- What are clinical trials?
- How can my child become part of a clinical trial?
- List of current clinical trials
What are clinical trials?
Physicians use clinical research to learn about a new method for treating a medical disease or disorder. A clinical trial is a strictly controlled study in people. Clinical trials are approved and monitored by the UCSF Committee on Human Research.
Medical research studies include only those patients who choose to take part. Patients who are elegible for clinical studies will be counseled about the condition and made aware of all their options. It is important to understand that participation in a clinical study is completely voluntary and the decision to not participate in a study will not affect your child's care.
Benefits of participating in a clinical trial
Participation in a clinical trial has several potential benefits:
- Most importantly, it offers the chance to receive a new treatment that may not be available to the general public.
- It also will help you and researchers learn more about this condition.
- The knowledge gained from the study may help other patients in the future.
Disadvantages & Risks of participating in a clinical trial
There are also several potential risks of participating in a clinical research study:
Potential failure to improve your child's condition.
Your child may be selected to be in a group that gets a placebo or the standard treatment instead of the experimental treatment being studied.
Your child may also experience side effects or have an adverse reaction to your study treatment.
You may have to visit the doctor more often than you would for regular, standard care. The visits might involve having lab tests and procedures done.
How can I become part of a clinical trial?
If you decide that you might like your child to participate a clinical study, a trained member of the study team will explain all the details of the study to you. During this discussion you should ask as many questions as you would like to ensure your understand all the details of the study. If you agree to have your child enrolled in the study, the study team member will review and sign the consents with you and your family.
Following consent to enroll in the study, a study coordinator will schedule the procedure with the principle investigator. As prerequisites for the procedure, your child may be required to have a few medical tests. After the procedure, you may be asked to return to UCSF at various time points to have follow-up examinations by our study team.
Can my child leave a study once enrolled?
Yes. If you decide to be in a study now and you change your mind later, that is okay. You just have to tell the study doctor or the study staff as soon as you change your mind. They may ask you to come back for a final visit to check your health.
Will I have to pay to be in a clinical trial?
Financial arrangements are different for different research studies. Research costs, such as the cost of hiring personnel and managing data, are covered by the organization paying for the clinical study. Some research studies will pay you for joining the trial, but many will not pay you for participating. Some studies will reimburse some of your expenses, such as transportation, parking fees and childcare costs.
Costs for some studies, like clinical trials for drugs and implantable medical devices, may be charged to patients or their medical insurance. You should seek more information about the financial arrangements from the clinical research team and from your insurance provider.
List of current clinical trials
Magnetic Mini-Mover Trial Study
An experimental minimally invasive method to treat pectus excavatum.
We will be testing the safety and benefit of this procedure on patients with pectus excavatum who are between 8 years and 14 years of age and are otherwise healthy. Over the last two years, the Food and Drug Administration (FDA) extensively reviewed this proposed study with a particular emphasis on patient safety. The FDA has now approved use of the Mini-Magnetic Mover device (FDA Investigational Device Exemption # G050196/A002; 08/01/06).
For more information on the Magnetic Mini-Mover Procedure please visit the Magnetic Mini-Mover Procedure page.