A Taste of IRB + A Pharmacy Student’s Battle Cry to Action

Yummmm. You see that delicious plate right there? That’s what you could be eating, if you went to the Institutional Review Board (IRB) meeting.

As a participant of the MCRiT program, a few weeks ago I was allowed to go to an IRB meeting. I got a first hand account on what happens during those important meetings.

For those of you unfamiliar with what the IRB does, essentially it is an ethics committee that must approve of all research studies before they can commence. In the past, researchers did not take into account patient safety, and many patients were seriously harmed or other ethical violations occurred. This led to the Federal Government creating these IRB to ensure patient safety in research studies. One way that the IRB works to ensure patient safety is by including non-researchers on the board: there was community representation, prisoner representation (prisoner participants in research has a cruel history), and other non-scientists present.

This is what the IRB meeting looks like:

Sitting in this meeting, it reminded me of the City Council meetings you see on C-SPAN. Everything was official and professional. I found the whole experience rather intellectually stimulating. To get a sense of what happens, imagine Dean Welage’s Evidence Based Medicine Class when we critically appraised articles and studies. Now imagine a room full of professional researchers who do this. You will hear words and phrases tossed around like: minor increase over minimal risk, APO (approved pending office), APR (approved pending reviewer). It again showed me how critical proper study design is – from recruitment and compensation to patient withdrawal policies. After they review the case, the board votes – favor, oppose, or abstain on the research proposal or amendment.

Here’s a picture of my mentor for the meeting. Thank you again Dr. Stephan Taylor!

The University of Michigan actually has multiple IRBs. We aren’t called the Leaders and Best without reason. I learned that there are 5 IRBs alone in the Medical School (for human subject research) and 1 IRB located on Central Campus for Health Behavior Research (psych, physics experiments, etc).

Sitting through the IRB, I learned how vital it is that Pharmacists be pro-active and take initiative to expand our profession. Unfortunately, there wasn’t any Pharmacy representation at the IRB I was in. I only hope that we are represented on the other IRBs because I know we have the clinical knowledge to be effective on these boards. There was a study pending approval regarding a prospective randomized control of simvistatin on the prevention of COPD being lead by a physician and not a pharmacist. I always assumed that we were the drug experts. Perhaps I need a better understanding of the US Health Care System and its politics. But regardless, my point is that we are at a tipping point in our great profession. The time to expand our scope of practice can only be achieved if we get out of our comfort zones of dispensing and demonstrate how we can improve patient care with our knowledge and training. UofM is teaching and preparing me the clinical knowledge, but I know it will be up to me to either actively participate or simply sit on the sidelines when I graduate.

I hope that by the time I practice, I will continue to have this fire to push our profession and inspire those around me to do the same.

Go Blue!

Next Steps...

Hey guys,

It feels like it’s been forever since I last updated. Life’s been busy with my friend’s wedding this past weekend and the week prior was my group’s Final presentation at the North Campus Research Complex (NCRC). I’m happy to say that the presentation went well! The grueling 3 hour meetings late into the evening to plan and prep helped immensely as our group walked out relatively unscathed from the barrage of questions from our Alzheimer's-Depression presentation for the senior clinical researchers, coordinators, and PI’s present in the audience.

Here is a picture of my awesome team.


Dr. Charles Burant, aka Chuck, if you’re reading this, thank you, thank you again for your dedication to mentoring our group. You definitely lead us, pushed us, and your experience with writing research grants helped us immensely as we were able to correctly predict what type of questions the audience were going to ask before the actual presentation. We were well prepared. Also, your enthusiasm is a rarity and I hardly see anyone who loves their job more.

Yesterday was my last day at the Taubman General Medicine clinic. I’ve reached the quota of patients and now shift my research responsibility focus into data entry and writing. I have over 200 surveys that I need to input into an Excel spreadsheet, then play around with the SPSS statistical software, and finally see what data I’ve obtained. Then I’ll write an abstract (due in a week, another deadline!), my report (what findings did I make/observe?) and finally make a poster of my results! I’m also hoping to write a paper and get it published, and have my own imprint in the science literature world (there’s something cool about contributing to knowledge). I’m excited because this will be my first poster, abstract, and report and I have BIG VISIONS for all.

