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Patient safety

Patient Safety in clinical trials

There are certain rules that help ensure the safety and ethics of clinical trials. Especially in the case of a child participating in a clinical trial, the rules are extra strict. Prior to enrolling the study, your doctor will discuss elements of the trial such as: the length of the study, the number and interval of visits required, the lab work and other tests or questionnaires required during the study. Any study related physical exam or outcome measures will be described.

Below, more information on:

  • Giving consent & assent
  • Randomization
  • Trial safety
  • Trial timeline

Giving consent & assent

Your principal investigator will talk you through the consent process. This can be done by telephone call or in person. In this conversation, you will receive more information about the trial itself and alternative options, what kind of tests your child has to do, and the duration and intensity of the clinical trial. Possible risks and benefits are also discussed. Make sure you receive this information in a language you can understand, and discuss this later with another peer or your patient organization.

After this conversation, you will receive an informed consent form. This contains all the information that you just discussed and describes which kind of patient data will be collected and how this medical record will be stored. You can always ask additional questions to the principal investigators, members of the research team or someone of your patient organization. Sometimes, this consent form is dynamic, meaning that you always decide how your medical information should be used.

If you have read this document through and agree with this, you sign the form. Although this is final, you are free to withdraw from the clinical trial at any time. The study consent (for a parent, if participant will be under age 18) and assent (for participants age 7 -17) will be described, mailed and later discussed prior to enrolment.

Legally, children are not able to give consent until they turn 18. Instead, they are asked for their assent: they agree to take part. Children must be old enough to understand the trial and what they have to do. They will receive this information from the research team. Additionally, this app is an easy-going way to learn what is going to happen when a child participates in a clinical trial.

Randomization

Earlier on, we talked about the different types of groups.

Trial Safety

Before the clinical trial starts, experts will review the process to make ensure patient safety.

In most cases, there is a board that will review protocols before the study can begin. The board closely monitors the progress of the trial and its outcome. This board is capable to change the protocol, or even stop the trial for the sake of the patients’ safety.

In Europe, the European Medicines Agency (EMA) approves new drugs before they can be sold. The EMA also protects people in research studies  and ensures the data from the trial is used correctly. The EMA can decide to remove researchers from conducting trials when the rules are not followed. In the United States, this done by the Food and Drug Administration (FDA).

Trial Timeline

Most of the time, clinical trials run from the beginning to end. However, an extension can be asked if […]

A clinical trial can be stopped early for several reasons:

  • A new study answers the research question
  • Side effects are too severe, so the harms outweigh the benefits
  • There is clear evidence the drug is effective, trial can be stopped to make treatment widely available
  • There are not enough patients recruited to conduct the study

After the trial has ended, there are several options that are described here.