Clinical Trials

Participating in Clinical Trials

Every day, research uncovers new information about epilepsy and seizures. Your involvement in clinical trials could help in the development of new medications or medical devices. You and many others may benefit from your willingness to become involved.

Volunteering to participate in a clinical trial is one of the best ways you can contribute to the understanding of epilepsy. Volunteers are vital to the clinical trial phase of the drug approval process. As a volunteer, you are the most critical link in a long chain of research and testing in the development of new medications.

The benefits of volunteering to participate in a clinic trial include:

  • Participating in a research process that may lead to new therapies.
  • Obtaining expert medical care with physicians that specialize in epilepsy and seizures during the trial.
  • Learning new information about your condition.
  • Gaining access to new research treatments before they become available to the public.

How Does Minnesota Epilepsy Group Protect Patients?

When conducting clinical trials, Minnesota Epilepsy Group’s most important responsibility is to protect patients through well-designed protocols, oversight and approval by a a dedicated Institutional Review Board (IRB) and a thorough informed consent process.

Clinical Trial Protocol

A protocol is a detailed plan that explains what will be done in a clinical trial and why. The plan is carefully designed to protect your health and welfare while addressing specific research questions. It outlines how many patients will participate, what medical tests they will receive and how often, and the treatment and monitoring plan. Research staff follows the protocol approved by the Institutional Review Board (IRB).

Who Is the Institutional Review Board?

An Institutional Review Board (IRB) is a group of healthcare professionals and members of the local community that review and approve a clinical trial before it begins. The IRB carefully reviews clinical trial activity. The primary responsibility of the IRB is to protect the safety and rights of clinical trial participants.

What Is Informed Consent?

Informed consent is the process designed to give volunteers the information they need to decide about participating in a clinical trial. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring the informed consent is obtained from each research volunteer before that person participates in the clinical trial. The consent is not a contract. You may decide not to participate at any time during the trial.

If you agree to participate in a clinical trial after learning all that is involved, then you, the trial’s principal investigator (or nurse, if called for in the protocol) and a witness will sign and date the informed consent form. A copy of the form will be given to you.

To learn more about Minnesota Epilepsy Group’s clinical trials currently underway, please call our office at (651) 241-5290 or e-mail us at clinicaltrials@mnepilepsy.net.