I actually ran into a Psychiatry resident friend at my church a few Sundays ago, and told him the type of research I’ve been working on all summer. He was interested in what I’ve seen so far and my future results. He explained that at the psych clinic where he works, the doctors have been telling their patients about the inexpensive generic medication programs but they don’t know if their patients have actually utilized them. This is where my research can help. I will have REAL DATA to show how many patients (in general) have actually utilized an inexpensive generic medication program when the physicians or pharmacists tell their patients about such a program during their clinic visit. (As I blogged earlier, the Taubman General Medicine clinic doctors have informed their patients as well.) This research study could potentially open up more research opportunities, in that if we find that monetary reasons are not the reason why patients are not compliant in taking their medicine, then there must be some other variable that we are not aware of and need to investigate further. In fact, this outcomes report, I HOPE to distribute to ALL the physicians and pharmacists at the Taubman outpatient clinics at the University of Michigan Hospitals as well as the geriatric clinics who might benefit from reading the study.

The study may affect the way physicians/pharmacists practice to help their patients become more compliant in taking their medications, with the overall goal of seeing their heaths improve. I talked to Dr. Erickson about it recently, and what we’re doing this summer could potentially be an intermediate outcome (medication compliance), with the long term outcome being the overall health improvement of patients utilizing a generic inexpensive program. To monitor improvements in the patient's health we can obtain information from their charts and monitor their numbers (cholesterol, hA1c levels, blood pressure, etc). I would then try to get it published and possibly show how a physician/pharmacists intervention actually led to better health outcomes and that it can be implemented at hospital nationwide. Not bad from an idea that came from a summer research project.

Last thoughts on my time at the Taubman General Medicine Clinic: I’m grateful for the experience. It’s been a while since I’ve talked to real patients, and heard their burdens with their diseases, medications, and the U. S. health care system. Too often during the school year I’m just trying to survive my classes that I forget the reason why I went into health care – and that is to improve the lives of patients in a definite way. I’m also grateful for this summer experience because I got a chance to learn more about the state of Michigan (I’m from California). I constantly met retirees from the auto industry at the clinic and saw how important the auto industry is for Michigan residents and this made the recent downhill in the car industry more impactful to my life.

Finally, I ran into a Michigan Senator at clinic! Unbeknownst to me at the time, I asked Michigan Senator Robert Patterson to participate in my research. And after I found out he was a Senator, we got to talk about an assortment of topics before he was called in. We talked about the recent Michigan election, his thoughts on the recent (and future) health care reform, living a public life, and how hostile politics have become recently. Unfortunately he was called in before I could talk about ways that Pharmacists can be used to improve the health care delivery and system. But I did get a chance to take a photo with him and got his business card. This is one bridge I certainly want to continue building!

Deadlines Looming

Things are stressful at the moment. In 2 days, my group (composed of Pharmacy, Dentistry, and Social Work students) are responsible to submit a grant proposal and give a presentation about Alzheimer’s Disease. This is the final objective of the MCRiT summer practicum: participation in a “virtual group research project” . To guide us, we’ve been paired with Charles Burant MD, Ph.D, a professor in the School of Medicine who has been OUTSTANDING as a mentor. Unfortunately, we’ve only been given 2 weeks to make this project happen, and unfortunately, life doesn’t just stop when you have deadlines looming.

My observation is that research can start off incredibly slow and dry - when you’re being trained, trying to put a project together, or coming up with a hypothesis- , but can become quite stressful whenever deadlines approach ( ie annual reports, renewal of grants, presentation of work thus far). I’ve also discovered research doesn’t always end when the clock strikes 5 pm. These past few days, my day started with clinic but then afterwards have been filled with meetings and reading up on Alzheimer’s Disease in my free time. Some days there have been meetings that extended late into the evening to ensure we get our work done.

And your personal life doesn’t stop too. I went to a wedding on Saturday and I’m attending another in 2 weeks.

Though I’m super busy working on my portion of the Virtual Group project – I’m in charge of the data analysis ( statistics again!) and figuring out which statistical test is appropriate, patient safety ( to pass IRB) and the estimated budget (to hypothetically hire a Primary Investigator, study coordinator, purchase supplies, etc) – I really wanted to write this post and share what I think happens annually in research, and that is reporting and presenting what you’ve done all year. We’ve had seminars for each step of the research process – now it’s time to incorporate everything and demonstrate what we’ve learned in the past 9 weeks!

This is a picture of our whiteboard from a late evening brainstorming session to develop a testable hypothesis about Alzheimer’s Disease.

A Taste of Grey's Anatomy in Ann Arbor

Have you ever watched those medical shows with those handsome doctors who talk oh so lovely to their patients to enroll them into a clinical trial they are conducting? Well that's what my life has been like this summer except for the lack of a McDreamy hair cut and the fooling around with medical interns in the on-call room.

