Taking the mystery out of clinical trials: 5 things to know
You may be surprised to learn that the world’s first celebrated clinical trial began on board a British naval ship nearly 300 years ago. It led to the discovery of a life-saving treatment for sailors dying from scurvy.
“Countless medicines, therapies, devices and procedures have been discovered and are available for use today because of clinical trials and the millions of people who have volunteered to participate,” said Nina Garlie, vice president of clinical trials research at Advocate Aurora Research Institute. “While research remains an unfamiliar territory for many, it doesn’t have to be.”
To help take the mystery out of clinical trials, here are five key things to know.
- Why clinical trials are so important: Reliability. Clinical trials are the gold standard for verifying the safety and effectiveness of new medical treatments and testing new ways to prevent, detect and diagnose diseases. Many safeguards are put in place to eliminate bias, preference and opinion and to make certain that clinical trial results are based on strict scientific evidence
- Why people join clinical trials: People become research participants for multiple reasons. Healthy volunteers may join clinical trials to help prevent or find a treatment for a disease affecting family members. Others may join because they are living with a medical condition that has no treatment, and a clinical trial provides both hope and the chance to regain health or quality of life. Still others may join to help improve our knowledge of rare diseases, discover better treatments or investigate new therapies that may lead to a cure. Regardless of the reason, every research participant contributes to medical advances that ultimately improve the health of future generations.
- Participants are protected: Federal laws and agencies have been established to protect research participants and regulate how clinical trials are conducted. And before participants may join a clinical trial that tests a potential treatment, approval must first be given by a diverse group of people who work together to protect the rights and welfare of research participants. This group, named the Institutional Review Board, continues to monitor and oversee the clinical trial until it’s closed.
- Power is with the participant: Participation in clinical trials is voluntary. Researchers prepare a written document, called a consent form, that explains the risks, possible benefits, and other major details about the clinical trial, such as if any additional procedures are required, the length of time participants are asked to remain in the trial, and how to get in touch with the research team at any time. Before deciding to join, participants are given the opportunity to carefully review the consent form and ask questions. Even after joining, participants are free to leave the trial at any time.
- Participants are never alone: The research team supports participants throughout the entire trial, monitors their health, and addresses any questions or concerns. One of the team members, the research coordinator, helps participants to stay on track with scheduled treatments and research visits. Coordinators also maintain communication between the participant, the research team and the participant’s other health care providers.
About the Author
Lorene Schweig is medical writer at Advocate Aurora Health. She has a background in both nursing and research and received her master’s degree in written communication from National Louis University.