| What is a clinical trial? |
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A clinical trial (also clinical research) is a research study in human
volunteers to answer specific health questions. Carefully conducted clinical
trials are the fastest and safest way to find treatments that work in people
and ways to improve health. Interventional trials determine whether
experimental treatments or new ways of using known therapies are safe and
effective under controlled environments. Observational trials address health
issues in large groups of people or populations in natural settings.
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. 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 are the benefits and risks of participating in a clinical trial? Benefits Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
Risks There are risks to clinical trials.
What should people consider before participating in a trial? People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
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