Clinical Trials & You

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What is a Clinical Trial?
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and new ways to improve health.

There are different kinds of clinical trials, including those to study:

·       prevention options

·       new treatments or new ways to use existing treatments

·       new screening and diagnostic techniques

·       options for improving the quality of life for people who have serious medical conditions

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study schedules of tests and procedures, drugs, dosages and length of study as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.

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Who Should Consider Clinical Trials?  
Some people participate in clinical trials because they have exhausted standard (approved) treatment options - which either did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.

Other people participate in trials because the want to contribute to the advancement of medical knowledge.

For each clinical trial, researchers develop eligibility criteria, such as the age, sex, type and stage of disease, previous treatment history, and other medical conditions. These criteria help to reduce the amount of variation in the study, without threatening the scientific integrity of the trial, by removing medical variations that might complicate analyzing the results.

Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a therapeutic agent.

How is a Clinical Trial Conducted?
An agreement form, which explains what is involved in the study is provided and reviewed with you by members of the research department. Being in a study is completely voluntary, and you can change your mind at any time even if you have signed the consent form.

All studies have guidelines about who can participate. They are not used to reject interested participants but rather to help produce reliable study results. 

You will be monitored carefully during the study and will likely be contacted by the research team after study procedures are completed. Some studies require more tests and doctor/clinic visits than you would normally have for an illness or condition.

Phases of clinical trials
Clinical trials are conducted in “phases.” Each phase has a different purpose and helps researchers answer different questions.

Phase I trials: Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.

Phase II trials: The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.

Phase III trials: The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety, seeking more information about a drug or treatment’s risks, benefits, and optimal use.

Where are Clinical Trials Conducted?
Clinical trials can be sponsored by an organization such as a pharmaceutical company and are conducted by a physician or health care provider. The sponsor determines the location(s) of the trials which are usually conducted at universities, medical centers, clinics, doctor's offices, and/or at hospitals.

What Should Patients Consider Before Joining a Clinical Trial?
People should learn as much as possible about the clinical trials that interest them. They should also feel comfortable discussing their questions and concerns with members of the research team. Prospective participants should understand what happens during the trial, the type of health care they will receive.

Anyone considering a clinical trial should also know that there are benefits and risks associated with participating.

Potential Benefits
Participating in well-designed and well-executed clinical trials is one approach for eligible patients/volunteers to:

·       get actively involved in their health care.

·       gain access to potentially new research treatments

·       have access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.

·       help others by contributing to medical research.

Possible Risks
There are generally known and unknown risks associated with clinical trials, such as:

·       there may be unpleasant side effects resulting from the treatment.

·       the treatment may not be effective for the participant.

·       the protocol may require more of the participant's time and attention than a standard treatment. (Participants may need to visit the study site on a regular basis, be subjected to additional tests, get more treatments than are normally necessary, stay in the hospital and/or follow complex dosage requirements.)

Payment/Compensation:
Subjects are sometimes paid for their participation in research, especially in the early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies is considered a a recruitment incentive. Financial incentives are most often used when health benefits to subjects are remote or nonexistent. Volunteers may be offered compensation in certain trials for their time, and for discomfort that may be experienced during the trial. The amount of compensation is determined by the amount of time you will be required to dedicate to the trial, and to the level of discomfort that might be associated with medical or surgical procedures related directly to the study. Payment information, including the amount and schedule of payment(s), as well as any possible costs to volunteers who participate in a study, are discussed with potential participants during the informed consent process, and documented in the informed consent form.

How are Clinical Trial Participants Protected?
US federal agencies including the Food and Drug Administration (FDA) and the National

Institutes of Health (NIH) oversee much of the clinical trials in the U.S. to protect the rights
and welfare of study participants. Institutional Review Boards (IRBs) oversee the centers where
clinical trials are conducted and ensure that a clinical trial is ethical and that study participants’
rights are protected. As a study participant, you have access to the IRB, a volunteer advocate, the
physician and the staff conducting the clinical trial.

 

For more information on participating in clinical trials, please visit:
www.fda.gov
www.nih.gov
www.clinicaltrials.gov