Clinical Trials Q&A

What is a clinical trial?

Although there are many definitions of clinical trials, they are generally
considered to be biomedical or health-related research studies in human beings
that follow a pre-defined protocol. BlackDoctor.org includes information on both
interventional and observational types of studies. Interventional studies are
those in which the research subjects are assigned by the investigator to a
treatment or other intervention, and their outcomes are measured. Observational
studies are those in which individuals are observed and their outcomes are
measured by the investigators.

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.

Who can participate in a clinical
trial?

All clinical trials have guidelines about who can participate. Using
inclusion/exclusion criteria is an important principle of medical research that
helps to produce reliable results. The factors that allow someone to participate
in a clinical trial are called “inclusion criteria” and those that disallow
someone from participating are called “exclusion criteria”. These criteria are
based on such factors as age, gender, the type and stage of a disease, previous
treatment history, and other medical conditions. Before joining a clinical
trial, a participant must qualify for the study. Some research studies seek
participants with illnesses or conditions to be studied in the clinical trial,
while others need healthy participants. It is important to note that inclusion
and exclusion criteria are not used to reject people personally. Instead, the
criteria are used to identify appropriate participants and keep them safe. The
criteria help ensure that researchers will be able to answer the questions they
plan to study.

What happens during a clinical
trial?

The clinical trial process depends on the kind of trial being conducted (See
What are the different types of clinical trials?) The clinical trial team
includes doctors and nurses as well as social workers and other health care
professionals. They check the health of the participant at the beginning of the
trial, give specific instructions for participating in the trial, monitor the
participant carefully during the trial, and stay in touch 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. For all types of
trials, the participant works with a research team. Clinical trial participation
is most successful when the protocol is carefully followed and there is frequent
contact with the research staff.

What is informed consent?