Clinical Research Studies
A clinical research study is a medical and scientific study which aims is to gain new knowledge about the mechanisms of disease and/or to study new treatments. Some studies are carried out with occasional clinic visits and others may require a stay in the hospital.
Patients participate so that they can help others by contributing to medical research; they assist in the advancement of knowledge about causes, progress, and treatment of disease, and in the advancement of knowledge that will promote health. Participation may also allows them to gain access to new experimental treatments before they are widely available.
The Principal Investigator (PI) is the research physician who oversees and directs the study and who assumes ultimate responsibility for the research.
In many studies, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment or a placebo. A placebo is an inactive substance or sham procedure with no treatment value, which is used to determine the effectiveness of the proposed medicinal substance or procedure.
Healthy volunteers help advance knowledge about diseases by helping researchers compare how healthy people differ from those who have a specific disease.
After initial screening by phone or email, potential volunteers usually have a preliminary screening visit to discuss the details of the study and to determine their eligibility. The nurse or physician will explain the purpose of the study, the data that will be collected, and collection methods. Often studies require following very organized routines to gather information. If an in-patient stay is required, volunteers will stay at Rockefeller University Hospital, where all rooms are private with bathrooms, TV, VCR, and phones allowing free local calls. Volunteers may bring their own computer with fax/modem for use in the room.