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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.

When thinking about participating in a clinical trial, you will face the issue of how to cover the costs of care. Even if you have health insurance, your plan may not cover all of the costs related to receiving treatment in a clinical trial. This is because some health insurance companies define clinical trials as "experimental." There are two types of costs associated with a clinical trial, the patient care costs and the research costs. The routine care costs for the patient, like doctor visits and scans, are those related to treating your disease, whether you are in a trial or receiving standard therapy. These costs are often covered by health insurance, whereas extra costs are not always covered. Research costs are those related to conducting the trial and those are often covered by the organization sponsoring the trial.

More information can also be found at ClinicalTrials.gov The U.S. National Institutes of Health has developed ClinicalTrials.gov to provide patients, family members and members of the public current information about clinical research studies. The database is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details.

Informed Consent

An essential component of initiating a clinical trial is to recruit study subjects following procedures using a signed document called "informed consent". Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants.

To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Locating Clinical Gene Therapy Trials

Depending on the kind of participants required, sponsors of clinical trials use various recruitment strategies, including patient databases, newspaper and radio advertisements, flyers, posters in places the patients might go (such as doctor's offices), and personal recruitment of patients by investigators. Volunteers with specific conditions or diseases have additional online resources to help them locate clinical trials. Patients may search in the clinical trial databases provided on Gene Therapy Net, but they can also search directly on ClinicalTrials.gov to locate trials using a registry run by the U.S. National Institutes of Health and National Library of Medicine.

Please note that many clinical trials will not accept participants who contact them directly to volunteer as it is believed this may bias the characteristics of the population being studied. Such trials typically recruit via networks of medical professionals who ask their individual patients to consider enrollment. A number of patients also travel to other countries for medical treatment. See for more information the section Medical Tourism.


Gene Therapy Net is not intended to replace or constitute the giving of medical treatments or advice. Gene Therapy Net will not answer any questions related to treatments, medical advice or participation in clinical trials.

Your doctor may be an excellent resource to help identify clinical trials for a particular disease.

Clinical Trials Books