Thursday, July 15, 2010

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)



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