What is a clinical trial? A clinical trial is a research study with human volunteers that tests the efficacy, safety, and dosing of investigational drugs and devices.

 

Why participate in a clinical trial? Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Clinical trials are typically free of charge and do not require medical insurance to participate.

 

What happens during a clinical trial? The clinical trial team includes doctors, nurses, and research coordinators. Research coordinators check the health of the study participant at the beginning of the trial.  They also give specific instructions for participating in the trial, monitor the participant carefully during the trial and stay in touch during and after the trial is completed.

 

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff. This also ensures that a participant's health and progress is closely monitored while they are on a study drug.

 

How is the safety of the participant protected? The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, almost all clinical research is federally regulated with built in safeguards to protect participants. The trial follows a carefully constructed and controlled protocol which is a study plan detailing what researchers will do in the study. At the completion of a clinical trial (or sometimes as it progresses), researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies, such as the FDA. Individual participants' names are not mentioned in these reports. Data is referred to by a study number and/or initials.

 

What is an Institutional Review Board? As in any medical research facility, an Institutional Review Board (IRB) must review and approve every new study before any study can begin. The IRB is made up of medical specialists, statisticians, nurses, social workers, medical ethicists, and members of the community. The IRB's responsibility is to ensure that the rights of persons participating in research studies are upheld. These IRBs review the protocol and the informed consent form to make sure that any risks are minimized to the greatest extent possible and that all risks are explained before a person agrees to participate.

 

What does informed consent mean? Before entering into a study, it is important that the research participant fully understands the study and what involvement in the study will entail.  Research staff members will help by providing you with an informed consent statement, which has detailed information about the study, including the length of the study, the number of visits required, and medical procedures and medications included. The informed consent details what compensation will be given as well. It also provides expected outcomes, potential benefits, and possible risks.

 

Research staff will review the informed consent statement with you and answer your questions. If you decide to participate after reviewing the statement and talking with staff and family members, you will need to sign the informed consent statement. Your signature indicates that you understand the study and agree to partiicpate voluntarily.

 

Will I be paid to participate in a clinical trial? The majority of our clinical trials offer compensation for time/travel and participation.