Clinical Trial FAQ

WHAT IS CLINICAL RESEARCH?

Clinical research is the way doctors and scientists learn about new ways to prevent and treat illness in people. Clinical research is the fastest way to find answers to the many questions about health and disease. It is sometimes called “human research” or a “clinical trial.”

With WMRAD, most research that needs human volunteers happens in the hospital and clinics. Other types of research studies take place in a doctor´s office, a treatment center, a nursing home, or a community clinic. Some studies involve asking questions in an office, by telephone, or even on the street or in a home.

WHAT IS A CLINICAL TRIAL?

A clinical trial is a strictly controlled research study conducted in people. Each study is carefully designed to answer specific questions about a new treatment like a drug or a medical device to make sure it is safe and effective to use in people.

The details of the clinical trial, including all the tests and procedures used in the study, are outlined in a research plan, also called a protocol. The doctors, nurses, and scientists who run the clinical trial must follow the protocol and run the tests according to the strict rules set by the Food and Drug Administration (FDA) and other government agencies. The rules ensure that people who participate in the clinical trial are treated as safely as possible.

WHY ARE CLINICAL TRIALS IMPORTANT?

Clinical Trials are important to develop new therapies and treatments. Many of the standard treatments accepted and used by doctors today are based on the results of previous clinical trials.

WHO SPONSORS CLINICAL TRIALS?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as medical institutions, foundations, voluntary groups, pharmaceutical companies and federal agencies such as the National Institutes of Health (NIH). Trials can take place in a variety of locations, such as hospitals, doctors´ offices, or community clinics.

WHAT IS A PROTOCOL?

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. 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 following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their tr eatment.

WHAT ARE THE DIFFERENT TYPES OF CLINICAL TRIALS?

Treatment trials test experimental treatments, new combinations of drugs, or test new approaches.

Prevention trials test new approaches to prevent disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions earlier.

Quality of Life trials explore ways to improve comfort and the quality of life for individuals with a chronic illness.

WHAT ARE THE PHASES OF CLINICAL TRIALS?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

Phase I trials test experimental drugs or treatments in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. These studies typically offer little or no benefit to the volunteer participants.

Phase II trials test an experimental study drug or treatment in a larger group of people (100-300) to see if it is effective and to further evaluate safety and learn how it helps the condition under study.

Phase III trials test an experimental study drug or treatment in even large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV trials are post marketing studies that collect additional information including the drug´s risks, benefits, and optimal use.

WHAT IS AN INSTITUTIONAL REVIEW BOARD?

An Institutional Review Board, also called an IRB, is a committee of doctors, scientists, and people from the community where the clinical research is taking place. An IRB reviews the clinical research plan to make sure people in the research study will be treated fairly and that any risks will be explained to them.

WHO VOLUNTEERS FOR RESEARCH?

People who volunteer to participate in research come from all walks of life. Volunteers may be healthy and participate in clinical research, or they may be patients or other people with health problems.

People with a specific type of medical condition or disease may be asked to volunteer for a research study because doctors want to learn more about their condition or there may be a promising new treatment being studied.

Because disease and life-threatening conditions affect everyone regardless of race, gender, age, and national origin, volunteers are needed for many types of research studies.

CAN CHILDREN PARTICIPATE IN CLINICAL RESEARCH?

Yes. Just like for studies with adults, there are guidelines explaining who can take part. The child´s parent or guardian needs to give permission for their child to participate. If the child is an adolescent or old enough to understand what the study is about, the child will also be asked to give their assent to take part in the study.

HOW LONG DOES A RESEARCH STUDY TAKE?

Each study is different. The amount of time a study takes depends on the research questions the study is designed to answer. A study may take a few hours, a few months, or even years to finish.

WHAT ARE THE POTENTIAL BENEFITS OF BEING IN A CLINICAL RESEARCH STUDY?

Participation in a clinical research study has several potential benefits:

* A chance to take part in clinical research that will help you and the researchers learn more about your condition or disease.

* he chance to receive a new and potentially promising treatment that is not available to the general public.

* The chance to receive care for your condition at one of the nation´s leading teaching hospitals.

* A chance to take part in clinical research that will hopefully find better ways to prevent and treat diseases in the future.

WHAT ARE THE POTENTIAL RISKS OF BEING IN A CLINICAL RESEARCH STUDY?

