What is a clinical trial?
  • Mon, 07/23/2012 - 3:13pm

With all the stories in the news about the U.S. Food and Drug Administration approving various pharmaceutical drugs, we thought you might have a few questions. For instance:

What is a clinical trial?

The FDA website defines a clinical trial as an investigation in which researchers study human volunteers in order to gather data that answers a particular health question. During the study, types of patients, dosages, side effects and other factors are explored and noted.

Types of clinical trials include:

  • prevention options
  • new treatments or alternative employment of established treatments
  • new screening and diagnostic methods
  • ways to improve the living conditions for patients with severe medical afflictions

Why are they used?

Clinical trials often test a recently developed drug or medical device to ascertain its safety and usefulness for patients, according to the FDA website. Clinical studies also examine the benefits of established treatments versus the benefits of new treatments to ensure patients receive the best possible treatment.

The FDA says some clinical trials study alternative ways to employ established treatments to make them more useful and efficient or to reduce the side effects of the treatment. Others provide researchers with an environment in which they can understand the most effective way to use treatments in other populations, like children.

Are they safe?

Researchers, doctors and other health professionals must follow the rules the FDA created to ensure the safety of people participating in clinical studies, their website says. Although they try to limit the risk factors involved in clinical trials, the FDA states some risk may be inevitable in studies that look at new treatments.

The FDA goes on to say that each study must also follow a protocol that explains what researchers may and may not do in the trial. For example, a protocol designates the patients that the researchers can enroll in the study, the timetable of the tests and procedures, the drugs used, the dosages, the duration of the study and how the data will be measured.

Also, every person in a clinical study must consent to the guidelines described in the protocol, the FDA says.

How can I find out about new clinical trials?

The FDA website lists clinicaltrials.gov as a reliable source of information concerning current clinical studies. Overseen by the National Library of Medicine, the website is an interactive database that presents information about federally and privately aided clinical trials involving human volunteers.

If you have any questions we have not answered, we encourage you to ask them below.


About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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