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BIOM 640: Introduction to Clinical Research

2 semester credit, REQUIRED

The Introduction to Clinical Research will be essential in bringing all new trainees to the same level. The main objective of the course is to educate trainees in the essential aspects of clinical research and the basic processes of building patient-oriented research studies. This course explores the basic concepts of clinical research, starting with the history of fundamental studies and the researchers that have contributed to the field. In addition, this course will include the fundamentals of study conception (hypothesis), design (approach), and conduct (implementation) of clinical research with an emphasis on different clinical settings and analyses. In this course, trainees will:

  • acquire the skills for designing and interpreting clinical research;
  • produce a complete concise draft of a research protocol;
  • help others in the class to develop these skills and protocols;
  • provide feedback that will improve the workshop and its materials; and
  • in time, contribute to the field by teaching these skills to others.

Management, ethics, funding, publications, and regulatory aspects will also be discussed. A brief description of different bioanalytical methods, bioinformatics and genetics will be presented. The fundamentals of biostatistical analysis as applied to clinical research will also be addressed to bring all trainees up to baseline. Topics will include: measures of central tendency and dispersion; basic probability concepts; probability distributions; sampling; estimation; hypothesis testing; student’s t-test; analysis of variance; regression and correlation; the Chi-square test; and non-parametric and distribution-free statistics. Textbooks: Designing Clinical Research, 2nd Ed., (Hulley et al, Lippincott, Williams and Wilkins, 2001; Biostatistical Analysis, 2nd Edition (Zar JH, Prentice-Hall Resources: Clinical Researchers).


Professor: Dr. Rosanne C. Harrigan

Course Number: 640

Course Title: Introduction to Clinical Research and Informatics Applications in Research

Course Credit: 2 credits

Prerequisite: MD, PhD, or equivalent dotoral degree or permission of instructor

Placement in Curriculum: Spring Semester (first semester)

Course Description:
This course provides instruction in developing a clinical research question and creating a concise protocol that includes a literature review, study design, subject recruitment and sampling, instruments and other measurement approaches, sample size, consent form, budget and timetable and use of bioinformatics. Each trainee reviews and supports the work of colleagues. The course closely follows the textbook Designing Clinical Research, by S. Hulley.

Course Objectives: In this course, students will:

  • acquire the skills for designing and interpreting clinical research, including appropriate informatics;
  • produce a complete concise draft of a research protocol;
  • help others in the class to develop these skills and protocols;
  • provide feedback that will improve the course and its materials; and in time, contribute to the field by teaching these skills to others.

Learning Outcomes: At the conclusion of the course students will be able to:

  • use of informatics to design and interpret clinical research
  • prepare a first draft of a research proposal
  • collaborate with other researchers on protocol development
  • possess the skills to contribute to the field by teaching basic research skills to others

Topical Outline:

  1. General Sessions
  2. Getting Started: the anatomy of clinical research
  3. Conceiving the Research Question
  4. Choosing the Study Subjects: Specification, Sampling, and Recruitment
  5. Planning the Measurements: Precision, Accuracy and Informatics
  6. Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles
  7. Estimating Sample Size and Power: The Nitty-gritty
  8. Designing an Observational Study: Cohort Studies
  9. Designing an Observational Study: Cross-sectional and Case-control Studies
  10. Enhancing Causal Inference in Observational Studies
  11. Designing an Experiment: Clinical Trials I
  12. Designing an Experiment: Clinical Trials II
  13. Designing Studies of Medical Tests
  14. Research Using Existing Data: Secondary Data Analysis, Ancillary Studies, and Systematic Reviews and Informatics
  15. Addressing Ethical Issues
  16. Designing Questionnaires and Data Collection Instruments
  17. Data Management and Informatics
  18. Implementing the Study: Pretesting, Quality Control, and Protocol Revisions
  19. Community and International Studies
  20. Writing and Funding a Research Proposal

Teaching Methods

  • Discussions of interest emerging from the previous week
  • Illustrations of selected aspects of the readings from current week
  • Review of assigned protocol assignments
  • Weekly Exercises
  • Critique of Protocols
  • Submission of protocol by email

Required Texts:
Designing Clinical Research, 2nd Ed., (Hulley et al, Lippincott, Williams and Wilkins, 2001;
Biostatistical Analysis, 2nd Edition (Zar JH, Prentice-Hall Resources: Clinical Researchers).

Learning Experiences:
Lecture, discussion, critique, literature searchers and analysis, protocol development

Evaluation:

Critiques of protocols 10%
Submission of completed protocol 75%
Exercises 10%
Evaluation 5%