Clinical Trials | HealthInfi

Overview

A clinical trial uses human volunteers in planned research to increase medical knowledge. A trial look at an “intervention,” such as a drug, medical device, procedure or participants’ behavior (such as diet and exercise), to assess its merit. The researchers measure the effects of the intervention on the participants. The goal is to see if a new drug, device, procedure or behavioral modification is effective and safe.

For example, a clinical trial might look at the effects of a new drug on participants to see if it effectively and safely lowers high blood pressure.

There is another kind of clinical study, called an observational study, in which participants are also observed to assess health outcomes, but they are not assigned specific interventions, such as a drug or procedure. For example, researchers conducting an observational study might observe a group of older adults to see how exercise affects their cardiac health. (Find out more about observational studies.)

In the United States, research usually starts with lab experiments and sometimes with animal testing or computer modeling. This may be followed by clinical trials in humans.

Currently, more than 150,000 studies of drugs and other treatments are in active clinical trials in 185 countries. They may be done in cities and towns of any size and can be conducted at universities, community clinics, hospitals and doctors’ offices.

The federal government maintains a website called ClinicalTrials.gov that provides information on publicly and privately funded clinical studies of drugs, diseases and conditions. The site has information about what trials are being conducted or coming up and which ones are seeking participants.

All clinical trials must have a study design plan called a protocol. This plan is presented to the U.S. Food and Drug Administration (FDA) as part of the Investigational New Drug (IND) application. The FDA and a research ethical review board or an institutional review board (IRB) must approve a protocol for each study site. After the study begins, the review board advocates for the volunteers. Anyone who volunteers to participate in a study must first sign a written informed consent, which says that you have been given information about the study and understand it. (Find out more about oversight of clinical trials and informed consent.)

Once a trial is completed, the results are examined by the FDA. Before approval is given, the clinical trial results of safety and effectiveness must be “statistically significant.” That means the results are analyzed to show that they are highly likely to be “true” and not the result of chance.

The process can take more than 10 years, and many new products and procedures never make it through the process and never reach the market.

Pharmaceutical companies also test drugs that have been approved to continue checking long-term safety and effectiveness. If the company wants to market the drug for new uses or add labeling claims, more clinical trials are required.

Reasons for Conducting Clinical Trials

Any question a health care professional might have about how best to diagnose, treat or prevent a medical condition may be addressed scientifically by a clinical trial. For example, a study might ask whether using a particular drug in addition to surgery is better than surgery alone or whether earlier, more aggressive treatment of a condition produces a better outcome. Trials are often used to compare a new drug’s safety and effectiveness to a placebo or to existing drugs used for the same purpose.Read More