Editor’s Note: Clinical research professionals find employment in the field in a broad array of settings, both in geographic and programmatic terms. From educational to regulatory matters, patient recruitment to monitoring, ethics review to data management, and so much more, the diversity of training, backgrounds, and viewpoints that individuals bring to the profession are part and parcel of what makes clinical research such a vital and rewarding career. This is the first in an occasional series of Q&As with personalities who are keeping the field strong in these times of change and challenge. Some of the earliest articles in this series, like this one, will focus on people and programs based in the Boston area, which hosts the ACRP 2008 Global Conference & Exhibition in April. Later installments will spotlight professionals in other parts of the U.S. and the world at large. Please send your ideas about whose “Voices from the Field” you would like to hear to gary@acrpnet.org.

Boston University’s School of Medicine launched its Master of Arts in Clinical Investigation (MACI) program in 2001 to teach students the scientific fundamentals of human research. The 32-credit program provides an in-depth look at trial design, trial management, biostatistics, ethical issues, and clinical research regulations. Students learn how basic science discoveries translate into clinical investigation and new therapies, and they gain hands-on involvement in a clinical investigation practicum under a scientific mentor. This project forms the basis for the student’s final research thesis.

Following a visit by the Wire editor to the MACI offices on the Boston University Medical Campus, a faculty member, an administrator, and a student generously shared the following answers to some questions about the program.

Susan S. Fish, PharmD, MPH, is faculty codirector of the MACI program and a professor of epidemiology and biostatistics.

Q: What drew you into teaching about clinical research, and in particular, to teaching in MACI?

A: I have been working in clinical research for more than 25 years, and have found that teaching others to perform high-quality research is more rewarding to me than doing the research myself. Thus, for the past 18 years I have been teaching researchers and research staff various aspects of research methodology and clinical research ethics. Because the MACI program attracts students who want to “specialize” in clinical research, they are motivated to learn the material, do the work, and engage in discussion. An instructor can’t ask for more than that.

Q: In general, do you think that incoming students have a realistic or well-formed understanding of the complexities and career opportunities of clinical research? If not, what might be done to better prepare them for postgraduate studies with programs such as MACI?

A: Some students have been working in clinical research for a period of time prior to matriculating in the MACI program. Others have only read about careers in clinical research. Because all of the MACI faculty work in clinical research, the course discussions frequently expose students to a variety of careers in the field. In addition, the program sponsors a series of seminars, Careers in Clinical Research, where students have the opportunity to hear about career options and ask questions.

Q: When the semester comes to a close, what is the top message that you want to leave your students with in each of the courses you teach?

A: Always ask yourself, “Would I enroll myself or my loved one in this research study?” If the answer is no, then you must question your work. Only perform scientifically valid and ethically sound research.

Q: What would your “dream course” be if you could tackle any topic that you have not yet been able to teach, and why?

A: A discussion course on advanced topics in clinical research. There is so much in the news, almost on a daily basis, that current events become a part of every course I teach. However, the curriculum requires that we cover a certain amount of material, so we never have enough time to discuss in depth the issues brought up by these current events. To have the luxury of time to fully discuss topics, such as the ethics of placebo, is voluntary consent possible, adaptive study designs, etc., would be glorious.

Q: Is there anything else you want ACRP readers to know about the program?

A: The MACI program works to provide basic education in aspects of clinical research, and to provide courses that will meet the needs of the student. Our goal is to improve the clinical research being conducted to ultimately improve the health of patients.

Linda Zimmerman, MS, is the program administrator and manager of outreach for the Division of Graduate Medical Sciences in which MACI is housed.

Q: MACI is now six years old. How has the program evolved since 2001, and what are the major trends in the clinical research industry or higher education that prompted these changes?

A: Over the last several years, MACI has become more academically rigorous to align with the increasing complexity of patient-oriented research. Also, a major trend in higher education is to offer more interdisciplinary degree programs. As our student population has become more academically and professionally diverse, we have created a more flexible program with a wide variety of electives from disciplines such as medical sciences, public health, and management.

Q: Please describe what qualities you would like to see in the “average” incoming student. Compared to this description, do you think that the backgrounds of students who are interested in programs like MACI are changing, or will change, as clinical research gains a higher profile as a career option?

