The ADHD Clinical Research Studies

About Clinical Research

Clinical research studies (also called clinical trials) test the safety and effectiveness of investigational drugs for diseases and conditions. Before any medication, therapy, or medical device can be approved and made available to the general public, it has to go through several phases of clinical research.

Conducting research in children is important, as children are different from adults. It is important to assess the safety and effectiveness of all new investigational drugs in children.

Frequently Asked Questions

Why do people participate in studies?

Clinical study participation is completely voluntary. People participate in clinical research studies for a variety of reasons. Some volunteers may participate in studies because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease so that it may help others in the future.

What requirements are in place to help protect clinical study participants?

Each clinical research study follows a carefully controlled written research plan called a protocol, which describes what the researchers will do in the study. The protocol includes safeguards like criteria for study participation and instructions on how study staff are to conduct the study.

Clinical research studies in the United States are also monitored by ethics committees called Institutional Review Boards or IRBs. An IRB is a committee of independent doctors, nurses, and members of the community who help review clinical research to ensure that the rights of study participants are protected.

What is the informed consent process?

The informed consent process and informed consent form help patients decide whether or not to participate in a clinical research study. The informed consent form provides key information about a study, such as the purpose of the research, its potential risks and benefits, what is required of study participants, and the rights of study participants.

Before joining any clinical research study, potential participants who are age 18 or older and of sound body and mind are required to sign an informed consent form to acknowledge that they were provided information about the study and possible risks of participation and that they agreed to participate in the research. For children who are younger than 18 years old and adults who are unable to provide written consent for themselves, a parent or guardian will be required to sign the informed consent form for their child. Children may also be asked to sign a simplified version called an informed assent form.

Participants can choose to leave the study at any time and for any reason, even after signing the informed consent form.

What if I have questions during the study?

You and your child can ask the study team questions before, during, and after the study. If you have any concerns about your child participating in the study, you should feel comfortable discussing them with a member of the study team at any time.

Can my child leave the study once it has started?

You have the right to withdraw your child from the study at any time and for any reason. Your child’s regular, routine medical care would not be affected by a decision to leave the study.

Can my child see other doctors during the study?

Your child should continue to see their regular healthcare providers or specialists for any non-study-related care. You should tell the study doctor if your child starts taking any other medications, as they may have an interaction with the investigational drug.

Who pays for the study drug and tests?

The study sponsor, which is Shire Pharmaceuticals, provides the study drug and study-related tests and procedures at no cost. You will not pay for your child to participate in the study.

Will participants get paid to participate?

Study participants will not be paid to participate. However, all participants will be reimbursed for travel expenses.

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