Patient Information

Clinical trials are scientific research studies designed to find better ways to treat or prevent diseases. The goal of these research studies is to learn whether a potential new medication, treatment or medical device is safe and effective in treating a particular disease or condition.

Unite Clinical Research Consortium could help your community make an educated decision about participating in a clinical trial and to help you understand the clinical trial process. Clinical research is impossible without the volunteer participation of patients. Unite Clinical Research Consortium is dedicated to safe, ethical and professional behavior when conducting a clinical trial. Therefore, it is very important that our patient community understand their rights and what to expect if they decide to participate in a clinical research study.

There are a few things to take into account before participating in a research study:

Check with your personal doctor. Your doctor can inform you about how to participate in clinical research and the risks and benefits of participating in a clinical trial.

Have a good understanding about your current state of health. You will be told about the known side effects and other health risks of the treatment(s), but not all of the risks can be known when you decide to participate in a trial as a volunteer. Also, be sure you report all the normal medications you are taking, including vitamins and herbals.

Ask lots of questions. Before you make a decision whether or not to participate in a clinical trial, ask lots of questions. If possible, read the information given to you about the study. Ask if you can take it home to read if you need more time. Sometimes it is helpful to make a list of questions in advance to ask the study coordinator or doctor.

Before you decide to participate in a clinical trial, a clinical research coordinator or physician will discuss the research study with you. This discussion will include a detailed explanation of the purpose of the trial and the type(s) of treatment to be studied, your chances of receiving a given treatment, the known risks and benefits of each treatment. You will always be given a chance to ask any questions you may have and enough time to make an informed decision. If you decide to participate in a clinical research study, you will be required to review and sign an Informed Consent document, which will also let you know whom to contact for more information and fully explains your rights during the trial. Regardless, you will always have the right to withdraw from the study at any time.

Frequently Asked Questions (FAQ)

We understand that many people consider participating in clinical research, for many different reasons. It may be that you are seeking the latest advances in medical research. It may be that you just want to be part of advancing medical science. In any case, we understand that it takes effort and commitment to be a study participant. We want to make the process as easy, interesting and pleasant as possible.

First and most important, we want to strengthen the partnership that you have formed with your doctor to protect and improve your health and quality of life. We believe that the better informed you are, the safer and healthier you are. It is in our interest as well as in your interest for us to do our utmost to protect your rights and safety.

What is a clinical trial?
A clinical trial is a research study to answer specific questions about vaccines, new therapies, new ways of using known treatments or diagnostic methods. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.

Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning Phase I Clinical Trials. New therapies are tested on people only after laboratory and animal studies show promising results.

What is a protocol?
All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial, the schedule of tests, procedures, medications, and dosages and the length of the study. While in a clinical trial, participants are seen regularly by the trial’s research staff to monitor their health and to determine the safety and effectiveness of the treatment.

What are clinical trial phases?
Clinical trials of experimental drugs proceed through four phases:

In Phase I Clinical Trials researchers test a study drug or treatment in a small group of healthy volunteers (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II Clinical Trials the study drug or treatment is given to a larger group of patients (40-100) to see if it is effective and to further evaluate its safety.
In Phase III Clinical Trials the study drug or treatment is given to large groups of patients (more than 200) to further determine its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV Clinical Trials studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.

What protections are there for people who participate in clinical trials?
Local government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. Every clinical trial must be approved and monitored by an Ethics Committee or Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. Unite Clinical Research Consortium studies are reviewed by an independent IRB group that ensures that a clinical trial is ethical, and the rights of study participants are protected. By federal regulation, all institutions that conduct or support biomedical research involving people must have an Ethics Committee that initially approves and periodically reviews the research.

What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before you decide whether to participate. These facts include:

Why the research is being done
What the researchers want to accomplish
What will be done during the trial and for how long
What risks are involved in the trial
What benefits can be expected from the trial
What other treatments are available to patients?
The fact that you have the right to leave the trial at any time

If you are considering joining a clinical trial, the research staff will give you informed consent documents that include the details about the study. Because joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and/or the informed consent form.

