Frequently Asked Questions
A clinical trial is a research study using human volunteers to improve, or add to medical knowledge. Clinical trials frequently use new drugs, devices and dosages to develop new and improved ways to treat patients.
Your participation in a clinical trial can help other patients by contributing to medical knowledge and improving care. By participating in a clinical trial, you may also receive the newest treatments before they become widely available.
Before you can make an informed decision whether to participate, you should understand the possible risks and benefits associated with the study. This process is known as informed consent and is done with the informed consent form. The purpose of this form is to provide information about the research study and, if signed, will give your permission to take part in the study. The form describes the purpose, procedures, benefits, risks, discomforts and precautions of the research study.
During a research study, patients will work closely with the research team (physician, coordinator and technician). These study professionals guide the patient through the clinical trial by conducting exams, scheduling, data collection, treatment and other study tasks. The visit schedule, duration and treatment will vary from study to study and the study team will explain the study details during the consenting process. Once treatment is received, the study team will carefully monitor the patient through follow-up visits and phone calls.
The duration of your visit will vary based on the study and the visit requirements. Some studies have a longer screening visit and shorter follow-up visits, while others have longer follow-up visits when compared to the screening. The study team will specify the amount of time each visit will take.
Your study participation will be outlined in the consent form and will vary from study to study. The study duration is publicly available on www.clinicaltrials.gov . You can access our list of studies on "Our Clinical Studies" page, select your trial of interest and be taken to the clinicaltrials.gov study page.
Research studies are often paid for by the study sponsor, while others will be the patients/ insurance companies responsibility. The cost will vary from study to study and will be outlined in the consent form.
Some studies will compensate study participants for their time and participation. Compensation will vary from study to study and details can be found in the compensation section of the informed consent form.
Unfortunately, we cannot disclose study results or progress unless it comes from the clinical trial sponsor. All summaries or updates will be released by the sponsor and can typically be found on their website or news media outlets.
Most of our studies do not have distance requirements that specify how close you have to live to our site. With this in mind, we suggest patients live or stay relatively close to the participating site. By living in close proximity, we can address any adverse events or reactions in an urgent matter.
You can access our list of studies on "Our Clinical Studies" page, select your trial of interest and be taken to the clinicaltrials.gov study page. In addition to clinicaltrials.gov, the study sponsors' website will have information on your trial of interest.
The continuation of treatment with study drug after your last visit will depend on the FDA approval status of the drug. If the study drug is a new drug that is not FDA approved, then treatment cannot continue after all study visits have been completed. In other cases, the study drug is FDA approved and can be prescribed off-label if your physician feels it is the best option.
All clinical trials we conduct have inclusion and exclusion criteria. One of the primary reasons for these criteria is patient safety. Sometimes a study protocol will be amended and the inclusion/exclusion criteria changes.