Who is Eligible to Participate in a Clinical Trial?
Each study has its own guidelines for who can participate, called eligibility criteria. Generally, participants in a study have things in common, such as the type and stage of cancer, age, gender, and/or previous treatments. The eligibility criteria are included in the study plan. To find out if you are eligible for a particular study, talk to your doctor. The principal investigator (usually the physician who is in charge of the clinical trial) prepares a plan for the study, called a protocol. The protocol explains, specifically, what the study will do, how it will be carried out, and why each part of the study is necessary.
Eligibility criteria are unique to each clinical trial, as explained by the National Cancer Institute: “Each study has its own guidelines for who can participate, called eligibility criteria. To ensure the strongest results, researchers want study participants to be alike in key ways. Examples of eligibility criteria for a treatment trial might be a particular type and stage of cancer, age, gender, or previous treatments. The eligibility criteria are included in the study plan. To find out if you are eligible for a particular study, talk to your doctor or the doctor or nurse in charge of enrolling patients for the study.
Each study has its own set of eligibility criteria, or inclusion/exclusion criteria; these criteria state who can and cannot participate in a particular study. Generally, participants within a study are alike in significant ways such as type of disease or illness, age, gender, previous or current treatments, or other medical conditions. The criteria for a particular study help define the appropriate population, as well as keep people who are not appropriate for the treatment safe. While some clinical trials enroll people with a specific illness or disease, others enroll healthy participants. To find out if you are eligible for a particular study, contact the project coordinator or nurse in charge of participant enrollment.
Each individual trial is an attempt to answer a very specific research question, therefore each trial has certain prerequisites and requirements concerning health, medication, age and other personal factors. A participant must meet all requirements to be an eligible volunteer. The researchers conducting the trial will be able to provide specific information as per that particular study. Why participate in a clinical trial? Mental health is an extremely sensitive and personal issue. Participating in a trial will not only help you and possibly improve your health with a new treatment, it will help thousands of others who may have a similar problem. New drugs or procedures may reduce pain and even cure your illness. Participating in a clinical trial will give you the satisfaction that comes from being part of a scientific research study. There are people hoping every day for a breakthrough treatment that will make coping with an illness easier, or that will possibly even eliminate it comp
Every clinical trial has specific criteria for participants in order to maximize the effectiveness of the study and obtain the most reliable results. There are “inclusion criteria” which allow someone to participate in a clinical trial and “exclusion criteria” which exclude someone from participating in a clinical trial. A study may require healthy participants or participants who are affected by the particular disease being targeted in the trial. The stage of illness, previous treatment history, gender, age and other factors can determine ones eligibility.
