This course covers how to develop and implement a digital strategy to drive a health research organization’s online presence, specifically the processes for selecting, using, managing, and evaluating the effectiveness of web, social media, and mobile technologies. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

The goal of implementation science is to ensure that the knowledge and materials produced by health research actually leads to improved population health by: 1) reaching the people for whom they are intended; 2) being adapted to local circumstances; and 3) being implemented effectively, safely, equitably, and in a timely and patient-centered manner. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

This course provides skills in designing and carrying out a qualitative study useful for program management (planning, monitoring, and evaluation) and ensuring quality in health-care delivery. The methods included in the course are a sample of commonly used qualitative methods: structured and unstructured interviews, participatory learning methods, group and individual methods. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

This course provides students with a strong foundation in regulatory science and drug device development and a hands-on introduction to current good manufacturing, laboratory and clinical practices, as well as product development. It offers graduates unique instruction for the specialized jobs in regulatory science in federal, academic, and industry work settings. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

This course is an introduction to social network analysis (SNA) with an emphasis on clinical health applications. Students will gain an understanding of network theory and concepts, mechanisms for contagion, and familiarity analyzing network data in applied settings. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

This course offers practical guidance about how best to engage in interdisciplinary and multidisciplinary team science: to pursue complex science questions, to work effectively with team members, and to produce high impact research outcomes that help meet society’s needs. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

Prerequisite of 2 other courses

Students learn principles and practices of translational medicine applied to discovery and development of drugs, devices, and diagnostics. Topics covered include biomarkers, intellectual property, omics, translational imaging, pharmacogenomics-driven treatment, and discovery and development of diagnostics, stem cell therapies, and drugs. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

Prerequisite of 1 other course

Students will learn about the application of translational science principles and tools to accelerate and improve the efficiency and effectiveness of the discovery/design and development of biomedical products—from drugs/biologics and cell and gene therapy to medical technology. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

This course covers the basics of regenerative medicine for understanding what stem cell-targeted therapy is and what are the principles for taking a cell-based product from preclinical to first-in-human clinical studies. Topics covered include the regulatory, ethical, and study design considerations for developing stem cell-targeted therapies. Students will grasp the complexities of stem cell-targeted therapies and be able to understand the framework for developing new products. This course provides a good overview for those entering a field that may deliver stem cell therapies, stem cell-targeted treatments, or other cellular based therapies (e.g., car-t-cell). Prerequisites: admission to the MAS Clinical Research Program or consent of department.

Prerequisite of 1 other course

Students will gain a comprehensive and integrative operational understanding of an entire life science innovation cycle, from drug idea to market and back, through case studies done by mining publicly disclosed information in teams mentored by biopharmaceutical professionals. Prerequisites: CLRE 236 and admission to the MAS Clinical Research Program or consent of department.

Students will gain a real-world, comprehensive, and integrative understanding of an entire health innovation cycle, from ideation to commercialization of a biomedical product, through a case study. Prerequisites: CLRE 236 or CLRE 236R and admission to the MAS in Clinical Research Program or consent of department.

Building upon the case studies laid out in Applied Translational Research (CLRE 238), this course will analyze in depth specific issues by emulating the biomedical industry modus operandi. Mentored student teams will analyze publicly available information, develop a business case, and defend it in front of a jury of biomedical industry research and development (R&D) leaders. In the process, students will learn and apply teamwork and brainstorming techniques and tools. Prerequisites: CLRE 238 and admission to the MAS Clinical Research Program or consent of department.

The purpose of this course is to increase awareness about outreach, engagement, and retaining diverse populations in scientific research. The course is intended for trainees and researchers interested in learning how to plan and conduct research involving populations and communities who are historically underrepresented in research. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

Prerequisite of 2 other courses

This course will develop and apply the theory of clinical trials design and analysis, discuss the practical issues of financing and implementing clinical trials, and describe issues of monitoring trials and working in cooperative groups. The scholar will design and present a prospective clinical study protocol and participate in peer review of their colleagues’ work. Prerequisites: admission to the MAS in Clinical Research Program or consent of department.

This course will develop and apply the theory of clinical trials design and analysis, discuss the practical issues of financing and implementing clinical studies, and describe issues of monitoring trials/studies and working in cooperative groups. The scholar will design and present a prospective clinical study protocol and participate in peer review of their colleagues’ work. Prerequisites: admission to the MAS in Clinical Research Program or consent of department.

Prerequisite of 2 other courses

Scholars will recognize and understand different types of study designs, the relative strengths and limitations of each, and the proper choice of study design in conducting their own research. They will also be able to identify and calculate the correct measure of risk for each study design. Participants will recognize major sources of bias, confounding and misclassification, and understand design and analysis methods of dealing with each. They will also be familiar with criteria to differentiate association from causation. Class sessions may also be offered live via distance learning with established remote site.

Scholars will evaluate relevant outcomes in patient-oriented research from the patient (quality of life) and societal (economic) perspectives and locate potential resources for assessing the relevant outcomes in a wide variety of study designs. They will also be able to describe the relative strengths of different health services research approaches to a clinical problem. Finally, they will understand the components of clinical practice guidelines, including patient preferences, and how these guidelines both depend upon as well as inform patient-oriented research. Class sessions may also be offered live via distance learning with established remote site.

Prerequisite of 4 other courses

The course will introduce the fundamentals of biostatistics and basic methods for analysis of continuous and binary outcomes for one, two, or several groups. Hands-on data analysis using the R statistical software and clinical research applications. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

Prerequisite of 1 other course

The course will introduce statistical methods for clinical trials and observational studies in the context of causal inference. Methods for binary, continuous, and time-to-event data will include multiple linear and logistic regression and Cox proportional hazards model. Prerequisites: CLRE 253, admission to the MAS Clinical Research Program, or consent of department.

