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Feature:
Clinical Trials

Clinical Trials, A Healthier Future for All

Did you know that most anyone can get involved with clinical research? No matter if you’re healthy, sick, young, or old, you may be able to help scientists find treatments or cures. Clinical trials, also known as clinical research or clinical studies, offer hope for many people with a health condition or illness.

Helping Yourself and Helping Others

If you or a loved one has a condition, you may be able to help test a new drug, device, or intervention. While participating in a clinical trial may not result in direct benefits to your health, the knowledge developed may help others. If you’re a healthy volunteer, you can help scientists learn more about how the body works or how to prevent an illness. Either way, it’s a chance to potentially help yourself and help others.

Medical care is better today thanks to clinical trials from the past. It will be better tomorrow as a result of clinical trials going on today.

There are different types of clinical trials:

  • Natural history studies provide valuable information about how disease and health progress.
  • Screening trials test the best way to detect certain diseases or health conditions.
  • Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
  • Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.

Before a new medical treatment or medication can be given to the public, it has to pass through clinical research studies. These are designed to test if it works and if it is safe.

Participation by many people is important because medical treatments may affect different racial or ethnic groups in different ways.

The Process

A clinical trial closely follows a protocol—the process that will be followed throughout the trial. The protocol clearly defines who can participate, how long the study will last, and what information will be collected. It also tells the research team, and you, what tests, procedures, medications, and dosages are involved.

Clinical trials are conducted in “phases.” Each phase has a different purpose and helps researchers answer different questions.

The first phase of a clinical trial involves a smaller group of people, usually less than 100. If no major problems occur at this stage, the treatment is tested on larger groups of people in Phase II and Phase III trials, usually including patients with the condition.

After a trial, the information is analyzed to see if the treatment, intervention, or medication is better, worse, or about the same as what is currently available. Once the Food and Drug Administration rules on the safety and effectiveness of a treatment drug, it is made available to the public.

Protections

If you’re thinking about joining a clinical trial, the research team will tell you about the details of the study and and what your involvement would mean before getting your informed consent. This is a signed document that details the study, it’s purpose, length, processes, risks, and who to contact for more information. You should be well informed and feel confident and secure about participating.

Before you enroll in a clinical trial, you may have to take screening tests to see if you are able to participate. These tests are designed to exclude those who may not benefit from, or may be harmed by, the treatment.

Most, but not all, clinical trials in the U.S. are approved and monitored by an Institutional Review Board (IRB). An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that the trials are ethical and that your rights are protected. Ask the sponsor or research coordinator whether the trial you want to participate in was reviewed by an IRB.

Find a Clinical Trial Near You

Health research takes place at hospitals, universities, doctor’s offices, and community clinics across the country. Much of the research is conducted through the National Institutes of Health, which currently supports nearly 224,000 studies in all 50 states and in 192 countries.

If you are interested in participating in a clinical trial, visit U.S. National Institutes of Health Clinic Trials registryOpens new window at clinicaltrials.gov to see what is being studied in your area and regarding your condition. Your doctor can help you decide if a trial makes sense for you.

Need for Inclusion

More members of minority groups are needed to participate. For example, African Americans make up about 12 percent of the U.S. population, but only five percent of clinical trial participants. Hispanic/Latino Americans make up 16 percent of the population, but less than one percent of participants in clinical trials.

Participation by many people is important because medical treatments may affect different racial or ethnic groups in different ways. Clinical trials are designed to measure these variations, so it’s very important to have diversity.

Read More "Clinical Trials" Articles

Clinical Trials, A Healthier Future for All / Meet Clinical Trial Participants / North Carolinians Volunteer for Knee Pain Study

Fall 2016 Issue: Volume 11 Number 3 Page 16-17