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Eligibility criteria and screening

Joining a clinical trial

You might have heard of a certain research project from your clinician, patient organization or healthcare professional. After some research, you decided you want to take part in the clinical trial study. This article explains whether your child fits the criteria to participate, and how to apply for a trial site when it’s in another country.

Eligibility criteria

for joining a clinical trial

Every clinical trial is required to have a protocol that explains what will be done before, during, and after the trial. Additional information and guidelines on who is able to join is included in so-called ‘eligibility criteria’. These are necessary to make sure the results are related to the drug being tested, instead of other factors. The eligibility criteria aim to give the trial the best possible chance of success and help protect volunteers and ensure that it is safe for them to participate.

For a detailed list of the criteria, you can visit the official clinical trial site.

If your child fits the eligibility criteria, researchers have to make sure there aren’t any additional health problems that could be made worse by the clinical trial. For this, a series of medical tests will be done to make sure the participant is fit for the trial. This is called a screening.

Screening

for joining a clinical trial

Once an interest in participating in the clinical trial is expressed, a screening visit will be scheduled to discuss and answer any questions prior to signing of study consent and/or assent and to complete all questionnaires, exams and lab work associated with the screening process. It is important to note that you and/or your child’s participation is totally voluntary and that you may, at any time, resign from the study without penalty and without compromising the right to receive the standard treatment. The cost of all the tests and examinations associated with clinical studies are covered and there are no trial-related fees.

Before enrolling in a clinical trial each participant will undertake a complex and rigorous screening process. There is no guarantee that a participant will be enrolled until the screening data has been evaluated. Similarly, many trials have a placebo control arm, which is a group of individuals who will not receive the treatment and will be the control group. There is therefore no guarantee that an individual in a clinical trial will actually receive the active treatment /intervention.

When you want to participate in a clinical trial that is outside your country, you can contact the site manager.