Clinical Investigation: Program Overview

The Board of Trustees has voted to close the Clinical Investigation program and is no longer accepting students. The program will close in 2010.

The explosion of scientific advances in genetics and other areas leading to new medical treatments in recent years has given rise to a vast and complex field of patient-oriented clinical research known as Clinical Investigation.

Clinical Investigation involves a number of areas of clinical research necessary to the development of drugs, medical devices, radiological products, and biologicals for the treatment, prevention, or diagnosis of a disease or condition in humans. Included among these are:

• Translational Research - defining normal physiology and disease mechanisms
• Clinical Trials - testing new drugs, devices, radiological products, and biologicals for efficacy in order to bring new products to market 
• Outcomes Research - determining the effectiveness of established therapeutic approaches

All of this research involves the study of human beings or human samples (if analyzed in correlation with a patient’s entire clinical condition). The field of Clinical Investigation encompasses all the professions needed to design, implement, manage, analyze, and govern this research.

For those interested in pursuing one of the wide array of professional roles needed to support this burgeoning field, the MGH Institute offers two graduate-level curricula:

Comprehensive and innovative in both its content and educational approach, our program offers a parallel instructional format that includes classroom and online options for many of its courses. Some courses are available as classroom courses and taught once a week on our Boston campus in the Charlestown Navy Yard. All courses for both the certificate and master’s programs are available online via dynamic, web-based software developed at the MGH Institute. These distance learning offerings blend optimal teaching methodologies with the flexibility of online academic study while opening the program to national candidates outside the Boston area.

Hands-on, human subject, clinical research experiences are a primary part of the master’s degree track, which offers closely-mentored, semester-long field placements in a variety of clinical research settings in a student's area of interest, both regionally and nationally.

The key areas of study essential to the development of a broadly-prepared, multi-skilled leader in clinical investigation are:

• The infrastructure of the clinical investigation process, including the multidisciplinary team responsibilities and rigorous scientific methods of patient-oriented clinical research and design as they apply to protocol review and feasibility, institutional review board direction, implementation of the trial, data management, and study completion.

• Statistical research-design considerations, including randomization and sample-size determination methods for analyzing statistical results from clinical investigations. 

• Ethical issues inherent in the design and conduct of patient-oriented clinical research, including the protection of human subjects, scientific fraud and misconduct, and emerging issues in clinical research ethics. 

• Principles of law governing patient-oriented clinical research, including contracts, negligence, product liability, as well as the regulatory framework of state and federal governments.