Lecture Series: Clinical Research Methods
The annual Clinical Research 101: Fundamentals of Clinical Research Methods lecture series provides the fundamentals of clinical research methods for graduate students, residents, fellows and faculty.
Created in response to requests from training program directors, the series has been offered annually since 2004 with more than 600 participants to date. This popular and comprehensive series covers such topics as:
- Study design
- Biostatistics
- Comparative effectiveness research
- Research ethics
- Evaluation of diagnostic testing
- Cost-effectiveness analysis
- Genetic/genomic issues
Who Can Participate?
The annual Lecture Series attracts scholars and researchers from throughout Einstein as well as from other institutions. Typical participants include:
- Graduate (Ph.D.) Students interested in clinical/translational research, especially those considering the Ph.D. in Clinical Investigation
- Medical (M.D.) Students interested in clinical research, especially those considering applying for the M.D./M.S. track
- Residents And Fellows enrolled in Einstein affiliated GME programs whose program directors seek to provide didactic instruction in research methods
- Faculty interested in learning more about clinical research, especially those considering applying for the Clinical Research Training Program (CRTP) or seeking Continuing Medical Education (CME) credit
Seminar Course: Design and Conduct of Clinical Research
Course Description
This seminar course aims to introduce students to clinical research with a focus on epidemiology and study design. The course uses an introductory clinical research text, along with a critical assessment of papers from the scientific (clinical and epidemiologic) literature, in order to learn about study designs: their strengths and weaknesses and how such studies are conducted. Topics to be covered include: basic epidemiology, measures of association, basic statistics, cohort studies, case control studies, clinical trials, causal inference, and research ethics.
Course Overview
The course will be taught by a team of 2 faculty members.Some classes will involve computer-based exercises, and will require students to bring their laptops to class. All classes will require advance preparation and active participation.
Learning Objectives
At the end of the course, students will be able to:
- Describe what makes a good research question.
- List the major elements of a cohort (and retrospective cohort) study.
Critique a case-control study, and describe alternative designs.
- Explain the advantages and disadvantages of specific study designs for specific research questions.
- Interpret a randomized trial.
Explain the role of significance testing in clinical research.
- Interpret the major measures of association used in epidemiologic research.
- Describe the estimates and assumptions involved in sample size determination, and perform simple calculations.
- Identify ethical challenges in clinical investigation, and propose solutions to those challenges.
- Distinguish between associations and causal connections in etiologic research.
Course Requirements & Grading
The course will be graded “Honors/Pass/Fail”. (As per graduate school regulations, a grade of “incomplete” may be allowed if absolutely necessary at the discretion of the Professors) We plan to use a criterion standard for grading: i.e., Honors > 90%, Pass 65-90%, Fail 65%. However, we reserve the right to ‘curve’ these cut-points if necessary.
The grade will be determined using the following formula:
- Final examination (in-class; short-answer/short-essay): 70%
- Class participation as determined by faculty (preparation, contribution to discussion): 30%
Final Exam
There will be an in-class final exam.
Angel
Angel will be used as the main platform for posting course materials and communicating with students.
Textbooks
Designing Clinical Research, Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB., 4th Ed. Lippincott Williams & Wilkins; Philadelphia: 2013. ISBN-10: 1608318044 | ISBN-13: 978-1608318049