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What is Clinical Research?

Clinical research is the process by which new medicines are vetted for safety and efficacy. The data from the research studies are used to help improve the knowledge and science of medicine.

Who can Participate?

Clinical research trials are open to anybody. Studies have specific criteria for who can join, but generally, do not require insurance and include exams and lab work at no cost.

Why Participate?

Volunteers have a variety of reasons for joining a clinical research study. Including, early access to new treatments, financial benefits, and helping contribute to the science of disease prevention and treatment.

Why join a clinical research trial?

Our patients have a variety of reasons for joining a clinical research study. Here are some of the reasons we hear most common.

Early Access

Clinical research may offer some patients access to additional treatment options, including some which may not be available through their doctor. This is especially true for rare diseases.

Financial Benefits

Most of our studies offer patients a payment for their time and travel expenses. Also, patients may have access to medications on a study which are too expensive.

Advancing Science

All patients can feel good about the fact that the data obtained from our Clinical Research studies help scientists learn more about human physiology and how they can improve treatment options for patients with these diseases.

Genetics

Many diseases and conditions are genetic. By volunteering in a clinical research trial you're helping to stop, prevent, or treat diseases which may affect your loved ones.

The Clinical Research Process

1. Raising Your Hand

The first step in the process is to let us know that you're interested or may be interested in, volunteering for a clinical research study. You can call us or complete our online interest form. Let us know what conditions you're interested in and we'll let you know when a study becomes available.

2. Pre-Screening Consultation

Once we speak with you about your interests in studies, we will plan for a 15-30 minute consultation at our office. One of our team members will review the research process, explain some of the current studies we have and provide you with information to take home and review.

3. Informed Consent

Once we find a study your interested in, our team will call to schedule a screening visit. The first step of this visit is to provide you a detailed review of the study design, the medications or devices being used on the study, their side-effects, and other aspects of the trial. If you wish to continue, you'll sign the informed consent form, be given a copy for your records, and the screening will commence. As a reminder, you may withdraw consent to being on the study at any time.

4. Screening

After the informed consent has been signed the study team and investigator will collect information about your medical history, current and prior medications, and typically do a panel of lab work to ensure you're healthy enough to enter the study and meet the eligibility criteria. For studies with a payment, you will receive payment for completing this visit.

5. Enrollment

Usually, within a few weeks of your screening visit the study team will contact you regarding your eligibility for the study. If you did not qualify by meeting the study's eligibility criteria then the study process is over. If you did meet the requirements we will schedule the next appointment where you'll begin the study.

6. Medication Administered

Once on the study patients will be assigned to a treatment group. Often the treatment you receive is not known by the study team (called double-blinded or triple-blinded) so that the different doses or medications can be tested without bias. There may also be a placebo treatment group, meaning you may not receive a study drug at all and this serves as a control group in the study. Learn more about placebo-controlled studies below.

7. Payments

Most studies offer a payment to patients who participate in the study. This is called a stipend or travel reimbursement and is typically provided for each on-site completed visit including screening visits. Our site offers a few payment options and this is disclosed during your pre-screening and screening visits.

8. Follow-Up

Once the medication phase of the study is completed there is often a follow-up period where we continue to record changes in your health. Some studies offer an extension period where patients may stay on active treatment and be monitored for long-term safety and efficacy of the study medication. Our study team will disclose this option (if available) during the informed consent process.

What is a Placebo-Controlled Study?

Some studies have a placebo treatment regiment, which means the patient will not receive an active medication. Most studies with this control, offer a rescue treatment option for those who experience worsening conditions. This allows patients to be moved onto active treatment before the end of the placebo-controlled study period. Additionally, most studies with this treatment group will move patients onto active treatment after a set number of weeks. This ensures no patients are left without treatment for an extended period of time. Ask us about the possibility of being on a placebo-controlled treatment and if there's an available rescue therapy.

Frequently Asked Questions

Have more Questions?

Do you or someone you know have a rare disease?

Unfortunately, many rare diseases often lack sufficient treatment options. The FDA and NIH (National Institute of Health) has programs to assist pharmaceutical companies in researching new treatment options both financially and with fast-track programs. At STAT Research our mission is to help improve the lives and standard of living for our communities. If you have a rare disease and have few or insufficient options to treatment please let us know. We will work to help find research studies that may give you additional treatment options, and can notify you when new studies become available.

How to let us know...

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