Introduction to Clinical and Translational Research - Session 1

This course introduces the mission and processes of Clinical and Translational Research (CTR). It demonstrates approaches to formulating and writing research questions and hypotheses appropriate to CTR. Online video lectures prepare participants for the course sessions.

About this Resource

CTR is the branch of health research that seeks to bridge the gap between bench researchers who conduct basic science and clinicians seeking to treat people and populations. To speed the pace of CTR, the NIH has galvanized the field through establishment of the Clinical Translational Science Award.

In Part 1 of the video lectures that accompany "Introduction to Clinical and Translational Research, Session 1," a lecturer summarizes the history and rise of CTR in recent years, and introduce its key concepts. He reviews the obstacles that make translational research difficult, and the basic processes and architecture of CTR studies. Emphasis is given to CTR's various goals, including the improved use of bioinformatics and high dimensional data in research, and the development of Precision Medicine, (sometimes known as personalized medicine.)

Part 2 of the video lectures focuses on the importance of forming research questions and hypotheses appropriate to CTR inquiry. The lecturer outlines the types of health phenomena CTR is most concerned with, including disease/health mechanisms and mediators, diagnoses, and interventions. She reviews the nature of CTR research questions, and provides tools to help new investigators construct compelling hypotheses that will contribute to success in research, grant applications and article submissions.

Course Syllabus

  • What is Clinical and Translational Research?
  • Understanding the Stages of CTR
  • The Role of CTR in Precision Medicine
  • Using High Dimension Data (Bioinformatics)
  • Multidisciplinary and Team Research in CTR
  • Outcomes and Comparative Effectiveness Research
  • Formulating Clinical Translational Research Questions and Hypotheses
  • Common Reasons Why Papers are Rejected for Publication
  • Where Do You Find the Hypotheses in Published Article?

Recommended background

Please complete the following prior to attending the annual short course, "Introduction to Clinical and Translational Research, Session 1:”

  • Pre-test on Clinical Translational Research
  • View the two-part video resource
  • Participant Break-out Session Guide
  • Read the four articles listed below

Suggested Readings

  • Liu R1, Wang X, Chen GY, Dalerba P, Gurney A, Hoey T, Sherlock G, Lewicki J, Shedden K, Clarke MF. The prognostic role of a gene signature from tumorigenic breast-cancer cells. N Engl J Med. 2007 Jan 18;356(3):217-26.
  • Slamon DJ1, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92.
  • Pritchard KI, Shepherd LE, O'Malley FP, Andrulis IL, Tu D, Bramwell VH, Levine MN; National Cancer Institute of Canada Clinical Trials Group. HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med. 2006 May 18;354(20):2103-11.
  • Stark A1, Kucera G, Lu M, Claud S, Griggs J. Influence of health insurance status on inclusion of HER-2/neu testing in the diagnostic workup of breast cancer patients. Int J Qual Health Care. 2004 Dec;16(6):517-21.


Yes. Participants who complete the course receive a Certificate. They must watch the videos and attend the in-person session.

No. In addition to K Scholars, this course is open to faculty, clinicians, community health workers, fellows, post-docs, TL1 and F trainees, as well as medical, OT/PT, pharmacy and other students who intend to conduct clinical and translational research.


Jonathan Samet, MD, MS
Former Director, SC CTSI Workforce Development; Currently, Dean and Professor Colorado School of Public Health, University of Colorado, Denver

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.