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Information for Study Participants

What is a Clinical Trial?

Clinical trials are research studies in which people help doctors find ways to improve healthcare. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat conditions or diseases.

Why are there clinical trials?

A clinical trial is one of the final stages of a long and careful research process. Studies are done with patients to find out whether promising approaches to prevent, diagnosis, and treat various diseases and conditions are safe and effective.

What are the different types of clinical trials?

There are several types of clinical trials.

  • Treatment trials test treatments like a new medicine (drug), new approaches to surgery or therapy, new combinations of treatments, or new methods.
  • Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of developing a certain condition or disease. These trials look for the best way to prevent diseases in people who have never had the disease being studied. These trials may also look to prevent the disease from re- occurring or prevent a related disease in patients who have already had the disease.
  • Screening trials test the best way to find a condition or disease, especially in its early stages.
  • Quality of Life trials (also called Supportive Care trials) explore ways to improve comfort and quality of life for patients.

What are the phases of clinical trials?

Most clinical research that involves the testing of a new drug follows in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the participants. Clinical trials are usually classified into one of three phases:

  • Phase I trials: These first studies evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A Phase I trial usually enrolls only a small number of participants, sometimes as few as a dozen.
  • Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works.
  • Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to routine medical care. A participant will usually be assigned to the routine care group or the group receiving the new drug or treatment at random (This is called randomization). Phase III trials often enroll large numbers of people and may be conducted at doctors' offices, clinics, and centers.

Should I participate in a clinical trial?

People who volunteer to take part in clinical trials play an important role. They help doctors and scientists find new therapies and medicines to treat, prevent or cure a disease. The most common reason people join a clinical trial is to have access to new treatment that is not available as part of routine medical care. Others feel their participation may help scientists learn more about a disease and improve treatment options.

What are the potential risks and benefits of participating in a clinical trial?

The risks and benefits of participating in a clinical trial vary from study to study. They depend on the study procedures and treatments or medicines involved. Before you decide to participate in a clinical trial, your doctor and research staff will explain the possible risks and benefits.

How is the safety of participants protected in a clinical trial?

Keeping research participants safe is a top priority. An Institutional Review Board (IRB) must approve all studies. An IRB is an independent committee made up of doctors, lay people, and scientists. The IRB reviews the studies to help protect participant's rights. An IRB also works to protect participants from exposure to unnecessary risks. The U.S. Food and Drug Administration (FDA) also approves all clinical trials that involve experimental medicines.

What is informed consent?

Informed Consent means that you understand the risks and benefits of joining a clinical study and give your written consent to participating in the study. A participant's signature indicates that an individual understands all aspects of the study and that all questions have been answered. Each participant will receive a copy of their signed Informed Consent document.

Could I receive a placebo?

A placebo looks like the test drug, but it not active. In some clinical trials, one group of participants receives a placebo, and another group receives the test drug. This helps evaluate the effects of the drug. You may be assigned to the group receiving a placebo. If the study you are considering is using a placebo, that information and your chances of receiving the placebo vs. the study drug will be discussed with you. It will also be fully explained in the Informed Consent document.

What happens during a clinical trial?

The doctor will usually perform a physical exam and review your medical history. Participants are randomly assigned to a study group. Information about your study visits, schedule, medications and testing procedures are reviewed. Participants are given instructions on how to contact members of the research team. You should feel free to discuss any questions or concerns with a member of the research team at anytime during the clinical trial.

How do I take part in a clinical trial?

Many research volunteers hear about a study from their doctor. Others learn of a study from advertisements such as mailings, bulletin board notices, radio and television ads and the Internet. To learn more about a clinical trial, contact the clinical center for study information.

Who is eligible to participate in a clinical trial?

Each study has specific requirements that you must meet in order to participate. The clinical center can give you more information about a specific clinical trial.

Where are clinical trials conducted?

Clinical trials are usually performed at a medical center, university, hospital or a doctor's office. The study location depends on the study protocol, tests and procedures. Some sites are Clinical Research Centers that specialize in performing tests and procedures for research studies.

Who pays for the patient care costs on a clinical trial?

The study sponsor usually pays for patient costs for tests and procedures that are related to the research. Before enrolling in a clinical trial, you should ask the research doctor about what patient care costs are provided.

Participating in a Trial: Questions to Ask Your Doctor

Participants should ask the following questions during the informed consent process:

  • What is the purpose of the clinical trial?
  • Who can participate?
  • What are the risks and benefits?
  • How long will the study last?
  • How often are the study visits?
  • What study procedures are involved?
  • Will I be taking a study medication? If so, what are the possible side effects?
  • Who will pay for the study procedures, tests and medication?
  • What costs, if any, will I have to pay?

Where do the ideas for clinical trials come from?

Ideas for trials usually come from scientists and doctors with knowledge of the most recent research developments in their field who are dedicated to improving the care of patients with a specific illness.

What is a protocol?

A protocol includes all the procedures for carrying out the research study or clinical trial.

Who sponsors clinical trials?

Clinical trials may be funded by a federal agency, such the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services. Drug companies and manufacturers of medical devices as well as patient advocacy organizations, such as the Juvenile Diabetes Research Foundation International (JDRF) and the American Diabetes Association, also fund clinical studies. The type 1 Diabetes TrialNet studies are funded by the NIH, JDRF, and ADA.

What happens when a clinical trial is over?

After a study is completed, all of the information is collected and analyzed. The results are reported in the medical literature so they can be widely shared with other doctors and scientists. When the study is over, study participants return to the care of their usual providers.

Can a participant leave a clinical trial after it has begun?

Yes, a participant may withdraw from a study at anytime for any reason.

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