About Clinical Trials, Clinical Trial Phases

What is a clinical trial?

A clinical trial is a research study that targets specific health issues in human volunteers. Performing clinical trials is one of the best methods in the clinical research field for finding new treatments and practices for combating illness. There are two types of clinical trial:

• Interventional clinical trials test the safety and efficacy of an experimental treatment in a controlled clinical research environment.
• Observational clinical trials study diseases or general health trends in populations where they naturally occur.

Why participate in a clinical trial?

Participating in clinical trials is a way of becoming actively involved in clinical research relating to one's own health issues and receiving treatments not otherwise available. Participating in clinical trials may benefit the individual as well as others by increasing understanding of diseases and their treatments.

Who is eligible to participate in a clinical trial?

Every clinical trial has specific criteria for participants in order to maximize the effectiveness of the study and obtain the most reliable results. There are "inclusion criteria" which allow someone to participate in a clinical trial and "exclusion criteria" which exclude someone from participating in a clinical trial. A study may require healthy participants or participants who are affected by the particular disease being targeted in the trial. The stage of illness, previous treatment history, gender, age and other factors can determine ones eligibility.

What happens during a clinical trial?

There are different kinds of clinical trials. The procedures used for a clinical trial are determined by what kind of trial it is. Doctors, nurses and other health care professionals make up the clinical research team that conducts the trial. They monitor the health of the patient through the entire process of the trial. The trial may or may not include additional doctors' visits to what one would normally have when treating the condition being studied in the trial.

The participant will be informed of the specific protocol to be followed in the clinical trial and there will usually be frequent contact between the participant and the clinical research staff.

Informed Consent

Before deciding to participate in a clinical trial, a prospective participant should understand the clinical trial process. The purpose of the trial, the duration of the trial, the relevant medical facts of the trial, and the potential risks and benefits involved in the trial will all be explained to the participant. Agreeing to participate in a clinical trial after coming to an understanding of these details is known as "informed consent". An informed consent document is provided to the participant detailing these factors and listing pertinent contact information for members of the clinical research team conducting the trial. The participant must sign the informed consent document in order to participate in the clinical trial. The process of informed consent continues throughout the clinical trial process as new developments take place. The participant always has the right to discontinue participation in the clinical trial.

Benefits and risks of participating in a clinical trial

Benefits

Properly conducted clinical trials provide participants an opportunity to:

• Become actively involved in clinical research pertaining to their own health issues.
• Receive cutting edge medical treatments that might not otherwise be available.
• Receive health care monitoring at top notch health care facilities for the duration of the clinical trial.
• Benefit others by making a contribution to increased medical understanding and the development of new treatments.

Risks

• The treatment may be ineffective for the participant.
• The treatment may have unpleasant or even dangerous side effects.
• The clinical trial process may require a substantial time and energy commitment for frequent treatments, tests, and check-ups.

How is the safety of the participant protected?

Clinical trials are federally regulated and include protocols designed to protect the safety of the participants. All legal and ethical standards of medical practice apply to clinical trials. The trial follows strict and detailed guidelines and periodic reports are made to medical journals, medical and scientific conferences and to government agencies. The anonymity of the participants is maintained in all reports.

What one should know before agreeing to participate in a Clinical Trial

Someone considering taking part in a clinical trial should try to learn as much as possible about the process of conducting the trial, the treatments involved, and the nature of the agreement between the participant and those conducting the trial. One should feel free to ask questions such as:

• What kinds of treatments will be administered?
• What kind of time commitment is involved?
• How will it affect my daily life?
• How does the treatment compare with treatments currently available?
• What are the risks and benefits of the treatment as compared to treatments currently available?
• Are there side effects associated with the treatment?
• Who will pay for the treatment?
• Will there be any expenses not covered by the study?

Every U.S. clinical trial must be approved by an IRB

An Institutional Review Board (IRB) is an independent committee of health care professionals, satiations, and community advocates. By federal law, all clinical trials must be approved by an IRB. The IRB will review the proposed trial weighing the potential risks and benefits and making sure that the rights and health concerns of trial participants are protected. Once approved, a clinical trial can be conducted and the research will be subject to periodic reviews by the IRB.

Clinical trials and primary health care

Most clinical trials provide experimental treatment directed at a specific health issue and do not provide general primary health care. A participant should continue to receive primary health care from his or her primary health care physician. The primary health care provider should be aware of the clinical trial and work with the clinical research team to ensure that there are no conflicting treatments.

Can participation in a clinical trial be terminated before the trial is finished?

Yes. A participant in a clinical trial is free to discontinue participation at any time.

How do clinical trials originate?

Clinical trials are usually proposed when researchers have identified promising new drug therapies or medical procedures. The new ideas usually result from laboratory and animal tests and the clinical trial is the next step in assessing the efficacy of such treatments for humans. The clinical trial will address several aspects of the experimental treatment such as potential risks, methods of administration, dosages etc.

How are clinical trials funded?

There are many different private organizations and individuals as well as government agencies that sponsor clinical trials. These organizations include medical foundations, philanthropic organizations, pharmaceutical companies, the National Institute of Health (NIH), and the Department of Defense (DOD). Clinical trials can be conducted in universities, hospitals, doctor’s offices, and clinics.

Terms used in Clinical Trials:

Protocol- the detailed plan to which the clinical trial adheres. The protocol establishes such things as:

• Who qualifies to participate in the trial
• The duration of the trial
• The schedule of procedures and check-ups
• The schedule and dosages of medications

Control Group- a group of participants in a clinical trial that does not receive the new treatment being studied and which is compared to the group of participants that does receive the new treatment. In some clinical trials the control group will be given a placebo.

Placebo- an inactive substance containing no medication. A placebo is often given to the control group of a clinical trial in place of the experimental treatment being given to the other participants in the trial so that comparisons can be made.

View the Clinical Trials Glossary

There are several types of clinical trial

Treatment trials test new medical, surgical, and/or radiation treatments for combating illness.

Prevention trials test methods for preventing first time occurrences or recurrences of diseases. Methods could include medical treatment, diet and lifestyle changes, dietary supplements, exercise, and vaccines

Diagnostic trials look for new or improved methods for diagnosing a particular disease or condition.

Screening trials look for new or improved ways to detect a particular disease or condition.

Quality of Life or Supportive Care trials look for ways to improve the quality of life for individuals with a chronic illness.

There are four phases of clinical trials:

• Phase I trials are the first testing of a new treatment. A small group of participants is used (20-80). Researchers try to determine safe dosages and look for side effects.
• Phase II trials involve a larger number of participants (100-300). Researchers evaluate the effectiveness and safety of the treatment and continue to look for side effects.
• Phase III trials further increases the number of people receiving treatment (1000-3000). Researchers evaluate the effectiveness and safety of the treatment and continue to monitor side effects. Researchers compare experimental treatment to other available treatments with regards to these and other factors.
• Phase IV trials are post-marketing evaluations of the treatments risks, benefits and how it can be used most effectively.