by Norma Chew

Created on: April 12, 2009

According to Pfizer, one of the world's largest sponsors of clinical trials, "clinical trials are one of the most important steps in the research process." A clinical trial is defined as a medical investigational study with human volunteers to get answers about new medicines and treatments. A clinical trial gives researchers better ways to treat, prevent, diagnose, screen and/or provide better quality of life to patients.

Types of Clinical Trials

There are five types of clinical trials.

Treatment

A treatment trial tests new treatments, new combination of drugs, and new approaches to surgical and radiation treatments.

Prevention

A prevention trial finds new ways to prevent diseases through the use of medicines, vitamins, vaccines or through life style changes.

Diagnostic

In a diagnostic trial a new and better way is tested to diagnose a particular disease.

Screening

A screening trial tests ways to detect for a particular disease.

Quality of Life

A quality of life trial tests for a way to improve the comfort and the quality of life for people living with chronic diseases.

In the United States, the National Institute of Health, (NIH) and the U.S. Food and Drug Administration has established strict rules and regulations with scientific and ethical principles that must be followed in conducting a clinical trial.

Every clinical trial has a protocol or plan of action regarding the process of the trial.

A federally funded clinical trial regarding the evaluation and testing of a new drug or medical device subject to the Food and Drug regulations must be approved by an Institutional Review Board. (IRB.)

The Institutional Review Board is a committee of medical experts, doctors, nurses, researchers, community leaders and members of the community. Their role is to ensure the safety and fairness of the trial.

There are guidelines and protocols regarding who may participate in a clinical trial.

An informed consent is required. The consent ensures that you know and understand the facts, the purpose, the protocol, the requirements, tests, procedures, risks and benefits included in the trial. Signing the consent does not mean you have to stay in the trial, your participation is always based on your desire to volunteer.

It is important to know that there are risk as well as benefits to participating in a clinical trial.

Some Risks are:

Side effects pertaining to the drugs or procedures used in the trial.

There is a chance you may receive a placebo or the standard treatment instead of the investigational treatment. A placebo is an inert medication or treatment given to a control group in a clinical trial instead of the investigational treatment.

Some Benefits are:

The opportunity to be under the care of a team of top researchers.

The privilege to have new treatment before it is available to the public.

The cost of the treatment is usually covered by a pharmaceutical sponsor or the federal government.

The opportunity to help medical researchers to find ways which will benefit other patients in the future.

Would You Like to Participate in a Clinical Trial?

Talk with your physician who can inform you of current clinical trials and some general information about clinical trials.

Contact a medical center in your community and enquire about their clinical trials available.

Research the Internet for pharmaceutical, Medical Center and the National Institute of Health web-sites for information re clinical trials.

Clinical trials have been important in the medical and technological advancement of patient care in the past, now and will continue into the future.
www.clinicaltrials.gov

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