A clinical trial is a research study that helps answer questions about human health and develops new treatments for disease. These advances in health care are made possible by volunteers who participate in the study. Clinical trials may test drugs, medical devices or other treatment interventions to determine whether they are safe and effective for human use. Clinical trials are highly monitored and regulated to ensure that the rights and well-being of research participants are always considered.
When you participate in a clinical trial, you may gain early access to the latest treatment options for a disease — options otherwise not available.
You may also participate in a study that aids in the development of a new treatment option for others. While the outcomes of the studies are varied, and curing a disease is not guaranteed, you make a significant impact by participating in the process.
Before joining a clinical trial, you must qualify for the study. Some studies look for participants with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Some studies need both.
- “Healthy volunteers” are participants who are in good health and can help test a new drug or device that has never been given to people or to only a few people. A healthy volunteer is given an intervention to build new knowledge about it and to see if people can safely use it. Results from healthy volunteers are compared to results from patient volunteers who do have the disease or condition.
- “Patient volunteers” have a known health problem, and they participate in a study to better understand, diagnose, treat or cure that disease or condition. Patient volunteers may also participate in studies testing drugs, devices or other interventions designed to prevent or treat disease. In some studies, patient volunteers may be put into a group to take an inactive drug, or placebo.
- Diagnostic studies help find better ways to diagnose conditions
- Investigational intervention research investigates the most effective and cost-efficient interventions (such as medications, devices, etc.) to address human illnesses
- Outcomes research seeks to understand the end results of particular health care practices and interventions
- Prevention studies seek to determine ways to prevent human illness, or to prevent illness from recurring
- Quality-of-life studies improve the way those with chronic illnesses integrate the care of their illness into their daily lives
- Screening studies find new ways to determine if someone has a certain illness or disorder
Make sure to discuss any questions or concerns when considering participation in a clinical trial, including:
- If I am ill, will this research help me?
- What are the long-term and short-term risks?
- What is involved? What will I have to do?
- How long will the study last?
- Will I be charged anything or compensated for my participation?
- How can I end my participation if I change my mind?
- What will happen when the study is over? Will I be told the results?
- Who can I contact with any concerns along the way?
Informed consent ensures our research participants are fully informed about the purpose, risks, benefits, requirements, procedures and duration of a trial. The study staff will review a written informed consent document with you before signing the document. After signing the document, study staff must continuously inform you of any changes to the study that might impact your participation.
There are risks and benefits to each clinical trial, all of which are discussed in the informed consent document. Some clinical trials may be relatively risk-free, while others may have a higher risk or may place burdens upon participants. Study staff will talk with you about any questions or concerns you may have about the potential risks of your clinical trial.
After a clinical trial is over, researchers carefully look at the information collected during the study to determine the intervention’s effectiveness, if it is safe and if there are any side effects. Depending on the results, scientists then decide whether to stop or continue testing the new intervention. If scientists find the results are medically important, they may submit them to journals or scientific meetings for review by others in their field.
Results are also shared with government agencies in charge of the approval for new drugs, devices and other treatments, such as the FDA. If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug’s safety, effectiveness and cost to other drugs already on the market or assess its long-term effectiveness and impact on quality of life. Once a new approach has been shown to be safe and effective in a clinical trial, it may become the standard of medical practice.
Additionally, after a clinical trial ends, patients may continue receiving the intervention if they are responding well. Generally, however, participation ends when the study ends because it might not be safe or effective to continue treatment based on what is known at the time.