Understanding Clinical Research

Central Dermatology has been participating in clinical research trials for over 15 years including trials with many of the medications currently used in the treatment of psoriasis, psoriatic arthritis, and acne. Below we have summarized the clinical research process that each drug must go through to be approved by the Food and Drug Administration (FDA).

• Introduction

Before a pharmaceutical company can initiate testing in humans; it must conduct extensive laboratory research in animal and human cells which can take years. If this stage of testing is successful, a pharmaceutical company requests approval from the Food and Drug Administration (FDA) to begin testing the drug in humans.

The clinical testing of experimental drugs is normally done in three phases, each phase involving a larger number of people than the previous one.

• Phase One:

Phase I studies are primarily concerned with assessing the drug's safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100). The study is designed to determine what happens to the drug in the human body and will investigate side effects that occur as dosage levels are increased. This testing typically takes several months and about 70 percent of experimental drugs pass this initial phase of testing.

• A Phase Two Study:

Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials meaning one group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Only about one-third of experimental drugs successfully complete both phase I and phase II studies.

• A Phase Three Study:

In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more complete understanding of the drug's effectiveness, benefits, and the range of possible side effects. Phase III studies typically last several years and 70 to 90 percent of drugs that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug.

• Post-Marketing -- Late Phase Three/Phase Four Studies

In late phase III/phase IV studies, pharmaceutical companies have several objectives: to compare a drug with other drugs already in the market; monitor a drug's long-term effectiveness and impact on a patient's quality of life; and determine the cost-effectiveness of a drug therapy compared to other therapies.

• Should you participate in clinical research?

People participate in clinical research for a variety of reasons. People who volunteer for phase II and phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They will get excellent care from our staff during the course of the study. This care also may be free or compensated, depending on the study.

Your rights and safety are protected in two important ways. First, any physician participating in a clinical trial must obtain approval to conduct the study from an Institutional Review Board composed of physicians and lay people. They examine the study's protocol to ensure that your rights are protected, and that the study does not present an undue or unnecessary risk to you. Second, anyone participating in a clinical trial is required to sign an "informed consent." This form details the nature of the study, the risks involved, and what may happen to a patient in the study.

If you are considering participating in clinical research, you should talk about it with your physicians and medical caregivers.

• Other questions to ask include:

• Need more information about clinical research?

The National Institutes of Health provides detailed information for patients considering participating in a clinical trial on their web site in the section entitled "An Introduction to Clinical Trials" and you can always contact our staff with any questions you have.