Feature Article

Clinical Research Resources at BUMC:
Services and Opportunities for Collaboration

By Tom Moore, MD
Associate Provost for Clinical Research
Director, Office of Clinical Research
(With editing assistance from Mark Klempner, Nancy Kressin, Suzette Levenson, Lou Fiore, Phil Wolf, Raul Garcia, Michael Christman, and Sue Fish.)







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This month, we thought we would do something different. Rather than a formal educational article on some clinical research topic, we thought we would provide a list of the many clinical research resources that can be shared by any clinical investigator at BUMC. There are resources to help you find colleagues with similar interests, shared databases (and collaborators to help you use them), a functional MR center, and, of course, the General Clinical Research Center. Many are free services. Some have user fees. The links embedded in the article below will provide more detailed information about each resource. We hope we can point out some resources you weren’t aware of that will be valuable to you.

Office of Clinical Research (website): The Office of Clinical Research (OCR) is a clinical research resource for the entire Medical Center. Tom Moore, MD, Associate Provost for Clinical Research is the Director of the OCR. The mission of the OCR is to support and enhance high-quality, high-value clinical research. It does this particularly through educational programs. Examples include:

  • The Master of Arts in Clinical Investigation. This master’s degree program provides formal didactic training in the skills of clinical research. Students come from a variety of backgrounds including Baccalaureate degrees, PhDs, and MDs. Dr. Moore is the Director of this degree program.
  • Monthly, online Clinical Research Times
  • A monthly Clinical Research Seminar. Co-sponsored with our GCRC, the seminar covers a variety of topics of interest and importance to our clinical researchers. The Seminar is particularly popular among research staff and attracts 60-90 attendees each month.
  • Responsible Conduct in Research training. The OCR organizes and manages the Responsible Conduct of Research Program that is required for all research trainees who are supported by NIH funds.

The OCR also assists investigators find interested industry partners for collaborative research and has developed a self-reported, searchable database for BUMC clinical investigators and their research interests (BUMC Clinical Investigator Search). (No charge for services.)




Office of the Associate Provost for Research (website) (638-7654): Mark Klempner, MD, Associate Provost for Research, directs this office which stimulates multidisciplinary research among investigators in the Departments and Schools at the Medical Campus, at Boston Medical Center, and with investigators in allied fields at Boston University’s Charles River Campus, e.g. the Schools of Engineering, Arts and Sciences (Biology, Chemistry, Physics), Social Work, Sargent College, The Photonics Center, etc. This office also promotes the development of new shared resources that are needed for cutting edge biomedical research and provides administrative support for multidisciplinary research applications for research funding. The Office assists faculty with research strategic planning and assessment of institutional capabilities and has developed a Research Resources web-based database to identify researcher interest, expertise, and catalog of currently funded projects. (Research Resources for the BU-BMC Community). (No charge for services.)

General Clinical Research Center (website): The GCRC is a key clinical research resource at Boston University Medical Center (BUMC). It is located at the center of the medical campus (Evans 7). The overall goal of the GCRC is to provide a setting for patient-oriented, clinical investigation by faculty members of the Boston University School of Medicine, in particular those funded by NIH grants. The GCRC provides inpatient and outpatient facilities, a core laboratory to carry out non-routine sophisticated assays, a specialized equipment laboratory, and biostatistical and data management resources. Funds are available to purchase additional equipment for shared utilization (examples of such on the unit include an echocardiography machine and a state of the art bone densitometer). Michael F. Holick, MD, PhD is the Program Director of the GCRC. Additionally, our Center has a dedicated Dental Unit, directed by Thomas Van Dyke, DDS, PhD.

The BU GCRC also plays an important role in the training of new clinical investigators on campus. Peter Merkel, MD directs the GCRC Clinical Investigator Development Program (CIDP). This program identifies clinical research trainees, links them with mentors, and provides “hands-on” training in research methodology and completion of a research project. Different components of the CIDP include the Summer Medical Student Research Program and programs targeting research fellows. (No charge for services. Supported by an NIH grant.)

