Frequent Asked Questions

What is a clinical trial_

A clinical trial is a research study that evaluates new treatment options.  Such research relies on patients who volunteer to try the new or changed treatment.  Clinical trials are conducted in a health care setting (hospital or clinic), thus the name—clinical trial.  Sometimes they are called clinical studies, research protocols, or medical research.

What are the purposes 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.

How does a clinical trial differ from standard care_

Clinical trials test the safety and effectiveness of new treatment options.  Standard care is a treatment option that has been proven effective and is currently being used.  Likely, the standard care was proven effective based on past clinical trials.

Why are clinical trials important_

Today’s clinical trials lead to tomorrow’s standard care.  Advances in medicine and science result from new ideas developed through research.  Clinical trials help scientists develop improved treatments and sometimes lead to cures.

What types of cancer treatments are studied in clinical trials_

Scientists may study ways to prevent, detect, diagnose, control, and treat cancer.  They may also measure the psychological impact of the disease and determine ways to improve a patient’s comfort and quality of life.  Most clinical trials study new treatments; they are studied alone or along with surgery, radiation therapy, chemotherapy, gene therapy, immunotherapy, or newer types of therapies.

Are clinical trials safe_

Risks and side effects exist with almost any treatment whether it is standard care or a clinical trial.  However, many safeguards are in place to make clinical trials as safe as possible and protect patient rights.  Before a new treatment is tried with patients, it is carefully studied in the laboratory.  Laboratory research determines how best to use the new methods with people safely and effectively.

Any research involving people at NABTC institutions must be approved by each individual Institutional Review Board (IRB).  The IRB is made up of doctors from different specialties, ethicists (often a chaplain), administrators, and members of the public.  An IRB is required by the U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials.  Therefore, the IRB is authorized to review, require changes to, approve, or disapprove studies.

Clinical trial patients are carefully monitored.  Blood tests, x-rays, and other procedures are performed regularly to detect and record any changes, good or bad, in the patient’s condition.  The monitoring provides scientists with valuable data for making patient care decisions and for documenting research results.

How is a clinical trial designed_

Planning starts when a physician decides a new treatment may be beneficial and deserves evaluation.  The physician may work at a pharmaceutical company, a government agency, a health organization, a health care facility, or may be an independent physician.

The physician asks questions about the proposed new treatment.  For example, does the new therapy work as well as a current standard care but with less discomfort to patients_  Will the new treatment work better or faster than standard care_  Will the new treatment possibly be or lead to a cure_  Then the physician develops an action plan to try to answer the questions.

The action plan is called a protocol.  It details the objectives of the study, what will be done, and why.  For example, the protocol for a study that tests a new drug for brain tumor likely will include MRI or CT scans and regular blood tests to measure the drug’s effectiveness.

The protocol also details the conditions by which patients will be included or excluded from taking part in the study.  For example, patients with a certain type and stage of cancer will be included; patients with other types or stages will not be eligible.

A clinical trial often is the last method of testing new treatments.  clinical trials themselves usually go through three phases.

What are the three phases of a clinical trial_

Each phase of a clinical trial has a different objective.

• Phase I determines the best way to give a new treatment and in what doses.  It focuses on the relative safety of a treatment and involves a small number of patients.
• Phase II determines if the treatment actually works as expected.  It is performed with more patients than Phase I, typically with groups of 20 to 50 patients.
• Phase III compares standard care with the apparently good treatments from Phase II trials.  This phase relies on even more patients—often thousands of study participants.  Patients in Phase III must be randomized.

What is a randomized clinical trial_

A randomized clinical trial is a study in which patients with similar traits, such as extent of disease, are assigned by chance to one of two groups.  The treatment group receives the new treatment.  The control group receives the current standard care.  When no standard treatment exists, some studies compare a new treatment with a placebo.  Patients are told if this is a possibility before deciding whether to take part in a study.  However, most cancer treatment clinical trials do not use placebos because standard care is available to use as a control.

Why is randomization important_

Randomization is important to compare different treatments and assure a fair and impartial test of the treatment being studied.  The most effective way to avoid influencing the results of the study is by random assignment of study patients to a treatment group.  Randomized studies often are blinded studies.

What are blinded studies_

In blinded studies, the patient and/or the physicians do not know the study group to which a patient is assigned.  In a single-blind study, the patient doesn’t know which treatment she or he is taking.  In a double-blind study, the patient and the physician don’t know which treatment is assigned.  Blinding a study prevents individual biases of either the patient or the physician from affecting the study results.  If necessary, the treatment a patient is receiving in a blinded study can be quickly identified by a special code.

How do I know if a clinical trial is right for me_

You should talk with your doctor about all your treatment options, including clinical trials.  Ask if you might benefit from participating in a trial.  The physicians at NABTC institutions welcome opportunities to work in partnership with each other to provide the best and greatest number of treatment options for each patient.

