About

Background

Since the days of Hippocrates and Aesculapius those privileged to be entrusted with the care of the sick have recognized that their profession demands adherence to a rigorous ethical code of behavior that puts the patient’s welfare first and that emphasizes as a first principle, primum non nocere (first, do no harm!). As one approaches the subject of clinical investigation, it is clear that the basic ethical code of the physician is still operative. When one enrolls another human being into clinical research projects, however, even higher standards of conduct are mandatory.

These higher standards are upheld by three fundamental principles:

Respect for persons: Individuals must be treated as autonomous agents, with special care taken to provide “vulnerable individuals and populations” with adequate protection so that their autonomy is protected.

Beneficence: Secure the well being of the individual; and develop information that will result in the advancement of medical science for society in the future.

Justice: Individuals must be treated fairly and that each person and each segment of society share equally the benefits and the burdens of an intervention.

The profound significance of these three principles to the work of the clinical investigator as well as the impact his/her work has on humankind is emphasized by many illustrative case examples and cogent instruction in this informative and timely lecture series.

We are grateful to Michael F. Murphy, MD, PhD, Chief Medical Officer and Senior Vice President of Drug Discovery and Development for Neurogenetics, Inc. for generously offering this course each year to the Fellows of the Clinical Investigator Training Program (CITP). (The CITP is a two-year training program within the Harvard-MIT Division of Health Sciences and Technology.) Dr. Murphy, who is also an exclusive and unrestricted consultant for UnitedHealth Group and i3 Research is one of the most gifted clinicians and teachers in this field. We are privileged and pleased to share his expertise with the international community of clinical investigators.

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Lectures

The lectures are divided into small segments of approx. 5 minutes in length and cover the following topics:

  • The Drug Development Process in Overview
    • Phases of Drug Development
    • Physician/Investigator in Industry Sponsored Research
    • Preclinical/Clinical Interface
    • Clinical/Commercial Interface
    • Role of Regulatory Science
    • Subject Protection Issues
    • Trends in Clinical Research
  • Clinical Trial Objectives, Designs, and Classifications
    • General Protocol Considerations
    • Study Design Options
    • Common Debates( historical controls, run-in periods, and problems with placebo)
  • Analysis and Interpretation
    • Variance
    • Attrition
    • Center Effects
    • Covariates
    • Multiple Comparison Procedures
    • Survival Analyses
    • Interpretation of Results

System Requirements:

The lectures for this web course are provided using a free plug-in called "Flash." If your computer does not have Flash version 7, please go to Macromedia's Web Site to download.

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Privacy

In visiting the website you may be asked to supply certain personally identifying information and to voluntarily supply additional information. If you choose to provide your name, e-mail address, postal address, phone number, organization or any other identifying information, it will be used only to provide you with the information and course access that you have requested, or in general statistical analysis of the use of the website. HST, Harvard and MIT will not sell or rent any personally identifying information obtained through these websites to any other organization and will never willfully disclose any personally identifying information about users to any third party without the user's explicit permission.

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Clinical Investigator Training Program

The Clinical Investigator Training Program is a cooperative effort between Beth Israel Deaconess Medical Center , the Harvard-MIT Division of Health Sciences and Technology, CareGroup, and Pfizer Inc. Established in 1993, the two-year fellowship program trains physicians from various clinical disciplines in the techniques and processes used in patient-oriented research. The program’s unique curriculum combines hands-on experience in clinical investigation and didactic course work in:

  • Computational and statistical sciences
  • Biomedical ethics
  • Principles of clinical pharmacology
  • In vitro and in vivo measurement techniques
  • Different aspects of the drug development process

Upon completion of the two-year program, fellows acquire a strong foundation in patient-oriented research. Graduates of the program are equipped to apply the latest research tools to clinically relevant areas of investigation and are prepared for careers in patient-oriented research in academic medicine, industry, and regulatory affairs.

CITP is funded through an unrestricted educational grant from Pfizer Inc. Pfizer also contributes faculty who teach in the program’s didactic curriculum. Students in this program are selected from a competitive pool of physicians from the Harvard Medical School training programs.

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