Clinical Trial Agreements

New Resource: Clinical Trial Decision Tree 

Operational Definition Of A Clinical Trial

From the Data and Safety Monitoring (DSM) Guidlines for Clinical Trials 2003- University of Chicago, the Division of the Biological Sciences and the Pritzker School of Medicine.

A clinical trial is operationally defined as a prospective study involving human subjects that is designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions. Such studies may include drugs, treatments, devices, or behavioral or nutritional strategies.

In the area of molecular or imaging diagnostics, a study is a clinical trial if it uses the information from the diagnostic test in a manner that somehow affects medical decision-making for the study subject. In this way the information from the diagnostic test may have an impact on some aspect of outcome, and assessment of this outcome may be a key goal of the trial. By contrast, studies that do not use information from the diagnostic test in any manner that can affect the outcome of study subjects, but whose objective is only gathering data on the characteristics of a new diagnostic approach, are not clinical trials and are not covered by this DSM policy, unless performing the diagnostic test itself imposes some risk on study subjects.

Behavioral clinical trials include studies of interventions with the goals to increase behaviors (e.g., cancer screening, physical activity, fruits and vegetable intake), eliminate or reduce behaviors (e.g., smoking, sun exposure) and /or improve coping and quality of life or reduce the negative sequelae of treatment. Observational studies and those that do not test interventions are not considered clinical trials.

Clinical trials are generally conducted in hospital space, while clinical research is generally conducted in laboratory space.

Clinical research is patient-oriented research. This type of research involves a particular person or group of people or uses materials from humans. This research can include: studies of mechanisms of human disease; studies of therapies for disease; studies to develop new technology related to disease.

The issue really boils down to whether research is conducted in clinical space with hospital resources or University space with University resources. Most clinical research involving human subjects takes place in and with the latter.