Frequently Asked Questions

What is a Clinical Trial?

A clinical trial is the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the drug or device is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the Food and Drug Administration (FDA). The FDA sets the rules to make sure that people who agree to be in the studies are treated as safely as possible.

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What is a Phase I Clinical Trial?

In a Phase I trial, researchers test an experimental drug or treatment in a small group of healthy people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Read More >>>>

 

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What is a Phase II Clinical Trial?

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300 volunteers) to see if it is effective and to further evaluate its safety and tolerance.  Read More >>>>  and also visit www.acrpnet.org.

 

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What is a Phase III Clinical Trial?

In Phase III trials, the experimental study drug or treatment is given to 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. Read More >>>>

 

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What is a Phase IV Clinical Trial?

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use. Read More >>>>

 

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Why volunteer?

By taking part in a clinical trial, you can try a new treatment that may or may not be better than those that already exist. You can also help others better understand how the treatment works in people of different races and genders.  Read More >>>>

 

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How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.  Read More >>>>

 

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

Benefits Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

•  Play an active role in their own health care.

•  Gain access to new research treatments before they are widely available.

•  Obtain expert medical care at leading health care facilities during the trial.

•  Help others by contributing to medical research.

 

Risks

•  There are risks to clinical trials.

•  There may be unpleasant, serious or even life-threatening side effects to experimental treatment.

•  The experimental treatment may not be effective for the participant.

•  The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

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What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

Plan ahead and write down possible questions to ask and bring a friend or relative to come along for support and to hear the responses

to the questions. Read More >>>>

 

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Does a participant continue to work with a primary heath care provider while in trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete

primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications

or treatments will not conflict with protocol.  Read More >>>>

 

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Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.  Read More >>>>

 

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What should I consider before I agree to participate in a study?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

•  What is the purpose of the study?

•  Who is going to be in the study?

•  Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?

•  What kinds of tests and experimental treatments are involved?

•  How do the possible risks, side effects, and benefits in the study compare with my current treatment?

•  How might this trial affect my daily life?

•  How long will the trial last?

•  Will hospitalization be required?

•  Who will pay for the experimental treatment?

•  Will I be reimbursed for other expenses?

•  What type of long-term follow up care is part of this study?

•  How will I know that the experimental treatment is working? Will results of the trials be provided to me?

•  Who will be in charge of my care?

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What happens if I do not want to take part in the study?

At any time before or during the study, you can decide not to participate. It will not affect the care you receive at Westfield Family Physicians. Please tell your doctor or nurse as soon as you decide. Read More >>>>

 

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What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. Read More >>>>

 

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What is the duration of a study?

Each study is different. Some studies may last a few hours, some a few months and others may last years. This information will be outlined in the consent before you agree to participate in the study.

 

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What is an Institutional Review Board (IRB)?

A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.  Glossary of Clinical Trials Terms

 

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Before you decide whether you want to participate in an investigational trial, you have the right to:

•  Be informed of the nature and purpose of the investigation.

•  Be given an explanation of the procedure to be followed in the medical investigation and any drug or device to be utilized.

•  Be given a description of any attendant discomfort and risks reasonably to be expected from your participation in the investigation.

•  Be given an explanation of any benefits reasonably to be expected from your participation in the investigation.

•  Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to you, and their relative risks and benefits.

•  Be informed of the avenues of medical treatment, if any, available to you after the investigational procedure if complications should arise.

•  Be given an opportunity to ask any questions concerning the medical investigation of the procedure involved.

•  Be instructed that consent to participate in the investigational procedure may be withdrawn at any time and that you may discontinue participation in the medical investigation without prejudice.

•  Be given a copy of this form and the signed and dated written consent form.

•  Be given the opportunity to decide to consent or not to consent to the medical investigation without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on your decision. www.fda.gov

 

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Am I committed to stay in the study until it is complete?

The study team would like you to complete the study; however, all research studies are voluntary. You have the option of leaving the study at any time. Also, the study team may remove you from the study if the physician feels that it is in your best interest.

 

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Who supervises the research and the study?

All research studies are closely monitored. Members of an ethics committee (IRB-Institutional Review Board) review the study. In addition, the sponsoring pharmaceutical companies review each study with the FDA (Food and Drug Administration) before the study begins. Local medical doctors from Westfield Family Physicians supervise the clinical trials. Great Lakes Medical Research coordinators will work with you.

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What happens to the information that is collected?

The information is confidentially collected without disclosing participants from the study and data is reviewed by the sponsor running the study. The information is then analyzed and results of the study are prepared. If the results of the study are positive, and the phase of the study permits, the drug may be submitted to the FDA for marketing approval.

 

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Will I know what treatment I was on during the study?

Some sponsors will inform participating sites what treatment their patient’s received while in the study; however, often this information may not be available for an extended period of time well after completion of the study.

 

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What are "blind" or "masked" studies?

A randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. Read More >>>>

 

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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 treatment.  Read More >>>>

 

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What is the purpose of a clinical trial?

The purpose of a clinical trial is to determine whether a new treatment option is safe, effective, and better than current standard care.

 

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How does a clinical trial differ from standard care?

A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. 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 in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. Standard care is the treatment regimen or medical management based on sate of the art participant care and has been proven effective and is currently being used.

 

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