A: When the program first started in 2001, many of the students had undergraduate backgrounds in basic or life sciences. While this is still true, some students are nonscience majors, but have either done research or discovered an interest in clinical research through a personal or professional experience.We would like the “average” incoming student to be motivated by the academic challenge of graduate school, and the opportunity of being fully involved in all aspects of a clinical research project.  Yes, clinical research is definitely gaining a higher profile as a career option. As you know, there is a shortage of qualified clinical research personnel, and the demand for well-trained professionals continues to outpace the supply. Regulatory affairs, data management, project management, and study monitoring are areas within the clinical research enterprise that increasingly seek well-trained professionals. In addition, MACI is attracting individuals with professional credentials (MD, RN, RD, PhD) who wish to integrate their current expertise with a strong academic background in clinical research—in some cases, to pursue specific goals or interests.
 
Q: The clinical investigation practicum plays a big role in MACI. How successful has the program been at matching students up with appropriate research projects both within the Boston University Medical Center system and with external investigators, and what are the expansion possibilities for such activity, assuming the program grows over time?

A: MACI has been very successful in matching students with research practicums that connect to their interests and goals. The campus has a vast array of resources, including many research institutes, centers of excellence, and ongoing clinical trials (more than 1,000 annually), which provide many options for on-campus practicums. Our program faculty has contacts with investigators and other mentors working in drug, device, and biotechnology companies or clinical research organizations. We work with the students to establish the best on- or off-campus practicum to meet their needs and goals. Expansion of practicums continues to keep pace with the growth of the program.

Q: What is the biggest challenge to keeping a clinical research education program thriving in the modern marketplace for higher education?

A: The development of new courses and seminars to keep pace with changes and innovations in patient-oriented research, translational research, and small- and large-scale clinical investigation and trials.

Q: Is there anything else you want ACRP readers to know about the program?

A: Yes, our faculty is superb, and graduates of MACI receive the advanced education they need to build interesting and fulfilling careers in  academia, biotechnology, the pharmaceutical and medical device industries, private research, healthcare organizations, hospitals, and consulting.

ACRP member Christina Marc, CCRC, is a student in the MACI program.

Q: How did you get interested in clinical research; how did you first learn about MACI; and what prompted you to enroll in it versus similar programs elsewhere?

A: Although I had always known I was interested in research, it was not until I decided to continue my education through Boston University Metropolitan College that I discovered the field. I was so drawn to it that I changed my concentration, and upon earning my undergraduate certificate in Clinical Research, I spoke to my advisor Connie Phillips and expressed my interest in pursuing a career in the field. Connie and a few of my other professors at the time, including Ronnee Yashon, were very supportive and instrumental in my decision-making process. The MACI program was still under development, but after researching it and other other similar programs in the area, I was convinced that the MACI program was most suited to me. The program offered a flexible schedule, with small, interactive classes taught by leaders in the field. My classmates would be continuing students and professionals in the field working at pharmaceutical, biotech, and medical device companies, hospitals, and other academic institutions.

Q: How are your experiences with MACI contributing to your career plans? Have those plans changed since you started the program because of new aspects of clinical research that you learned about through classwork or other sources?

A: The MACI program has provided me with knowledge and skills that I could not have obtained elsewhere. It was this educational background that prepared me for my position as a CRC at Beth Israel Deaconess Medical Center, where I worked on various studies in the areas of diabetes (including neuropathy, wound healing, hyperspectral imaging, and tactile sensation) and sleep apnea. I went on to earn the Donald, Jacob, Beulah Chayet scholarship at the center, and then with the encouragement of professors moved from academia to the pharmaceutical industry, joining Wyeth Research as a CTSS in April 2007. The experiences I had in the MACI program enhanced my ability to problem solve, analyze data, and design appropriate and relevant clinical trials.

Q: Beyond your classes and research, how do you stay current with trends in clinical trials?

A: By maintaining my membership in various professional organizations (including ACRP and SOCRA), obtaining my certification as a CCRC, and attending seminars, teleconferences, and workshops on current issues in the field.

Q: In order to prepare for the experience of studying with a program like MACI, what would your top recommendation be to a potential new student?

A: Be prepared to work hard and to be challenged by your professors and peers, to find yourself stretching beyond what you thought were your limitations.

Q: Is there anything else you want ACRP readers to know about the program?

A: The MACI program is outstanding. I cannot imagine what my life would have been like had I not been accepted into the program. The curriculum is cutting-edge and the faculty is outstanding; but more than that, you feel that you are part of a community dedicated to furthering the clinical research field. I have been fortunate to have had such a fantastic group of mentors and peers, each with their own expertise, background, and perspective to contribute, and I feel very blessed to be a student in the MACI program.