Center for Biomedical Imaging (website): This Center (opened in March, 2004) provides imaging capabilities specifically for Boston University investigators. Its Philips 3 Tesla Intera MRI scanner provides 6 independent channels for parallel imaging capabilities (so called SENSE imaging). It offers access to all levels of pulse sequence and hardware development from Philips. Capabilities of the 3T systems include all rapid imaging techniques in multiple contrast (weighting) options; dynamic studies (fMRI) using both spin-echo, gradient echo, and CBF- enhancing techniques; connectivity, for the detailed reconstruction of white-matter fibers and the diagnostics of white-matter disease; and spectroscopy with 2D and 3D chemical shift imaging for large volume studies. The Center Director, Dae-Shik Kim, PhD, and a center technician provide assistance and interpretation support. The Center was funded with institutional funds. Funded investigators are charged an hourly rate for magnet time, but 25% of magnet time is protected for unfunded research. Tom Moore, MD is the Chairman of the Center’s Oversight Committee. (Hourly fee for magnet time, although some time is available for unfunded, pilot studies.)

CHQOER (The Center for Health Quality, Outcomes and Economic Research ) (website): This Department of Veterans Affairs Health Services Research & Development Center of Excellence has linked its structure, operations and research themes with the Health Services Department at the Boston University School of Public Health. Dan Berlowitz, MD, MPH is the Center’s Director. The Center’s research concentrates on four domains: health quality assessment, outcomes measurement, health economics, and health statistics. Across these domains, researchers develop innovative methodologies and models of care to provide the most effective, efficient and appropriate care to our nation’s veterans. As selected examples of the research done at CHQOER, Dan Berlowitz’s analyses evaluating the quality of ambulatory care continue, including projects on validating a measure of hypertension care using administrative databases and developing a quality measure for glycemic control. Jack Clark, PhD studies outcomes of prostate cancer. Susan Eisen, PhD assesses the quality and outcomes of mental health care, including revising and validating the Behavior and Symptom Identification Scale (BASIS-32). The activities of Nancy Kressin, PhD focus on understanding reasons for disparities in care for dental, hypertension, and cardiac care. This Center is happy to share its expertise and its resources in collaborative research.

Data Coordinating Center (website): The DCC has been a data management resource center for the Boston University Medical Center community since 1984. Directed by Suzette Levenson, MPH, the 35 member staff of the DCC consists of statistical and database programmers, web developers, and data managers with expertise in study design, implementation of study protocols, development of computerized and web-based data collection and tracking systems, quality control procedures, and statistical analyses.

The DCC has experience providing leadership and organization for large multi-center clinical research projects. Responsibilities routinely include: design and creation of case report forms (CRFs) and data dictionaries, subject and data tracking systems, training site personnel in data management and quality control procedures, site monitoring/auditing procedures, creation of coding manuals and Manuals of Operation, project web site design and management, design and implementation of a wide variety of data entry systems with built-in range and verification capabilities, statistical analyses, and study closeout. The DCC also has experience working with Data Safety Monitoring Boards. Responsibilities have been to provide the DSMB with descriptive material to review as well as timely interim analyses and reports that monitor any adverse events. When planning to submit a grant, investigators can contact Ms. Levenson who will assist in writing the data management plan as well as developing an appropriate budget to cover the data management activities for the project.

Department of Health Policy & Health Services Research, Boston University Goldman School of Dental Medicine (website): The Department of Health Policy & Health Services Research, at Boston University Goldman School of Dental Medicine, and its NIH-funded oral health disparities research center (http://www.creedd.org), serve as resources for oral health research and training for trainees throughout the Boston University Medical Center. Its Chair is Raul Garcia, DMD, MMS. The Department's organizing principle is that its research efforts must serve to inform health policy, health promotion, and clinical care, with the aim of improving oral health outcomes. Dr. Garcia and his colleagues in the Department have expertise over a wide range of research areas, including current research projects on: access and utilization of dental care; oral health-related quality of life; epidemiology of periodontal disease, caries, and fluorosis; role of systemic diseases in oral health; role of nutritional factors in periodontal disease and tooth loss; effects of tobacco on oral disease outcomes; community surveillance and intervention studies to measure and reduce oral health disparities in children, elders and other vulnerable population groups. Staff have special expertise in the analysis of longitudinal data as well as the use of large epidemiologic and administrative databases for the study of oral health outcomes, including the VA Dental Longitudinal Study, the largest and longest-running study in the U.S. of oral health in aging. This Department is happy to share its expertise and its resources in collaborative research.