These past 8 weeks, I've been at the Taubman General Medicine Clinic at the University of Michigan Health System Hospital doing a study with the Pharmacists and Physicians on where their patients go to obtain their prescription medications. Co-blogger Alex Tungol actually did a similar study 2 years ago with Dr. Erickson through the summer MCRiT program as well. This gives me the ability to compare my results with hers, after I analyze my data with statistics. It will be interesting to see if any trends have developed in the two years. It's been a while since I've taken Statistics (and I never knew how significant it is to research) so this provides an opportunity to freshen up in my Excel and SPSS programing. Once I get my results, Dr. Erickson and I will analyze it, make a research poster, write a paper on it, and hopefully get published in a scientific journal!

For this project, specifically we're looking at whether the Recession and the two year advertisement campaign of the $4 inexpensive generic programs offered by major chain pharmacies ( such as Kroger, Walmart, and Target) have had any effect on the behavior of general medicine patients of where they go to get their prescriptions filled. We'll also be able to see if these incentive program have lead to increased medication adherence and other prescription behaviors. Furthermore, this outcome research affects the Physicians and Pharmacists directly at the Taubman Medical Clinic because many have been pushing their patients to utilize these types of prescription programs.

My primary job these past 8 weeks have been to enroll patients into the study. I've been humbled to say the least. From this experience, I now understand how difficult it is to enroll patients into any study - whether it be a simple 15 minute psychology study or a complicated clinical trial involving a new experimental drug for cancer patients undergoing chemotherapy. What I found to be alarming is that there are thousands of studies that are going on at UofM right now, but each year many studies lose their funding because they do not enroll sufficient patients the grant requires for their federal funding. This explains why I'm always bombarded with fliers (and now e-mails) asking me to participate in a study with cash incentives or ipod giveaways. It's serious business. And quite stressful if you're the clinical coordinator in charge of getting enough patients for the study. Your funding depends on it!

My study required me to enroll ~200 patients. To say it bluntly, I've never been rejected so many times in my life. Some days were good, others were not so good. Great days were when I enrolled 17 patients into the study and walked out of the clinic triumphantly! But there were many days when I only got 4 or 5 patients in a span of six hours at clinic and left feeling dejected. I guess in research, some days things will go your way, but other days they won't. The important thing is to persevere, not quit, and plan for the unexpected. A quote by Louis Pasteur provides insight : "luck favors the prepared."

One thing this research project has allowed me to do is to talk to patients again - something I haven't done so much since my days working at a community pharmacy. I'll be the first to admit, I do not have McDreamy hair or a McSteamy body, but I love to talk with people. My chief duties was to provide informed consent - specifically that the study was completely voluntarily and that there would be no benefit for participating. Since there was no compensation, I had to win them over with my McTastic smile! :)

I learned as much from the patients as they learned from me. I met at clinic a professional baker who explained to me the science of baking by enlightening me with how it's as much science as art - do not add too much salt when baking bread or the yeast will die and your dough won't rise! I met at clinic a couple who crossed the Canadian border monthly to get some of their prescriptions because of the drastic savings. And I even ran into the Dean of Admissions of the College of Pharmacy, Dean Perry, at clinic! She graciously volunteered to participate in my study (see the re-enactment picture at the end of the post)!

To pass the time on those extra slow days, I created activities to keep myself busy. I read.....a lot, and I kept a journal each day at clinic to record my observations and my thoughts. This practice is a good habit to develop now in my young professional career - to write down every observation I see in research. They are great resources to go back to when I write my final report but also helped pass the time on those extra slow days of research. I've found research to be a slow, methodical, surgical process....but without this process there would be no good science that results from it. I'll be keeping Louis Pasteur's famous words in mind: Luck favors the prepared.

If anyone has questions about MCRiT send an e-mail to me at : cqtruong@umich.edu

MCRiT Part 2 - Seminars

Besides participating in a research project under the guidance of a mentor doing hands-on clinical research, a second component of the Multidisciplinary Clinical Researchers in Training (MCRiT) program is to attend weekly seminars that guide us through the steps of the research process. What's really awesome about this component of the program is that we get to have lectures from some of the brightest people and seasoned veterans that do research at UofM. To illustrate my point, I'm going to share our experiences when the College of Pharmacy's own Dr. Bruce Meuller gave a lecture on Study Design.

