FAQ What is a clinical trialWhat is a clinical trial?

A clinical trial is a research study in which participants receive investigational treatment from a qualified physician and other research professionals to determine the benefits of certain pharmaceuticals.

ClinicalTrials.gov describes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, of which the outcomes are measured. Observational studies are those in which individuals are simply observed and their outcomes are measured by the investigators.

Why participate in a clinical trial?

There are many benefits to participating in a clinical research trial. Effectively designed and executed clinical trials are the best approach for participants to:

• Play an active role in their own healthcare.
• 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.

Who can participate in a clinical trial?

All clinical trials have guidelines that determine who qualifies. This is done through inclusion/exclusion criteria, which helps medical researchers produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria," and those that disallow someone from participating are called "exclusion criteria." Criteria for participation is based on such factors as

• Age
• Gender
• Type and stage of a disease
• Previous treatment history
• Other medical conditions.

Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. Inclusion and exclusion criteria are used to identify appropriate participants and keep them safe. The criteria also help ensure that researchers will be able to accurately answer the questions they plan to study.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. For all types of trials, the participant works with a research team. The team consists of qualified doctors and nurses as well as social workers and other healthcare professionals. They work together to:

• Check the health of the participant at the beginning of the trial
• Give detailed instructions for participating in the trial
• Monitor the participant carefully during the trial
• Stay in contact with the participant after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent communication with the research staff.

What are the risks of a clinical trial?

• The experimental treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a nonprotocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.

What are the different types of clinical trials?

• Treatment trials test experimental treatments or new combinations of drugs. They also assess new approaches to surgery or radiation therapy.
• Prevention trials seek better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
• Diagnostic trials are held to determine better tests or procedures for diagnosing a particular disease or condition.
• Screening trials test the best way to detect certain diseases or health conditions.
• Quality of Life trials (or Supportive Care trials) study ways to improve the comfort and quality of life of individuals with 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.

In Phase I trials, researchers test an experimental drug or treatment in a small group of 20 to 80 people for the first time to assess its safety, determine a safe dosage range and pinpoint side effects.

In Phase II trials, researchers give the experimental study drug or treatment to a larger group of people (100-300) to determine its effectiveness and further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to a large group between one and three thousand participants to confirm its effectiveness, track side effects, compare it to commonly used treatments, and collect information that will allow the treatment to be used safely.

In Phase IV trials, post-marketing studies outline additional information, including the drug's risks, benefits, and optimal use.

What is informed consent?

An essential part of the clinical trial procedure is to tell participants key facts of the clinical trial using procedures under a sign document called “informed consent.” Informed consent 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. If the participant's native language is not English, translation assistance can be provided. 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.

How is the safety of the participant protected?

Brownstone Clinical Trials follows the legal and ethical codes that govern medical practice, as well as clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants.

Our trials follow a carefully controlled protocol, which is a study plan which details what researchers will do in the study. As a clinical trial progresses, our researchers report only 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, as patient confidentiality is paramount at BCT.

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

Our patients’ comfort and clear understanding is a top priority at Brownstone Clinical Trials. Here are a few suggestions to increase your comfort:

• Plan ahead and write down possible questions to ask. Some potential questions
are listed under the next FAQ.
• Ask a friend or relative to come along for support and to hear the responses to the questions.
• Bring a tape recorder to record the discussion to replay later.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board to make sure the risks are as low as possible and are worth any potential benefits. The Board is an independent committee of physicians, statisticians, community advocates, and others who ensure a clinical trial meets ethical standards and who protect the rights of study participants. Federal regulation mandates all institutions that conduct or support biomedical research involving people must have an IRB that initially approves and periodically reviews the research.

What should people consider before participating in a trial?

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 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?
• Who will be in charge of my care?
• 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?
• 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?
• 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?

Does a participant continue to work with a primary healthcare provider while in a 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 healthcare provider work with the research team, the participant is assured that other medications or treatments will not conflict with the protocol.

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

Yes. Participants may leave the clinical trial at any time. When withdrawing from the trial, the participant should let the research team know and communicate the reasons for leaving the study.

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
• Pharmaceutical companies
• 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.

Clinical Trial Glossary

Control or control group: A control is the standard of comparison for checking the
results of a drug or experimental treatment. In many clinical trials, one group of patients
will be given an experimental drug or treatment, while the control group is given either a
standard treatment for the illness or a placebo. Then results are measured against one
another.

Placebo: A placebo is a harmless or inactive pill, liquid or powder that has no treatment
value. It is used as a control in a study. In clinical trials, experimental treatments are
often compared with placebos to assess the experimental treatment's effectiveness. In
some studies, participants in the control group will receive a placebo instead of an active
drug or experimental treatment.

Protocol: A protocol is a study plan on which a clinical trial is based. The plan is carefully
designed to ensure the health and safety 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, type of procedures or medications, medication dosages, and
the length of the study.