Course Offerings

Prereq: Consent of instructor.

This course lays the foundation for, and serves as a prerequisite for many of the courses in the MSCR program. This course covers important epidemiological principles necessary for designing clinical research studies. Topics include bias, confounding, developing the research question, defining an appropriate study population, choosing outcome measures, clinical research ethics and regulation, sample size determination, and statistical analysis issues. Students will design and present a clinical research study during the course.

Hess Pino & Weinberg. 1st sem, 4 cr, Fall.

Prereq: Consent of Instructor.

Course explains the regulatory requirements for healthcare products, that is, drugs, biologics, diagnostics, and devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provided is an in-depth review of the pertinent FDA regulations and guidelines and links these to the scientific and logistical activities involved in taking a product from research to market.

Content and preparation of regulatory submissions, including an Investigational New Drug Application (IND), an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologic License Application (BLA), a Pre-Market Approval Application (PMA), and a 510K PreMarket Notification are described. International requirements for health care products are also reviewed.

Auwles. 4 cr, 1st sem, Fall.

Prereq: Consent of instructor.

This course is designed for Clinical Research Associates and other students with no prior experience with statistics who want to utilize computer software in performing statistical analysis. Topics include the collection, classification, and presentation of descriptive data; the rationale of hypothesis testing; experimental design; t-tests; correlation and regression analysis; and analysis of contingency tables. Laboratory course.

Travison. 4 cr, 1st sem, Fall.

Prereq: GMS CI 675 or Consent of Instructor.

This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles with an explanation and analysis of selected portions of the Code of Federal Regulations (CFR), applicable to clinical research during the new drug development process. The case study approach is used in this course since the drug development industry translates these regulations into both written and unwritten standards, practices, and guidelines. Each session will use interactive lectures to expand the interpretation of the regulations, into an operational and organizational focus, further integrating real-life issues into the classroom. In order to ensure that classroom learning is linked with the students’ work experiences, there will be an outside project required which will incorporate the course work with the simulated on-the-job situations, and a final presentation to share the learning with the entire class.

Volpe. 4 cr, 2nd sem, Spring.

Prereq: GMS CI 675 Designing Clinical Research Studies or Consent of instructor.

The goal of this course is to provide students experience in reading and evaluating current literature that may be pertinent to the origination, design, implementation and evaluation of clinical research . The course is conducted in a seminar format.

Each week, students read and critically analyze assigned readings of recent literature which may be relevant to clinical research about human diseases. Teams of students present their reviews of the assigned article and then lead the discussion during which the entire class participates. This format provides an opportunity to learn to critically evaluate the scientific literature and to develop oral presentation skills.

Hess Pino & Weinberg, .2 cr, 2nd sem, Spring.

Students will take CI791/792, (“Clinical Research Practicum”) for a minimum of 2 credits. The total number of credits allowed for the practicum will be variable from 2-4 credits.

NOTE: If a student will be fulfilling the practicum through their usual work experience they may not earn credits; a student is not permitted to get paid and earn credits simultaneously for the practicum.

Please see your academic advisor to get this approved before you register for this course.

Hess Pino, Var cr [up to 4 cr], Fall, Spring and Summer.

Prereq: 32 credits of course work.

Students will take CI801/802, (“Research”), for a minimum of 2 credits.  The total number of credits allowed for research will be variable from 2-4 credits

The capstone project provides a culminating experience and applies the principles and methods learned in the coursework to a real-life clinical study. To demonstrate the student’s understanding of the clinical research process from both a theoretical and a practical point of view.

Hess Pino, Var cr [up to 4 cr], Fall, Spring and Summer.

Prereq: consent of instructor.

Introduces regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed on GCP compliance fro m an industrial perspective. Topics include: selecting qualified investigators; obtaining ethical approval for patients, and initiating sites successfully. Lattanze. 4 cr, Fall, Online.

Prereq: consent of instructor

This course examines evolving ethical and legal issues in the biosciences. Students will study the legal and ethical issues pertaining to work with human subjects both existing and historical. They will go through the historical background that set the standard for today’s existing regulations and how those regulations are still in flux. Each student will do a presentation on a topic that relates to his or her own interest or existing research. Legal cases that have come from clinical research will also be covered. The course will involve class discussions, student presentations, case analyses and in-class lectures. Buck, 2 cr, Summer 1.