Along with benefits, there are potential risks and drawbacks of participating in a clinical research study:

* Your disease or condition may not get better with the experimental treatment.

* You may experience side effects or have a bad reaction to the study treatment you receive.

* You may be in the group that gets a placebo (a sham or inactive treatment). A placebo is like taking a sugar pill and will not cure a disease.

* You may be in the group that gets standard treatment instead of the experimental treatment being studied.

* You may have to visit the doctor more often than you would for regular, standard care. The visits might involve having lab tests and procedures done.

WHAT HAPPENS IF I THINK I WANT TO VOLUNTEER FOR CLINICAL RESEARCH?

If you think you might want to volunteer for a clinical research study, tell the researchers you are interested in learning more. Someone from the research team, usually the principal investigator (the physician in charge of the study) or a trained staff member will explain the details of the study to you. The information must include the following:

* The purpose or goals of the study

* A description of the study design, such as the use of placebos, controls, and whether the study is conducted in a blind or double-blind manner

* Why the study is being conducted

* Information about the treatment being studied and how the treatment will be administered

* Exactly what your participation involves- the exact tests and procedures you will be required to undergo and the amount of time the study will take

* The know risks and benefits of participation

* Alternative treatments that are currently available

* Contact information for the investigator

* Contact information for the Institutional Review Board

* A statement that your participation in voluntary and that you may stop or withdraw from the study without any penalty

During this discussion you should ask as many questions as you want in order to fully understand the details of the study. Take as much time as you need to make your decision. You may want to ask family members or friends to read the consent form.

If you decide to participate in the research study, you will be asked to sign the consent form.

If you agree to participate, and after you sign the consent form, you may be asked to take part in screening tests to make sure you qualify for the research study. Researchers use a set of guidelines to help them select volunteers for the clinical research study. They want to make sure it is okay for volunteers to participate.

WHAT IS INFORMED CONSENT?

Informed consent is a process of learning the important facts about the clinical trial to help people decide whether to participate. Informed consent is a process throughout the study to provide ongoing information for participants. After learning about the study, participants will be able to ask the researcher or his/her research staff questions. People should only agree to take part in a study if they clearly understand the study and feel comfortable. If they agree to take part in the study, they will be asked to read and sign an “informed consent form”. Signing the form does not require patients to stay in the study. Participants can leave the study at any time during the study or the follow-up period.

CAN I CHANGE MY MIND?

YES. If you decide to be in a study now and you change your mind later, that is okay. You just have to tell the study doctor or the study staff as soon as you change your mind. They may ask you to come back for a final visit to check your health.

DO I HAVE OTHER CHOICES BESIDES BEING IN A RESEARCH STUDY?

It is always your choice to participate, or not to participate in a research study. Whether you are a healthy volunteer or you have an illness, you will want to find out all the details of the study before deciding to participate or not.

DO I HAVE TO PAY TO BE IN A RESEARCH STUDY?

Financial arrangements are different for every research study. Research costs, such as the cost of hiring personnel and managing data, are covered by the organization paying for the clinical study. Some research studies will pay you for joining the trial, but many will not pay you for participating. Some studies will reimburse some of your expenses, such as transportation and parking fees.

Costs for some studies, like clinical trials for drugs and implantable medical devices, may be charged to you or your medical insurance. You should seek more information about the financial arrangements from the clinical research team and from your insurance provider.

WILL OTHER PEOPLE KNOW ABOUT MY PARTICIPATION IN A RESEARCH STUDY?

Information about you and your participation in a research study will be kept as confidential as possible. Information will be given only to those who have permission to see your records. This may include the group sponsoring the study and those who make sure the study is safe and carried out according to the research plan. Some studies are reviewed by the Food and Drug Administration (FDA).

WHAT HAPPENS TO THE CLINICAL RESEARCH DATA?

Researchers review and analyze data collected during the research study. Results of clinical studies are sometimes published in medical journals, but your identity will not be revealed.

A single research study may take place at many different medical centers at the same time. After the study has been completed, all the information is send to one central place to be analyzed. If the study was sponsored by a government agency, such as the National Institutes of Health, officials from the agency will review the study information.

If the clinical study was conducted to get FDA approval for a new drug or medical device, the completed data will be submitted to the FDA for review. If the FDA fids the treatment to be safe and effective, the agency may approve the treatment for use in the general public.