About Clinical Research

Clinical research is performed to study investigational drugs for diseases and conditions. Clinical research studies help determine if investigational drugs are safe to use and work to improve the health of people. 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.

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.

Participating in clinical research can be challenging. Speak with the study doctor about any questions you may have and let the study doctor know if you expect any challenges to participating in the study.

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

Regulations and policies have been developed to help protect the rights, safety, and well-being of people who take part in clinical research studies and to help ensure that these studies are conducted according to strict scientific and ethical principles.

Before a clinical research study can begin, an independent review board must review and approve the study. This group is called an IRB or institutional review board, and is comprised of doctors, scientists, and members of the community.

What is the informed consent process?

Because many clinical studies involve new investigational drugs or test medications in new ways, there are risks associated with study participation. It is important that you understand these risks before agreeing to participate in a study. The possible risks and benefits of study participation should be discussed with the study doctor. You are encouraged to ask questions and bring up any concerns you may have about study participation.

Once you have been fully informed about the study and have had an opportunity to ask questions, you must read and sign an informed consent document indicating you understand the possible risks and benefits of study participation, as well as your responsibilities as a study participant. You will receive a copy of the informed consent form to take with you.

What if I have questions during the study?

You can ask the study team questions before, during, and after the study. Before agreeing to participate, please make sure that you understand the possible risks and benefits of participating, as well as your responsibilities as a study participant. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.

Can I leave the study once it has started?

Study participation is completely voluntary. You can end your participation at any time, for any reason. If you would like to stop participating in the study, talk to the study doctor about how to leave the study safely. If you decide to leave the study early, the study doctor may ask that you return to the study site for a final visit.

Can I see other doctors during the study?

During the study, you should still see your regular doctor for all non-study-related care. You should tell the study doctor if you start taking any new medications, as they may have negative effects when taken with the study investigational medication.

Why would I participate in a clinical research study?

Clinical research studies (also called clinical trials) test the safety and efficacy of investigational medications for diseases and conditions. Many treatments used today are the result of past clinical research studies.

Participating in a study is a way to potentially learn more about your disease and how to take care of your health. If you choose to participate in the BALANCE study, your hypoparathyroidism will be closely monitored under the guidance of the study doctor. You will receive all investigational study medication and study-related tests and procedures at no cost.

Study participation is voluntary, and you can leave the study at any time. Although you may not benefit directly from being in the study, the information gathered in the study may help you as well as others with hypoparathyroidism in the future. Talk with the study staff for more information about BALANCE study participation requirements and potential risks and benefits before you decide to participate.

The study doctor and staff respect your privacy. Details about your health will not be shared with anyone who is not associated with this clinical research study unless you have given your permission (or if required by law).