What is a clinical trial?

A clinical trial is a type of research study. The most commonly performed clinical trials evaluate new drug, medical device, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority (in the USA, the Food and Drug Administration) approval of new therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions.

(http://en.wikiperdia.org/wiki/Clinical_trials)

What is the process of drug development?

The process of drug development consists of five phases.

Pre-clinical phase: After a substance or compound is developed, extensive laboratory research is conducted and the product or compound extensively tested in animals and human cells. An approval is sought from the FDA (Food and Drug Administration) by the pharmaceutical company to initiate testing in humans.

After the FDA approves testing in humans, Phase I is where investigation on the safety of the new drug in the human body begins. Since this will be the first time the drug is being tested in humans, its sole purpose is to examine how the drug is absorbed, metabolized, and excreted in the human body. A group of 20-80 healthy volunteers is selected during this phase.

If the drug passes Phase I, the trial will then proceed to Phase II. Since the drug is tested to be safe, the number of volunteers, who meet the targeted criteria for the trial, is increased. The volunteers are randomized to different treatment arms, which include the drug currently being investigated, a drug that has already been approved by the FDA, and a placebo or inactive drug.

Phase III studies are randomized controlled trials on large patient groups (300-3,000 or more depending upon the condition) and are aimed at being the definitive assessment of the efficacy of the new therapy.
(http://en.wikipedia.org/wiki/Clinical_trials)

Phase IV: It is the post-marketing safety surveillance and ongoing technical support of a drug. It is designed to detect any rare or long-term adverse effects over a large patient population and timescale than was possible during the initial clinical trials.
(http://en.wikipedia.org/wiki/Clinical_trials)

What are the benefits of participating in a clinical trial?

There are many ways a volunteer benefits from participating in a clinical trial. A volunteer will be able to have access to a drug or device that is not currently available to the public. The treatment may improve the participant’s current condition. By participating, volunteers will be able to help promote advances in medical science and may help others with the same ailment.

What are the risks of participating in a clinical trial?

There are risks when participating in clinical trials. Most studies are placebo-controlled; therefore a clinical participant may or may not receive the active drug. If the participant receives the placebo instead of the active drug, it is most likely that there will be no improvement in his or her condition. In some cases, there may be side effects associated with the investigated drug.

Will it cost me anything?

There is no cost in taking part in a clinical trial. All study-related tests and procedures are usually provided at no charge to participants.

Will my insurance be billed?

No, your insurance will not be billed for any study related treatment or procedure.

Is my study participation confidential?

Any information collected about the participant will be kept strictly confidential. Data collected during the study will be identified only by the participant’s initials and a number to maintain his or her anonymity.