Introduction to Clinical Investigation

Introduction to Clinical Investigation Introduction to Clinical Investigation is a five-day course designed to give fellows and junior faculty a solid foundation in the principles and methods of clinical investigation. This course is also a gateway to additional specialized training, mentoring, and consultative opportunities for clinical investigators available through Harvard Catalyst.

Introduction to Clinical Investigation

The Harvard Catalyst Postgraduate Education Program is committed to training clinical investigators through a range of educational offerings, with the Introduction to Clinical Investigation course serving as the first level. Subsequent educational experiences will provide advanced training, including master's degrees.

The objective of the Harvard Catalyst Introduction to Clinical Investigation course is to ensure that all fellows and junior faculty have an opportunity to gain the skills necessary to embark on a career in clinical research. As some Harvard Catalyst-affiliated institutions may already have similar introductory courses, department chairs or division chiefs will determine whether a particular individual would benefit from the curriculum described below.

Course Directors:

Elliott Antman, MD
Professor of Medicine
Brigham & Women’s Hospital
Director, Harvard Catalyst Postgraduate Education Program in Clinical & Translational Science

James Ware, PhD
Frederick Mosteller Professor of Biostatistics
Harvard School of Public Health
Associate Director, Harvard Catalyst Postgraduate Education Program in Clinical & Translational Science

Course Information

Dates and Location

  • November 2-6, 2009, Norton's Woods Conference Center at the American Academy of Arts and Sciences. Please note that the November session is closed for enrollment
  • March 1-5, 2010, location to be determined. Enrollment for this session will open in early December.

Outline

Day 1 Lectures: Principles of Biostatistics and Study Design
  Workshops: Proof of Concept Studies, Methods for Clinical Trials Designed to Impact the Practice of Medicine
Day 2 Lectures: Ethics of Human Investigation, Regulatory Knowledge (Drugs, Devices, Biologics), Good Clinical Practice in Research
  Workshops: Responsible Conduct of Research, Research Ethics
Day 3 Lectures: Behavioral/Social Science Research, Database Research, Community-Based Participatory Research, Cost Effectiveness and Comparative Effectiveness
  Workshops: Design, Analysis, and Interpretation of Epidemiologic Studies and Health Care Delivery Research
Day 4 Lectures: Additional "research toolbox" skills (e.g., clinical pharmacology, genetics, imaging, informatics)
  Workshops: Mentoring
Day 5 Lectures and Interactive Presentations: Communication arts, including obtaining informed consent, delivering oral scientific presentations, writing a scientific paper, writing a grant application
  Informational Lecture: Navigating the research resources in the extended Harvard community

Admission Requirements

  • A dedicated interest in clinical and translational research
  • Endorsement by the applicant's department chair or division chief of his/her interest in clinical investigation and approval for time away from clinical responsibilities to attend the five-day course
  • An MD or PhD degree or equivalent (with explicit involvement in clinical research)

Tuition

Free of charge. Harvard Catalyst is sponsoring the course as part of its Postgraduate Education Program.

Application Process

The course's next session will take place March 1-5, 2010. Enrollment for this session will open in early December 2009.

Please watch for subsequent announcements with additional details.

Course Completion

Upon completion, participants will receive a certificate of course participation designating them as Level I Harvard Catalyst Investigators.

Relationship to Other Training Opportunities Available Through Harvard Catalyst

This introductory course is designed to stimulate interest in clinical and translational research and encourage further study in one of the following:

Questions?

Please contact Program Coordinator Michelle Foley (E-Mail or 617-432-7809).