Frequently Asked Questions about Clinical Trials

What is a clinical trial?
A clinical trial is a research study in human volunteers designed to test the efficacy and safety of investigational drugs and/or devices. Carefully conducted clinical trials are the fastest and safest way to ¬find treatments that work in people and ways to improve health.

Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to investigational treatments before they are made widely available and help others by contributing to medical research. Clinical trials are typically free of charge and sometimes offer compensation to participants.

What happens during a clinical trial?
The clinical trial team includes doctors, nurses, research coordinators, as well as other healthcare professionals. They check the health of the participants at the beginning of the trial, give specifi¬c instructions for participation, monitor the participant’s health carefully during the trial and stay in touch after the trial is completed. Some clinical trials involve more tests and more frequent 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 throughout a study.

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, medical journals and to variousgovernment 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 the 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 study protocol and the informed consent form to make sure that any risks to participants are minimized to the greatest extent possible and that all risks are adequately explained to the research subject before obtaining consent to participate.

What does informed consent mean?
Informed consent is a legal agreement documenting a study participant’s full understanding of the clinical trial’s associated procedures, expected outcomes, potential risks and benefits.

It is also the continuous process of providing study information to participants. Research staff will provide the patient with an informed consent statement, containing detailed information about the study, including the length of the study, the number of doctor’s visits required and medical procedures and medications and/or devices involved. It also provides expected outcomes, potential benefits and possible risks associated with participation. The informed consent also details what compensation, if any, will be given to participants.

Research staff will review the informed consent statement with the participant and answer all questions. If the participant decides to participate after reviewing the statement and discussing it with staff and family members, they will need to sign the informed consent statement. Although the informed consent is a legal document, it is not a contract and the participant may withdraw from the trial at any time. The participant’s signature indicates that they understand the study and agree to participate voluntarily in the study. Signing the informed consent document is a necessary part of the clinical trial process.