This course provides an orientation to database design and management and covers key issues regarding data handling for clinical research and clinical trials. Scholars will also become familiar with technology assessment and decision-making methods and analysis. Class sessions may also be offered live via distance learning with established remote site.

This course will review the ethics and basic regulatory issues for research involving human subjects, including access and confidentiality. Scholars will prepare a mock submission to an IRB for peer review and practice and will also review their peers’ proposals. Class sessions may also be offered live via distance learning with established remote site. Prerequisites: CLRE 250.

Scholars will select the appropriate sampling method and determine the sample size necessary for specific projects and adjust for confounding. Participants will be familiar with several specialized analytic techniques, including matched, cluster, and meta-analyses. They will also be familiar with methodological issues, unique to ecological, behavioral, and genetic studies. Class sessions may also be offered live via distance learning with established remote site. Prerequisites: CLRE 251.

Students participate in a series of seminars on professional development topics that will focus on skills and knowledge to enhance the ability of clinical researchers to be successful. Seminar topics may include research management, team building and collaboration, leadership skills, career development in the clinical research field, negotiation skills, research project management, and research budgeting/financial management. Prerequisites: MAS program or permission of department.

This course covers the key elements of scientific communication skills that are designed to enhance the clinical research’s ability to be successful. Topics include secrets of making good oral presentations and engaging the audience, how to write and prepare abstracts, basics of grant writing and submission, and how grants are reviewed. Course includes mock grant study section. Prerequisites: MAS program or permission of department.

Faculty member will direct a student’s study in selected professional development topics in clinical research. Specific content will be tailored to the student’s particular needs and interests. Students must make arrangements with the program and individual faculty member prior to enrolling in the course. Prerequisites: MAS program or permission of department.

The course will introduce statistical methods and techniques for analyzing medical data from longitudinal studies using R statistical software. Students will understand the challenges and statistical issues for designing and analyzing longitudinal studies, recognize and use longitudinal data analysis methods, and perform analysis. Prerequisites: CLRE 253 and CLRE 254, admission to the MAS Clinical Research Program, or consent of department.

The course provides an introduction to the use of decision sciences in health care. Student will be able to construct and evaluate an appropriate decision analysis probability tree, value health outcomes, use sensitivity analysis and understand how to conduct a cost-effectiveness analysis. Prerequisites: MAS program or permission of department.

This course will introduce advanced biostatistical methods including: meta-analysis, smoothing, Poisson and negative binomial regression, ordinal and nominal logistic regression, propensity score analysis, and analysis of time-to-event data with competing risks. Corequisite: CLRE 254. Prerequisites: CLRE 253, admission to the MAS in Clinical Research Program, or consent of department.

The course introduces tools and practices for predictive modeling of binary, categorical, and continuous outcomes, using the R statistical software. The methods include linear and logistic regression using LASSO, ridge regression and elastic nets, CART, boosting, bagging, and random forests. Corequisite: CLRE 254. Prerequisites: CLRE 253, admission to the MAS in Clinical Research Program, or consent of department.

The objective of the course is to provide students instruction in contemporary methods and statistical analyses in behavioral science research. Will teach hands-on practical skills in developing and validating assessment measures, designing clinical trials in behavioral sciences, dissemination and implementation methods, and meta-analysis. Prerequisites: access to SPSS statistical software, MAS Clinical Research program, or permission of department.

This experiential course builds on the knowledge gained in the core curriculum through hands-on lab and simulation-based exercises. Students will learn basic lab methods and communication skills pertinent to engaging subjects in clinical research. May be taken for credit four times. While students are required to take the course two times, the course would apply toward general elective requirements when taken a third and fourth time. Prerequisites: CLRE 250, CLRE 251, and admission to the MAS Clinical Research Program or consent of department.

Prerequisite of 2 other courses

Students conduct a systemic review of the literature leading to the background and hypothesis/specific aim of their ISP, culminating in a written paper and class presentation for faculty and peer feedback. Mentorship and career development topics will be discussed by a series of guest speakers. Prerequisites: admission to the MAS Clinical Research Program or consent of department.

Students present a research-in-progress talk related to their ongoing ISP work. They will submit an institutional review board (IRB) proposal/report including a master’s protocol that would be submitted to the IRB. This will consist of the data management plans including case report forms, data analysis plans, sample size calculations, and budget. Mentorship and career development topics will be discussed by guest speakers from academia and industry. Prerequisites: CLRE 295A and admission to the MAS Clinical Research Program or consent of department.

Students conduct a high-level clinical research project that integrates what they have learned in their formal course work. The ISP will include their course work in CLRE 295A-B and be presented as a final report that includes a complete description of the project including the study manual, study results, statistical analysis, and a discussion of the findings. Students will make an oral presentation of their ISP to their three-member ISP committee comprised of faculty and industry advisers. The ISP is an independent, creative, and scholarly activity, and students will be graded on their written and oral presentations. Prerequisites: CLRE 295A and admission to the MAS Clinical Research Program or consent of instructor.

The ISP is the cornerstone of the MAS program. Students will be involved in a high-level clinical research project that integrates what they have learned in their formal course work. The ISP will be an independent and creative scholarly activity in an area related to one or more of the topics covered in the formal curriculum. Students’ work will be evaluated by a committee of faculty and may also include industry advisors when appropriate. Prerequisites: admission to the MAS in Clinical Research Program or consent of department.