**GMS CI 675 Designing Clinical Research Studies
Prereq: Consent of instructor.
This course lays the foundation for, and serves as a prerequisite for many of the courses in the MSCI 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.
Prereq: GMS CI 675 Designing Clinical Research Studies and Conduct and Consent of Instructor.
This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles with 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 activities to expand the interpretation of the regulations, 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 on-the-job situations, and a final presentation to share the learning with the entire class.
Viegas & Merhaut . 4 cr, 2nd sem, Spring.
Prereq: Premedical course requirements and 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 Designing Clinical Research Studies and 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. Students will also be required to write three article critiques. Pairs of articles will be available for critique, each pair consisting of an article from the biomedical literature and a corresponding article from the newspaper or internet.
Fish & Hess Pino, .2 cr, 2nd sem, Spring.
A student would only register for this course if they plan on using the practicum towards the 32 credit requirement. Please see your academic advisor to get this approved before you register for this course.
Var cr [up to 4 cr], Fall, Spring and Summer.
A minimum of 14 credits is required in elective coursework: A wide variety of courses offered in the Division of Graduate Medical Sciences will count toward elective credit. A minimum of 14 credits must be taken as electives, directed study or practicum. Up to 4 credits may be taken as the practicum. Please ensure that your electives are approved by your academic adviser before registering for them.
**Please note, these are just some of the many electives offered through the Division of Graduate Medical Sciences and BUSM that previous MSCI students have taken. A wide variety of research related courses are available through the Division of Graduate Medical Sciences (GMS Research) and Boston University Medical Campus. The complete course catalog for the Division is available. Please be sure to consult with your adviser before registering for any elective courses.
GMS CI 660 Good Clinical Practices in Clinical Research
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. Group discussions and guest speakers help students learn practical skills. Malikova. 4 cr, Summer II.
GMS CI 680 Ethical Issues in Clinical Research
Prereq: consent of instructor Students examine the development and implementation of regulatory as well as ethical issues involved with conducting clinical trials. Topics covered include: protection of human subjects, privacy and confidentiality, conflicts of interest, negativity toward clinical trials, research on vulnerable subjects, genetic testing and genetic research. Also included are discussions of current ethical issues in clinical research within the media. Baedorf-Kassis, 2 cr, Spring.
GMS CI 671 Applied regression analysis with Computing
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.
GMS CI 793 Professionalism & Thesis Development
Prereq: CI 675 & CI 790 To provide CI students with knowledge of and experience in professional standards, and (2) guidance in developing a thesis proposal and writing a masters level thesis. 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 theses. Hess Pino, 2 cr, Summer I
GMS CI 691 or 692 Directed Studies in Clinical Investigation
Directed study provides the opportunity for students to explore a special topic of interest under the direction of a MSCI faculty member. Students may register for 2 credits of directed study by submitting a paper registration form, after the MSCI faculty member has agreed to work with the student on a specific project. Directed studies with a non-MSCI faculty member or adjunct member must first be approved by and assigned to the Director or Assistant Director of MSCI as Faculty Sponsor. MSCI Directed Study Form
GMS CI 801 or 802 Thesis Research in Clinical Investigation
Prereq: 32 credits of course work. The clinical research thesis 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, 2 cr, variable
GMS MS 621 Bench to Bedside: Translating Biomedical Innovation from Laboratory to the Marketplace
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.
GMS MM 710 Molecules to Molecular Therapeutics
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.
GMS AN 715 Professional Skills for Students in the Biomedical Sciences
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.
GMS PM 730 Introduction to Medical Pharmacology
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.
GMS PM 800 Advanced General Pharmacology
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.
GMS PM 881 Drug Discovery and Development
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.
GMS MS 793 Fundamentals of Medical Biotechnology
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.