Considering a clinical trial
The decision to enroll your child in a clinical trial is a personal one that should be made in partnership with your child's doctor. For many families living with Duchenne, clinical trials offer a chance to receive investigational drugs, but there are many factors that need to be considered.
A clinical trial that is well-planned and well-conducted potentially offers participants the chance to:
- Have access to investigational treatments that are being studied in research (investigational drugs)
- Receive regular, careful medical attention from a team of healthcare professionals
- Be part of research that may result in advancing the understanding of a disease or the approval of an investigational treatment
Once you and your child's doctor have determined that a clinical trial is the right step for your family, you’ll need to find a trial that is a good match.
Each clinical study has "eligibility criteria" that must be met in order to participate. These factors determine which individuals can participate, and are different for every clinical trial. These may include:
Type and stage
Medications or treatments
participants are using
or have used
Other criteria, such as a person's
health status or ability to do the
tasks needed in a study
Before your child can participate in a trial, he must go through a screening process to see if he meets these criteria. The screening process could include tests and interviews. Not everyone who applies for a clinical trial will be selected to participate.
If your child meets the eligibility criteria, the clinical trial staff will start the informed consent process. Informed consent helps you and your child decide whether or not you want to be part of a particular clinical trial.
Informed consent explains the following:
- How the study will be conducted
- Specific participant requirements
- Risks and benefits of participation
- Study duration
- Cost to you, if any
- Payment to you, if any
- Names and phone numbers of key contacts
If you and your child decide together that you do want to be part of the trial, you will sign the informed consent document to indicate that you understand what the study involves, and its risks and benefits. Informed consent does not mean you have to stay in the study; you can ask to leave the study at any time.