FAQ

A clinical trial is a collaborative effort to further develop a medical intervention. These interventions can be medicines, devices, or other means to provide a treatment. Clinical trials take place all over the world and many types of people participate for different reasons. Study participants participate voluntarily and provide valuable information on the best use of new and old medicines. Very specific data is collected on treatment efficacy and tolerability. Our participants are medical heroes and serve as a crucial part of everyday treatment options for many illnesses.

Prior to any clinical trial assessments, each patient will be given an informed consent document. This document must be signed prior to any study-related procedures. As part of the consent process, you will have time to review the document in its entirety. The consent lays out the purpose of the study, the patient benefits, the possible medication side effects, and all other study-related details, including patient compensation. You will review and sign your consent with a research coordinator or physician. We encourage you to ask as many questions as you wish and take as much time as you need. You will be given a copy of your informed consent document for your records.

The typical parts of a clinical trial are Prescreening, Screening, Treatment, and Follow-up Care. Some of the study visits are required to be done at the clinic, and others are permitted to be done remotely, over the phone.

If you are considering participation in a clinical trial, we welcome and encourage you to consider a Screening appointment. The Screening appointment is where you are informed of all study details, including the rationale for the study treatment and design. You are informed of all study objectives, possible risks, and possible benefits. If you choose to participate and are a good candidate for the trial, you will then proceed to the treatment period of the study. This is where you will receive the investigational medication and have regular clinic visits with our doctors and coordinators. During the treatment period, you are frequently interviewed, and data is collected on your experience. After the completion of the trial, you will be followed by our Aftercare Team as you transition back to your regular care provider.

No. No insurance or payment information is ever collected for your study participation. In most cases, clinical trial participants receive a study participation stipend. This is not a payment to participate, but rather a stipend provided to study participants to offset their study visit day-related expenses, such as gas, parking, or meals. The amount of the participant stipends vary from study to study and is approved by an Institutional review board (IRB). They are the same for every participant in a particular clinical trial and they are not negotiated or changed without further IRB approvals. Study participants receive their stipend at the end of every study-related visit, usually in the form of a check.

Our clinical trials have very specific requirements for who can or cannot participate. These requirements are often called “inclusion criteria” and “exclusion criteria”. A person who qualifies for participation will have met all of the required terms for a particular trial. Patients are only enrolled in a study if they are appropriate.

Some clinical trials require a previous diagnosis of the research indication, while others allow a diagnosis to be made as part of the research study screening process. No individual can participate in a clinical trial without meeting the criteria for a clinical diagnosis. A full medical and psychiatric evaluation, with our physicians, is required for each patient wishing to participate in a study. Not all patients will meet the entry criteria for a study.

Clinicians and study coordinators will frequently ask you questions that help to determine if you are a good candidate for a particular trial, before and during the trial. It is important that you are open and candid about your medical and psychiatric history and that you are willing and able to have these conversations. Our clinical trial raters will assess and quantify your symptoms and responses throughout the study. That information is what we call clinical trial data. We cannot do this without you and your input.

If you are enrolled in the treatment portion of a clinical trial, and even before that, your participation is 100% voluntary. You may withdraw from the study at any time and for any reason. Our study coordinators will do whatever they can to help you to finish a clinical trial, but only if you chose to. While study completion provides essential information for the success or failure of a clinical trial, the needs and choices of the study participant are held in the highest regard.

The clinical trial, or clinical research, industry robust and in need of medical heroes to make a difference through their study participation. While Core Clinical Research is dedicated to Central Nervous System (CNS) studies, many other types exist. Here are some great resources for you to consider as you prepare for your participation:

The Center for Information and Study on Clinical Research Participation (CISCRP):

https://www.ciscrp.org/

United States government registry of clinical trials:

https://clinicaltrials.gov/

National Institutes of Health:

https://www.nih.gov/health-information/nih-clinical-research-trials-you/what-is-clinical-research

We will ask about your age, gender, previous or current medications, type and stage of a condition or diagnosis, current and past symptoms and level of impairment, previous and existing medical conditions, and prior participation in a clinical trial.

A more detailed history and presentation is collected from study participants as they make progress into the clinical trial.

If you are eligible and interested after a prescreen call, you will be able to make an appointment for a Study Screening Visit and you will receive a very thorough medical and psychiatric evaluation. All study related examinations and care are at no cost to you. When you schedule your first appointment with us to determine eligibly for a clinical trial there will be some required assessments. The assessments that are required are determined by the research protocol for the specific clinical trial that you are interested in participating in. All assessments are at no cost to you. Some common tools used to determine study eligibility may include:

• Blood/urine samples (sometimes fasting)

• A test that records the electrical activity of your heart, known as an electrocardiogram (ECG)

• Vital signs (height, weight, blood pressure, heart rate & temperature)

• Medical History Interview

• Physical Examination

• Psychiatric Evaluation

• Other diagnostic tests and assessments, such as imaging

All of the study related information is private and not shared with anyone unless you sign a Release of Information Form with our clinic. All study records including lab results, medical findings and ECG results are available to you at your request upon completion of the study.