Framingham Heart Study (website): The Framingham Heart Study, now in its 56th year of continuous operation, is one of the premier epidemiological studies of cardiovascular disease. Much of the decline in the incidence of heart disease in the past half century can be ascribed to knowledge of risk factors acquired in the Framingham Study. In fact, the term “risk factors” was coined by William B. Kannel, M.D. one of the original Directors of the Study and emeritus Professor of Medicine at Boston University School of Medicine. The Framingham Heart Study was begun in 1948 under the direction of the NHLBI. The objective of the Framingham Heart Study was to identify the common factors or characteristics that contribute to CVD by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of CVD or suffered a heart attack or stroke. There were 5,209 men and women in the original cohort (1948) and 5,124 of the original participants' adult children and their spouses were recruited in 1971. The Study is now enrolling third-generation subjects. Since 1971, the Framingham Heart Study has been conducted in collaboration with Boston University.

Dr. Philip Wolf, Professor of Neurology and Research Professor of Medicine at Boston University School of Medicine is principal investigator of this contract. There are tremendous opportunities to develop projects utilizing Framingham Heart Study data, including genetic data and samples. In addition to studies of cardiovascular disease and stroke, the Framingham Heart Study is also the setting for epidemiological studies of osteoarthritis, osteoporosis, Alzheimer’s disease, pulmonary disease, sleep disorders, visual impairment, hearing loss and others. You can learn more about accessing data from the Heart Study by visiting its NHLBI web site or by contacting Phil Wolf.

MAVERIC (Massachusetts Veterans Epidemiology Research and Information Center) (website): The MAVERIC supports longitudinal, epidemiologic cohort studies of veterans with the variety of disorders, and it offers opportunities for development of new research projects. MAVERIC, located at the Jamaica Plain campus of the VA Boston Healthcare System, is co- directed by Lou Fiore, MD, MPH and J. Michael Gaziano, MD, MPH. MAVERIC staff have expertise in handling national as well as regional administrative and medical care VA and Medicare datasets. MAVERIC’s mission is to be a national resource to foster epidemiologic research in the VA with a community of ad hoc consultants and faculty with expertise in all disciplines of epidemiology; the necessary infrastructure to support a highly relevant epidemiologic research agenda including a core computing facility and core laboratory for blood specimen processing and storage; a clearinghouse for VA and non-VA databases and the expertise to harvest them for epidemiologic research projects and pilot studies; a training center to educate both young and established VA investigators in epidemiologic research methods; and an information dissemination center for transfer of relevant epidemiological information to VA health care providers and administrators system wide. A thriving program in pharmacoepidemiology takes advantage of the availability of VA pharmacy files for all 4.2 million veteran subscribers, merging these files with laboratory files and ICD-9/PCT files.

The Clinical Trial Coordinating Center at MAVERIC is a core resource for the VA Cooperative Studies Program. Existing toolsets for the conduct of clinical trials include a 21 CFR 11 technically compliant web-based electronic data capture system built in .NET framework using SQL Server and CDISC XML data standards. This system satisfies the upcoming FDA submitting standards for e-trials. For clinical trial management MAVERIC has developed collaboration and document management tools using web services from Microsoft (SharePoint Server). Expertise in all aspects of large and small scale trial design, implementation management, IT regulatory compliance (including systems validation) are in place and are available for competitive fees or for collaboration on grant applications.

Microarray Resource Center (website): The goal of the Microarray Resource Center (based in the Department of Genetics and Genomics) is to help both clinical and basic researchers at B.U. apply the power of genome-wide experimentation to their research projects through the use of microarray technology. Microarrays make it possible to perform standard molecular assays such as genotyping, measuring gene expression, DNA resequencing, analysis of chromatin immunoprecipitations, and analysis of alternative RNA splicing simultaneously across the entire genome of any organism. The Resource uses both commercial arrays from Affymetrix that can contain up to five million distinct DNA sequences arrayed in an area about the size of a nickel, as well as custom oligonucleotide arrays spotted onto glass slides that are manufactured at the Microarray Resource. Over the last year, the Microarray Resource has analyzed about four thousand microarrays for about sixty different research groups at BU and elsewhere. The resource has received enthusiastic support for its rigorous quality control process, ability to consistently produce high quality data, and the detailed help they provide with experimental design, data analysis and bioinformatics. For gene expression studies, users of the Resource only need to provide the Resource with a small sample of total RNA and the Resource handles the rest. (Charges fees for services.)

If we have omitted a research resource that you are associated with, please forgive us. Let us know about this resource so that we can include it in our next listing. Please send an email to crtimes@bu.edu.

The Clinical Research Times is not published in July and August, so have an enjoyable summer. See you in September, with the return of the Clinical Research Times, complete with quizzes.

Many thanks to Jon Korn for graphics.



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