how research is done with cancer, especially from ten years ago to now.
It’s pretty fascinating how that all works. But they’re getting somewhere finally. Immunotherapy has changed the landscape of treatment with cancer. It really has. You’ve probably heard about it everywhere, including Time magazine, about how great immunotherapy is.
The whole story with immunotherapy has been very bumpy from about 20 years ago until now, because immunotherapy was considered by oncologists as witch doctor science—” it doesn’t work and you should be ashamed of yourself for going into that type of research.” There were some pretty brave people to go up against that. These guys were criticized. They were chastised within the medical communities. They finally got such good results that it was undeniable. We need to do more research in that area.
The story of immunotherapy, it was not as smooth as you may think. Now it’s a no-brainer. I’m glad those people prevailed and we’re going in the right direction.
Tanya: What are some of the biggest challenges that institutions like yours face when conducting clinical trials?
Matthew: There’s a variety of challenges. One challenge is getting patients to enroll in these studies. It’s not the easiest thing in the world. Sometimes these studies are designed in a way where 99.9% of the patients you see with a particular cancer will be denied access to that trial. That’s a challenge because when you get a funded study from Bristol-Myers Squibb, they cannot change the protocol once it’s written. Even to the point where we have too many exclusion criteria or too many inclusion criteria for anyone to be enrolled in the study. It’s very difficult to enroll in a study with inclusion and exclusion criteria the way it’s written. That’s one challenge that we commonly get in the hospital with certain types of studies such as pancreatic cancer and head and neck cancer. In brain cancer, it is very difficult to enroll those patients.
Advertising for these studies is starting to get more organized, with MD Anderson, Cleveland Clinic, Stanford, Harvard, Johns Hopkins, and some of the big cancer places coming together and giving patients one list where they can pick a site that’s close to them that offers a particular kind of trial, and what it’s all about.
There’s a government-run website called Clinicaltrials.gov that lists a lot of these trials. Some of the internal trials are closed- for example, unless you are a Kaiser patient, you cannot be involved in most Kaiser studies. That’s one step in the right direction of giving patients an easier list of places where they can recruit themselves. I think that’s where the patient pool really increased because when a patient goes to be enrolled in a study, it’s not like the site is trying to convince the patient to be in the study. That’s a very different kind of mindset that is a lot better for enrollment.
We have challenges in the hospital that have to do with space. That’s a common denominator with a lot of hospitals, where you run out of space to do these trials because there isn’t enough space in the hospital. That would be more of a logistical challenge versus a clinical challenge.
Tanya: What about training research staff? That’s something that gets brought up a lot.
Matthew: That’s a big challenge. In fact, one personal challenge I have is to try to get someone to cover for me when I go on vacation. Keeping people trained in this position is a big challenge. Right now we have over 50 active studies that are all different from each other. Each study has a separate training log and delegation of authority log that needs to be signed off by the Principal Investigator prior to that pharmacist touching the study drug. It’s very challenging getting that next person up to speed with this kind of stuff because it’s so non-mainstream, what we do in the clinical research setting.
Please cite this article: “Matt Geriak, investigational research pharmacist, on clinical research trends.” Clinical Research Currents, June 6, 2019. https://clinicalresearchcurrents.com/matt-geriak-investigational-research-pharmacist-talks-about-changes-in-clinical-research/