Prereq: CI 670.

This course covers analytic and computational methods for modeling and regression analysis in the biomedical sciences. Emphasis is on fitting exploratory and inferential models to data in epidemiology and clinical trials. Topics include tabular and graphical summary; the linear, logistic, and Poisson regression models; the Kaplan-Meier method and Cox proportional hazards analysis; power calculation; estimation of effect size. Analyses are presented and completed using the SAS and R software packages. Lecture and laboratory exercises are structured around worked examples from the recent biomedical literature. Evaluation is via homework assignments, a midterm examination, and a final project and presentation. Travison. 3 cr, Spring sem.

Prereq: CI 675 or consent of instructor

To provide CR students with knowledge of and experience in professional standards, and (2) guidance in developing a capstone proposal and writing a publishable paper. Topics will include professionalism & professional standards including professional communication, networking and resume and cover letter writing; formal and scientific writing skills, guidance in developing a research topic, and writing a thesis proposal and thesis. The primary aim of this course is to help students adjust from an informal writing style to that required for scientific communication, presentations and publications. Buck, 2 cr, Spring

Directed study provides the opportunity for students to explore a special topic of interest under the direction of a MSCR faculty member. Students may register for 2-4 credits of directed study by submitting a paper registration form, after the MSCR faculty member has agreed to work with the student on a specific project. Directed studies with a non-MSCR faculty member or adjunct member must first be approved by and assigned to the Director or Assistant Director of MSCR as Faculty Sponsor. MSCR-Directed-Study-form

Prereq: consent of instructor. This course covers intellectual property, licensing, and the core aspects of planning, creating, funding, and building new entrepreneurial ventures. Cross disciplinary teams are formed to evaluate current BU translational research projects and their potential as the basis for a start-up company. Gupta 4 cr, Fall.

Prereq: consent of the instructor. This course is designed to provide instruction in all aspects of the translation of basic research observations into clinical applications, using a case study model. The first case study will focus on sickle cell anemia. Lectures will review the molecular genetics of the disease and explore animal models for study of sickle cell anemia and will include laboratory exercises as appropriate.

The course will address treatment strategies for sickle cell disease, including pharmacologic manipulation of globin gene expression, structural biology and rational drug design, and gene therapy. Additional topics related to clinical trials development will be covered including ethical issues, regulatory affairs, statistical considerations in clinical research, and outcome analysis. Required of all molecular medicine graduate students. Steinberg. 4 cr, Spring.

Prereq: consent of instructor. This course discusses many of the professional skills and ethical issues that are part of an academic biomedical career. Some of the topics include funding mechanisms, determination of authorship, intellectual property, conflict of interest, human and animal subject protection, reviewing responsibilities and mentoring. Zucker. 2 cr, Spring.

Prereq: consent of instructor. Principles of pharmacology are covered and several major classes of therapeutic agents, with attention to their mechanisms of action. Issues of current and future concern in medical pharmacology are addressed including problems of drug abuse, the ethics of human experimentation, the pricing of new drugs, and new biotechnological approaches to drug design and development. Walsh, staff. 4 cr.

Prereq: consent of instructor. Lectures and discussions on the major classes of pharmacologic agents, with special attetnion to molecular, cellular, and physiologial mechanisms of therapeutic effects. Boyde, staff. 2 cr.

Prereq: consent of instructor. This course will address the discovery and development process for small molecule and protein drug products. Topics will include target identification and validation, lead optimization and selection of drug candidates for clinical testing, and the objectives and design of clinical trials. Williams and Farb. 2 cr.

Biotechnology is emerging as one of the fast growing and dominant technologies of the 21st century. It represents a bridging of innovation between physical, biological and medical sciences and depends on entrepreneurship and public acceptance. Medical biotechnology involves the rapid and prudent transformation of basic scientific and medical discoveries into products for the marketplace. This fast-paced transformation creates an urgent need for qualified, capable individuals to promote and manage the rapidly-evolving innovative technologies in a highly complex and competitive ethical, legal, and regulatory environment. Professionals who aspire to become leaders and managers in the emerging field of medical biotechnology must develop a profound understanding of the complexity of medical biotechnology and acquire the needed tools to steer it to a successful outcome. This course introduces students an awareness of the complexities and drivers of medical biotechnology. Franzblau & Traish, 2 cr.