If you're not aware of Dr. Mueller's teaching style, he prefers classroom interaction -inducing students to actively participate in discussion- rather than the traditional passive learning style (ie lectures) we've been accustomed to since grade school. His style was perfect for helping us design a mock research product proposal from its inception, to marketing it in front of a mock Board of Directors meeting.

We were split into 3 teams, and each team contained a plethora of skill sets and backgrounds: pharmacy, public health, clinical psychology, medicine, social work, and dentistry. My team was responsible for designing a good study that would show that our newly isolated compound, which has been formulated into an intravenous product against Pseudomonas aeruginosa, is safe and effective.

From this interactive workshop (a trademark of Dr. Mueller), I learned first-hand how intense it can be to design a study and why good study design is crucial no matter if you're a small startup company with a limited budget or a large pharmaceutical company. Without good study design from the start, your product will: 1. never get funding 2. never get approval by the FDA and 3. cost more money to re-do the study. Key questions Dr. Mueller made us pay close attention when designing our studies were :

what will we be measuring? when will we measure it?

who will be in our trial and who will be excluded?

where will the study be conducted?

I've also learned that the research process involves a whole different set of departments that we must go through in order to get it funded. New players introduced to me were venture capital firms- who often search the labs of the University to find good ideas that can be turn into a profitable business, a board of directors - who vote on projects their company will invest and partake in, and federal government agencies - such as the National Institutes of Health (NIH) and National Science Foundation (NSF) that award lucrative federal dollars annually to fund research.

The mock Board of Directors meeting showed me how competitive research can be. There were three groups with different products competing, but only one team that received the funding. While I’m happy to say that my group won (our study design is at the bottom), the victory was not all sweet. I realized that in research you must properly account for everything when designing and planning, otherwise your grant proposal or your project will be turned down. Think of the thousands of grants the NIH or NSF receive each year. They can’t fund everybody. Only those with the best study design with the proper outcome measurements will be awarded lucrative federal research money.

As I delve more into this research beast, I'm learning the importance of critically appraising everything I read in medical journal studies and analyzing for myself why the researchers designed their study in that particular way. Terms such as: cohort study, cross-over design, and minimal risk, are becoming part of my everyday vocabulary.

As promised, here is the new revolutionary drug that received the green light for funding from GoBlue Pharmaceuticals!: Weapon-X ( The code-name for Wolverine)

The MCRiT Experience

Hey guys,

Summer is definitely flying by and I have been busy with life, research, and hanging out that I haven't been able to do my part in contributing to the COP blog. This summer I've been blessed to be a participant in the Multidisciplinary Clinical Researchers in Training (MCRiT) program offered by the University of Michigan for doctoral Pharmacy, Medical, Dental, and Nursing students. The program is a total of 12 weeks, in which 10 are dedicated for the summer and 2 during the fall semester. It's already the 5th week and I have lots to update!

What's really cool about MCRiT is that you get to experience how research truly is a multidisciplinary process. From the onset during orientation, the other pharmacy students and myself participating in MCRiT were alarmed to be welcomed by our own Dean Welage!!! Not only is Dean Welage awesome in the College of Pharmacy, she's also actively involved (and a big fish) at the department that oversees major research going on at UOfM. She coordinated the Basics of Clinical Research seminar ( ie what is Clinical/Translational Research, intro to IRB, Informed Consent, etc). The audience was filled to capacity with people involved in research from multiple departments at UofM for example: clinical study coordinators, research administrators, post-doc fellows, etc. To be honest, a lot of the material was over our heads because a lot dealt with research policies and protocols at Michigan that are common for research which we haven't had a lot of experience with. But it was still awesome to be there, and to enjoy the complimentary meal -- i mean network session!

Essentially, the summer MCRiT practicum is a program composed of 3 core objectives: 1. Participate in a research project under a mentor doing ongoing research. I'm working with Dr. Erickson, and we're doing a cross-sectional study on patients and their pharmacy behaviors at the General Medicine clinic at Taubman Medical Center. Above is a picture of me of what a typical day at clinic involves. Professional attire, writing utensil, and clip board on hand. Ready to engage and recruit patients into the study!

I'll end it right here, but I'll conclude by saying how much MCRiT has opened my eyes (and have made me excited) for research. I never experienced how difficult it could be to enroll patients into a study, and I now understand why there are flyers advertising cash incentives to participate in psych studies. I'll update soon about the other objectives of MCRiT and more stories, but if anyone has any questions about the program, send an e-mail to me at : cqtruong@umich.edu