For Volunteers

Why are clinical research studies important?

Almost all medications we have today have gone clinical research study. We conduct clinic research studies to evaluate the safety and effectiveness of the medications before it become available to the public. It takes many years for a medication to be approved for use. Clinical research studies adhere to strict regulatory guidelines set by the Food and Drug Administration (FDA). Patient enrollment is completely voluntary and is free of charge to all research participants. Without volunteers, no new drugs would become available. We now have effective treatments for hundreds of diseases directly due to volunteers participating in clinical research studies.

What can I expect when enrolling in a Clinical Research Study?

Your participation begins after a review of your medical history by the coordinator and complete medical evaluation by a research physician. You will receive a comprehensive physical exam, close medical monitoring, laboratory and diagnostic evaluations, at NO cost to you. You will receive full disclosure of the risks and benefits involved. You will have the opportunity to review clinical drug study information and ask questions before you sign the consent form for the research study. During the study, you will be scheduled for regular clinic follow-up visits and meet with a research physician who will monitor and evaluate your progress. You will not be expected to continue in the study if you experience any adverse side effects. Remember, your participation in a clinical research study is completely voluntary. You will be paid at the end of your participation for your time and travel.

What are the phases of the Clinical Research Study?

Clinical Research Studies have four phases:

• Phase I – In phase I studies, a new drug is tested for safety, side effects and how the drug is administered. A small number of the patients are usually admitted to Phase I trials. If the Phase I study shows safety a Phase II study begins.
• Phase II - trials involve a larger number of patients and continue to evaluate the safety of the new drug and any less common side effects.
• Phase III - trials compare the new drug to the standard therapy. Phase III participants are randomly chosen to receive either the new drug or the standard treatment, or a combination of both.
• Phase IV - trials continue to evaluate the safety, benefits and optimal use of a therapy already approved and available to the public.

We are at Bearss Medical conduct Phase II, III, and IV only.

What are the potential risks and & benefits of the participating in a Clinical Trial?

Participating in a clinical trial has benefits but there also may be risks. Clinical trial participants may have side effects, which are sometimes serious, from study medication. Study treatment and evaluation may require more time than standard therapy.

Also, there is no guarantee the study medication will work.

However, the clinical trial participant may be able to gain access to a research treatment that is otherwise unavailable, and may help others by participating in medical research. Clinical trial participants may also have access to study medication, medical care, and laboratory services, all at no cost.

How are the Clinical Trial participants protected?

There are a number of groups and processes designed to regulate clinical trials and to help protect trial participants. Institutional Review Board, Peer reviews, and the Informed Consent process help protect the rights of the clinical trial patients.

An Institutional Review Board (IRB) monitors actions and documentation in the clinical trial process. Medical specialists, nurses, medical ethicists, patient advocates, social workers and clergy usually make up an IRB. The purpose of an IRB is to ensure that the trial patients are treated safely, ethically, fairly.

Peer Review is conducted by experts, chosen by a study sponsor, to gauge the merit, safety and ethical issues of a trial.

Informed Consent is the process of making sure the clinical trial participant has all the necessary information about the trial before deciding to participate or not. If you decide you are interested in the trial, you will first meet with a member of the research team. You will find out about the trial and receive the written information about the trial. This written information is called the Informed Consent document.

It’s important to understand the facts about the trial before making the decision. This is the time to ask your contact person any questions.

If you decided to join the trial, you will be asked to sign the document. Keep a copy for the reference. And remember that you are free to leave the trial anytime.

How do I know if participating in the Trial is right for me?

Choosing to participate in a clinical trial is an important personal decision. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

You need to talk with your doctor and your loved ones about any decisions concerning your participation in a trial. If you find a trial, take the time to ask questions and to understand if participating may be right for you.

Why do people enroll in a Clinical Research Study?

People volunteer to participate in research studies for a variety of reasons. Many people are interested in receiving the latest medications before they are available to the public. Others consider participation in a study a possible option to their current treatment, which may not be sufficiently effective. Finally, others volunteer to improve medications for future generations.

What about my regular doctor?

We encourage you to speak to your doctor about your interest in participating in a clinical research study. Our clinical research staff will be happy to consult with your doctor if you wish. It is NOT the intent of UCR to replace your doctors, but to work with them to enhance all your healthcare options. At your request, your records can either be shared with your doctor or remain confidential.