If you decide to join the clinical trial, you will receive a copy of the informed consent documents. It is also a good idea to discuss your decision (s) with your primary care physician, family, home care provider or friends.

Who can participate in a clinical trial?
All clinical trials have guidelines about who can get into the study. Guidelines are based on such factors as age, type of disease, medical history and current medical condition. Before you join a clinical trial, you must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Healthy volunteers participate in Phase I trials, some vaccine studies and trials on research on preventive care for children or adults.
The factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

Who sponsors clinical trials?
Clinical trials are sponsored by pharmaceutical, biopharmaceutical, biotechnology and medical device companies, individual physician-investigators, research institutions, universities, contract research organizations, and government research institutions. These clinical trials can take place in a variety of locations such as: hospitals, universities, doctor’s offices and community clinics.

What happens during a clinical trial?
The clinical trial process depends on the kind of trial in which you participate. The team will include doctors and nurses as well as social workers and other health care professionals. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study.
Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. For all types of trials, you will work with a research team. Your participation will be most successful if you follow the protocol carefully and stay in contact with the research staff.

What is a placebo?
A placebo is an inactive substance that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatments effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.

What is a control or control group?
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, and the control group is given either a standard treatment for the illness or a placebo.

What is a blinded or masked study?
A blinded or masked study is one in which participants do not know whether they are in the experimental or control group in a research study. Those in the experimental group get the medications or treatments being tested, and those in the control group get a standard treatment or no treatment.

What is a double-blind or double-masked study?
A double-blind or double-masked study is one in which neither the participants nor the study staff know which participants are receiving the experimental treatment and which ones are receiving either a standard treatment or a placebo. These studies are performed so that neither the patient’s nor the doctor’s expectations about the experimental drug can influence the outcome.

What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the drug or treatment. Experimental treatments must be evaluated for both immediate and long-term side effects.

What are the benefits and risks associated with clinical trials?
There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you can:
∙Take an active role in your own health care
∙Gain access to new treatments that are not available to the public
∙Obtain expert medical care at leading health care facilities during the trial
∙Help others by contributing to medical research

Clinical trials have risks:
∙There may be side effects or adverse reactions to medications or treatments
∙The treatment may not be effective for you
∙The protocol may require a lot of your time for trips to the study site, treatments, hospital stays or complex dosage requirements

Can I leave a clinical trial after it has begun?
Yes, you can leave a clinical trial at any time. If you plan to stop participating, let the research team know why you are leaving the study.

What Happens During a Typical Research Study?
Preliminary Screen
The study coordinator will ask you a series of questions over the telephone to make sure that you qualify for the study and if so, will schedule your first appointment.

First Visit
You will meet the study coordinator at the research site who will track your progress through the study.

Potential benefits of the medication being tested as well as any known risks of the medication and any alternative treatments for your condition will be explained to you. Any questions you may have regarding this information will be answered. A written version of this information, the informed consent form, is signed by the participant and witnesses prior to any study-related procedures being performed.
You will provide some background information regarding your medical history and current medications.
The physician will give you a physical examination and other specialized tests such as blood work, urinalysis, blood pressure, x-rays, electrocardiograms, etc. as may be required for the study. You will not be charged for medical care relating to your study participation.

Scheduled Visits (as per protocol or principal investigator)

During the study you will come in for scheduled appointments and will be asked questions as to how you are doing, if any changes in your condition have occurred, and about any medications you have taken since the last visit.
Depending on the study, a physical exam, additional blood work or specialized tests may be required at certain visits during the study.
Your unused medication and used packaging will be collected and you will be asked about your compliance in taking the study medication. Your next appointment will be scheduled.

Final Study Visit
This visit usually proceeds very much like the previous visits. If necessary, the physician may make recommendations for follow-up treatment for your condition. Also, if you are interested, the coordinator will discuss with you any other clinical trials for which you may be qualified if you are interested.

For more information on your participation on our future clinical trials please contact us at Unite Clinical Research Consortium at 1-866-434-0005 Ext. 220