Clinical trials are experiments designed and executed by researchers, called investigators, to test new drugs, therapies and devices on human participants before they are submitted for approval to the FDA or marketed and sold for use by general patient populations.
Before they are conducted with humans, they are tested with laboratory animals like mice or rats. When they seem to improve either the diagnostic process or the status of the animals' health, and are deemed to be safe for those animals, then the testing moves to humans through development of clinical trials.
If you are considering participation in a clinical trial, there are a number of steps you'll want to take to be sure you will benefit from the trial, and the clinical trial will benefit from your participation.
- Be sure to understand exactly what a clinical trial is, and how they are conducted. There are several different types of trials, and four different phases of trials in which you might participate.
- Identify a clinical trial which will benefit you, and which will benefit from your participation. (see below)
- Determine whether you are eligible to participate in the clinical trial you have identified by reading a description of the participants the investigators are looking for. Criteria for participation may be medical or social, and may include any or all of the following: age, gender, race, diagnosis, the type and stage of a disease, previous treatment history, other medical conditions (comorbidity), location or others. Any of these criteria may be used to include or exclude a participant.
- Understand the risks and benefits of participation in a clinical trial, and specifically the trial in which you are interested. Not all trials result in good outcomes, but many do. There may be some good reasons for you to participate, and there may be some detriments of which you'll need to be aware.
- Meet with your trial's investigators to ask questions about your intended trial. The questions will help you weigh the risks and benefits of participation both in terms of the trial itself, and how it will affect your daily life, and your life in the long term.
From understanding possible outcomes, both positive and negative, to knowing how much it will cost, whether you'll need to be hospitalized, and how far you might have to travel, be sure you understand the answers to the questions before you give your consent to participate.
- Be informed before you give consent to participate in the trial.
Where to Find a Clinical Trial In Which You Can Participate
Clinical trials take place across the globe. The following websites can provide you with listings of current and future trials:
- From the US Government and National Institutes of Health
- From the World Health Organization
- From CenterWatch (This site includes a notification service.)
- Cancer trials from the National Cancer Institute