A clinical trial is a research study done by physicians (study doctors) and medical professionals to evaluate treatments or procedures. Each study is designed to answer specific scientific questions and to find new and better ways to help patients.

Before new treatments are introduced to patients, they are carefully studied in the laboratory. After demonstrating significant positive results in the laboratory, a protocol or plan is developed to introduce the new treatment to patients. Every new treatment or procedure must be shown to be safe and effective before it is approved for general public use.

The clinical trial is the part of the research process which involves patient participation. During a trial, researchers learn more about the new treatment, its risks, its benefits, and how well it may or may not work.

Researchers study new treatments that they believe will be as good as, or better than, the standard treatments currently available. Every advance in medicine is a result of new ideas which are developed through research.

Through clinical trials, researchers determine which treatments are more effective than others. These trials help to find new and improved ways to help patients. The majority of many standard treatments used today were first introduced to patients in clinical trials.

All of the laws and ethical codes that govern medical practice also apply to clinical trials. Clinical trials also have safeguards designed to protect patients. These safeguards include periodic review of each study plan and progress of the trial by the investigator, pharmaceutical personnel and medical experts.

All federally regulated clinical trials must be reviewed and approved by an Institutional Review Board (IRB). IRBs have a specific function in clinical research: they represent the best interest of the patients or healthy volunteers who serve as research subjects. The responsibilities of IRBs include:

• Review of proposed research to ensure that the potential benefits outweigh the risks to participants;
• Ensuring that the rights and welfare of study subjects are safeguarded, including both the fairness of selection procedures and proper management during the conduct of the study;
• Ensuring that all appropriate steps needed for true informed consent are planned and carried out.

Some of the benefits you may receive for participating in research projects are as follows:

• A better understanding of your condition;
• Closer monitoring of your problem, which enables the physician to treat you more effectively;
• An opportunity to receive the benefits of a new medication or medical device before it becomes generally available;
• Extra office visits, brief physical examinations, laboratory test, study medication and/or equipment at no cost to you;
• Reimbursement for the time and effort spent during the study.