Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever.
Drug and device testing begins with extensive laboratory research which can involve years of experiments in animals and human cells. If the initial laboratory research is successful, researches send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans.
Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase. For more information in regards to the phases of human clinical research, please click here (should hyperlink to SubTab 3.1)
A clinical trial’s main goal is to learn, not to treat. Researchers worldwide utilize clinical trials to assess the efficacy of medications in comparison to placebos or other treatments. More so some clinical trials will be testing various treatment regimens of existing medications. All this information is available to you upon request for any study you may wish to participate in.
Why are clinical trials done?
Clinical trials are conducted for many reasons:
- To determine whether a new drug or device is safe and effective for people to use
- To study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects
- To learn how to safely use a treatment in a population for which the treatment was not previously tested, such as children.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called “inclusion criteria” and the factors that disallow volunteers from participating are called “exclusion criteria.” These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants’ safety, and ensure that researchers learn the information they need.
Is it safe to participate?
The FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.
How much will it cost?
Nothing nor do we go through your insurance or ask for your ID. Most if not all, clinical trials provide reimbursement for your time and travel associated with the study.
For full information related to the risks and benefits of participation in a clinical trial, please visit www.clinicaltrials.gov.