Clinical Trials: A HealthCentral Explainerby Erica Sanderson Editor
Every new medication, device or procedure must first be evaluated in a clinical trial. This step is an integral part of the medical and health care process. Here’s how clinical trials work, how someone can get involved and why they’re important.
Understanding clinical trials
A clinical trial is the process in which researchers and scientists test types of medications, treatments, devices and procedures in a controlled environment to be approved for public use. The U.S. Food and Drug Administration (FDA) regulates all medical drugs and treatments in America. If a drug or treatment does not pass the phases of a clinical trial regarding safety and effectiveness, the FDA will not approve its availability on the consumer market.
Before being tested in a clinical trial, any new treatment is thoroughly studied in a laboratory. If initial research indicates the treatment could be successful in humans, the results are submitted for review and funding to begin the clinical trial. Most clinical trials are registered and tracked through clinicaltrials.gov.
Location and duration of clinical trials vary. They can last months or years and usually take place at hospitals, universities, doctors’ offices and clinics. Further details are provided to participants before the study begins. Most trials are usually sponsored or funded by pharmaceutical companies, academic medical centers, federal organizations, health groups and other organizations or even individuals.
There are different types of clinical trials based on the objective of the experiment. Interventional trials test new treatments that aren’t yet available on the consumer market while prevention trials target reducing the risk of a certain condition. Observational trials monitor health issues in large groups of people while screening trials involve procedures or tools for diagnosing and detecting conditions.
The majority of trials are “blind”-- participants are not informed of the variables to prevent any biases that would influence the results. Studies can either be single or double-blinded. A double-blind study means neither the researchers nor the participants know who received the treatment and who received the placebo until after the trial is completed. A placebo, usually a sugar or water pill, has no active elements and is used as a constant for comparison. A single-blind study is when the researcher knows which participants received the placebo or treatment, but the participants do not.
Clinical trials require volunteers, though the type of volunteer varies for each study. Some clinical trials want healthy participants, others need people with a specific disease or condition and some select a predetermined group of people.
Healthy individuals can sign up to participate through the National Institute of Health’s Clinical Research Volunteer Program. This program was created in 1995 to find the best match for a healthy volunteer and clinical trial. All studies involving humans must first be reviewed and approved by the Institutional Review Board (IRB) or another type of review board. These boards comprise a group of people who oversee any research at a given institution and ensure the research experiments are safe for individuals to participate.
There are many benefits for volunteering, particularly for participants who have a condition. Patients are exposed to groundbreaking treatments that can improve their symptoms or disease severity. They also receive greater care and observation than normal while helping improve future treatments for people with conditions.
Some clinical trials offer monetary compensation for participants’ time and effort. As with any experiment, there is potential for risk. Depending on the trial, there may be serious or life-threatening side effects. These risks will be outlined in a consent document to participants prior to joining.
Why are clinical trials important?
Clinical trials are an essential step in medical and health care. Without them, treatments would not be tested for safety and could have life-threatening effects. These experiments hone in on what works or doesn’t work to provide the highest quality treatment possible for patients to improve their conditions and—in some cases—prolong lifespans.
New research findings and medical breakthroughs would be extremely limited without clinical trials. Trials help prevent the spread of certain diseases and leads to the discovery of illnesses, thereby educating the public, raising awareness, and saving lives.