Frequently Asked Questions

Below you’ll find brief answers to common questions to help you better understand the clinical trial process.

What is a clinical trial?

A clinical trial is a research study of medical treatment in volunteer patients, also referred to as participants. Clinical trials are used to learn if treatments are safe and effective to treat or prevent medical conditions and understand if new therapies can improve quality of life. The data from clinical trials is needed to support the approval of new treatments by the US Food and Drug Administration (FDA) and other similar agencies worldwide.

How are clinical trials run?

Clinical trials are led by a doctor, nurse, social worker or other medical professional trained to conduct clinical trials properly, safely and ethically. The healthcare professionals running clinical trials are called Principal Investigators.

Clinical trials run in a controlled manner and follow protocols with set guidelines for each trial. The protocol defines how the trial will run, including treatments used, trial duration, participant evaluations and diagnostic tests collected from the volunteers.

All Principal Investigators and patients participating in a clinical trial follow the same protocol, so that all patients are treated consistently and equally. This allows for even the smallest of differences between treatments to be seen.

How do I join a clinical trial?

Deciding to participate in a clinical trial is a significant and personal decision. Joining a clinical trial is your decision, and you may drop out of a trial at any time.

Before you join a trial, you’ll meet with the Principal Investigator to discuss known risks and benefits of the treatment, the schedule of visits and tests required by the protocol and treatment options available in the protocol. The Principal Investigator will explain the protocol procedures to you in detail so you understand the schedule and know when to meet with the Principal Investigator or staff to provide new evaluations.

If you decide to join the study and provide written informed consent to participate, you’ll have diagnostic tests performed to see if you meet the criteria to be enrolled. Not everyone will meet the entry criteria, so not everyone can be enrolled.

What happens in a clinical trial?

The clinical trial protocol defines clinical trial participation requirements, and every patient must meet the requirements before enrollment. After you provide your consent to join a trial, you’ll undergo a series of diagnostic tests to see if you qualify.

If you qualify, you may be given a treatment to use during the trial. The protocol may require the treatment to be masked or blinded to prevent the false perception that one treatment is better than the other. If treatment is blinded, you may not know what treatment you receive.

You’ll participate in a series of medical and physical examinations to measure the effects of the treatment over the trial duration. Trial duration, clinic visits and testing schedules vary from protocol to protocol. Some protocol procedures may be done at the Principal Investigator’s clinic, and some may be completed by you at home.

At the end of the trial, data from your visits and testing will be collected, pooled with patients from other sites and analyzed to see if the treatment has a real medical benefit. The data you contribute during participation is very important to understanding treatment effects, so you’re encouraged to complete the trial to the end. Your data will be used to advance science and improve medical care for patients like you.

Who can I talk to about joining a clinical trial?

Please feel free to call one of our experienced study professionals to find out more about clinical trials. We’ll gladly answer any questions or concerns you may have and discuss the clinical trials we’re currently running.

Any Questions?