Pharmacology Clinical Trials

Introduction

The process that brings a new drug from the research laboratory to the marketplace is a long and careful one. Long, because it takes years to complete all the laboratory, animal and human tests; careful, because all those involved in bringing it to market must follow strict government regulations regarding the drug's safety and how well it works.

One of the most important steps in the development process is the clinical trial, which is a study with people like you who volunteer to receive the drug and be observed for its effects. It is through these trials that investigational new drugs are tested to determine whether they can benefit human beings. But before this can happen, people must volunteer and participate - a choice that may benefit not only the individual but many, many others as well.

Whether or not a clinical trial is right for you depends on a number of factors, including your medical condition. Your physician will discuss these factors with you and provide all of the information available on the drug and the trial itself.

Still, you may have questions. Participation in a clinical trial can be a great undertaking, and there are no guarantees that the drug will work. This page, however, will help you understand the benefits and risks of participation, and give you some idea of what to expect if you decide to participate.

What is a Clinical Trial?

A clinical trial is carefully supervised research that is done in humans prior to the release of a drug to the general public.

The term clinical refers to research performed in a hospital or clinic setting in which a physician and other health care professionals observe a patient. A trial is a study, whereby the drug is analyzed for its effects on a group of patients.

However, before a drug enters the clinical trial phase, it is extensively tested through basic or preclinical research in the laboratory, both in lab experiments and in animals. The type of experiments depends on the disease being studied, and if animals can also have the same disease. This type of research is extremely important in gathering information on the drug's possible benefits and limits before it is tested in humans.

It is important to understand that both basic research and research done through clinical trials are carefully supervised, monitored and documented. New drugs must demonstrate their safety and efficacy to government regulators (such as the F.D.A. in the United States) before they take their place on the pharmacy shelf. Clinical trial volunteers play a very big role in this process.

Why Do People Become Involved in Clinical Trials?

The reasons why people become involved in clinical trials are as varied as the individuals themselves.

Some people have an illness, which currently has no treatment. A clinical trial may offer the opportunity to try a new investigational medication, which may help.

Some may become involved because their current medication has too many side effects and they want to see if they can tolerate the drug being tested.

Others may want more interaction with health care providers to discuss their medical condition.

And others volunteer because they want to help find answers to scientific or medical questions that will help others benefit in the future.

Only you can decide whether or not a clinical trial is right for you. That's why you should take plenty of time to think about the trial and ask all the questions you want. You may even consider asking a close friend or family member to help you in your decision—they may have questions or concerns that you may not have considered.

Above all, remember that there are risks associated with clinical trials. And yes, it's a tough decision. Have all the facts before you make up your mind.

"I decided to enter a clinical trial because I felt I would be receiving advanced treatment and hoped that any documentation would be of help to future patients."

—Patient