Your decision should be made after careful consideration and understanding of all available treatment options and their potential benefits, risks and side effects, and the trial's costs, location, and duration.

Is a clinical trial the only option_

Often, a clinical trial is not the only option; it may be one of several treatments to consider. For some patients, though, all other treatments may have been tried, leaving a clinical trial as the only remaining alternative.

How do I know if I am eligible for a clinical trial_

The research typically is designed to test treatments under specific conditions, for example a certain type or stage of cancer or a physical condition.  Before you may participate in a clinical trial, the physician will ask you many questions to determine your eligibility.

What are the benefits of participation_

Patients participate in clinical trials for many reasons - usually hoping for a better treatment or a cure.  There are no guarantees, but physicians who conduct clinical studies believe the new treatment will be as good as or better than current standard care.  If so, study patients are among the first to receive the new treatment and the first to benefit if the treatment is successful.  Study patients receive close medical follow-up and testing to mon for various reasons, especially if the treatment is doing you no good or if it may be harmful.

Will I be penalized if I decide not to participate_

You will not be penalized if you decide not to participate in a clinical trial.  You still will receive the best standard care available.

Would I have to move or travel to participate_

In many cases, you would not need to travel to specialized hospitals to participate in clinical trials.  Studies are conducted at many different locations.  NABTC's clinical trials are multi-center studies; that is, they are conducted at many sites throughout the United States.  But, other studies are conducted at fewer sites and that may require you to travel or temporarily relocate.

How long does a clinical trial last_

The duration of a clinical trial can vary from a few months to several years.  For each trial, the duration is spelled out in the informed consent document and is explained to each study participant by the physician.

Who pays for clinical trials_

Cost is an important consideration for a patient thinking about entering a clinical trial.  Most clinical trials that test a treatment require clinic or hospital visits, x-rays, blood tests, or other medical procedures.  The patient may be responsible for some or all of those costs.  Some studies have a sponsor, often a pharmaceutical or biotechnology company, that pays some of the costs.  However, it is not often that all costs are paid by the sponsor.  Patients should always find out how much it will cost them to take part in a clinical trial.

Will my insurance company pay for any costs_

Health insurance and managed care providers do not always cover all patient care costs in a clinical trial.  Whether your insurance company pays any of those costs depends upon your insurance company, your insurance policy, and the study.  If the care and treatment of the trial is similar to that which the patient would receive if not a trial participant, an insurance company may pay.  In a more experimental trial, an insurance company may deny coverage.  Before making any decisions, you should call your insurance company to learn what its coverage would be for a specific clinical trial.

  [an error occurred while processing this directive]itor any change in their condition - whether it is study-related or not.

Clinical trials as well as standard care treatments have risks, side effects, and hoped-for benefits, all of which vary.  But since clinical trials are research into new treatments, not all risks are known ahead of time.  The scientist conducting the study explains any known or anticipated risks and benefits, which are also detailed in an informed consent document.

informed consent is a process by which a person learns about a clinical trial and agrees to participate.  The physician explains the purpose of the trial, expected benefits, known risks, and what is expected of the patient/participant. The physician also answers any questions the patient/participant may have.  If the patient agrees to participate in the trial, she or he signs an informed consent document acknowledging that the trial was explained and is understood.

You may decline to participate in a clinical trial at any point.  Even after you have signed the informed consent document, you may change your mind.  You may decline to take part in any htmlect of the study or you may leave the study.  Likewise, the physician may remove you from the study for various reasons, especially if the treatment is doing you no good or if it may be harmful.

You will not be penalized if you decide not to participate in a clinical trial.  You still will receive the best standard care available.

In many cases, you would not need to travel to specialized hospitals to participate in clinical trials.  Studies are conducted at many different locations.  NABTC's clinical trials are multi-center studies; that is, they are conducted at many sites throughout the United States.  But, other studies are conducted at fewer sites and that may require you to travel or temporarily relocate.

The duration of a clinical trial can vary from a few months to several years.  For each trial, the duration is spelled out in the informed consent document and is explained to each study participant by the physician.

Cost is an important consideration for a patient thinking about entering a clinical trial.  Most clinical trials that test a treatment require clinic or hospital visits, x-rays, blood tests, or other medical procedures.  The patient may be responsible for some or all of those costs.  Some studies have a sponsor, often a pharmaceutical or biotechnology company, that pays some of the costs.  However, it is not often that all costs are paid by the sponsor.  Patients should always find out how much it will cost them to take part in a clinical trial.

Health insurance and managed care providers do not always cover all patient care costs in a clinical trial.  Whether your insurance company pays any of those costs depends upon your insurance company, your insurance policy, and the study.  If the care and treatment of the trial is similar to that which the patient would receive if not a trial participant, an insurance company may pay.  In a more experimental trial, an insurance company may deny coverage.  Before making any decisions, you should call your insurance company to learn what its coverage would be for a specific clinical trial.