Participants, also referred to as volunteers or patients in clinical trials, are what power clinical research. With the help of these volunteers, researchers can further the advancement of drugs, medical devices, novel surgical procedures, diagnostic tests, gene therapy, or find different ways to use existing treatments, to improve the quality of life for people all over the world. Participants may find many benefits to participating in clinical trials, such as access to cutting-edge treatments or exceptional healthcare providers, but before deciding to enroll in a clinical study, potential participants should understand what clinical trials entail and why they are important.
What is a clinical trial?
Clinical trials are the vessel to developing clinical research programs and drive the advancement of medicine. The core objective of a clinical trial is to find new and improved methods of treating, preventing, screening for, and diagnosing different health concerns. Human volunteers, also known as participants, work with doctors and researchers to evaluate new medical treatments, drugs, devices, novel surgical procedures, diagnostic tests, or gene therapy. This makes it possible to apply the latest scientific and technological advances to patient care.
What do the different phases of clinical trials mean?
Clinical trials are conducted in phases. Each new phase of a clinical trial builds on the information collected from the previous stage. Participants may be eligible for clinical trials in different phases, depending on their overall condition. Most participants take part in Phase III and Phase IV trials.
- Phase I: This is the beginning of a new research treatment that is given to a small number of participants and emphasizes safety.
- Phase II: This phase determines the effect of a research treatment on the disease or condition being evaluated.
- Phase III: This phase compares the new treatment with the standard treatment and studies the different populations and dosages.
- Phase IV: This phase applies the new treatment to the general patient (after FDA approval for marketing).
Who can participate in clinical trials?
Each clinical trial will vary on who is deemed eligible to participate. Every clinical trial is designed to meet specific research criteria to match the certain condition or symptom researchers are investigating. Some clinical trials will enroll people who have been diagnosed with a specific disease or condition. Others may enroll healthy participants to test new approaches to prevention, diagnosis, or screening.
What is it like to participate in a clinical trial?
All participants will face a new multitude of medical terms and procedures. Fears and myths about being experimented on are common concerns for participants who are considering joining a clinical trial, and while there will always be fears of the unknown, making sure you understand the procedures and what is being asked of you prior to joining a clinical trial will help alleviate some anxiety.
However, most clinical trials in the U.S. are approved and monitored by an Institutional Review Board (IRB) to ensure that the risks of the trial are reduced and outweighed by the potential benefits of the treatment. IRBs are independent committees responsible for reviewing research to protect the health and safety of clinical trial participants, both before and during clinical trials. Potential participants should always ensure that the trial they are considering has been reviewed by an IRB before joining.
Why should I participate in a clinical trial?
People participate in clinical trials for a variety of reasons. Some may want to play an active role in their personal health by gaining access to cutting-edge research treatments. Some may want to help others by contributing to the advancement of medical research. Others may be seeking decreased costs for treatment of a disease, as many of the tests and doctor visits that are directly related to the clinical trial are paid for by the group sponsoring the study.
Regardless of the reason why an individual chooses to take part, clinical trials offer hope for many people and an opportunity to assist researchers to find better treatments for future generations.