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Wednesday, June 19, 2013
For many people, the concept of participating in a clinical trial is intimidating, frightening and unappealing.
But local physician-scientists will remind naysayers that anyone who takes a medication or has a medical treatment is able to do so because of clinical research. And that research was made possible because average people volunteered to participate in it.
There are three common public misperceptions about clinical trials that cause people to shy away:
One of the biggest myths out there is that clinical trials are only for people with no other choices. There are clinical trials for every stage of disease as well as prevention and early detection, and they all have value.
Clinical trials are the last step in a carefully regulated, detailed scientific process that starts in a laboratory in cells or tissue and is then tested in humans—oftentimes years later and always after strenuous review.
Medical studies are supervised by a local physician and look at every stage of disease, from first diagnosis to advanced disease. All are designed to find, diagnose, treat or prevent cancer.
Clinical trials exist to answer questions and allow us to learn better ways to treat specific diseases. It is the only way medicine can move forward. Every new drug must be studied to avoid unforeseen negative outcomes and avoid treatments that aren’t beneficial. Even though not everyone who participates in a clinical trial will receive the investigational therapy, everyone does get the same standard of care they would if they didn’t participate.
There are four basic types of clinical trials:
Before a patient is enrolled in a clinical trial, the individual is carefully screened against a set of criteria designed to create a group of people that are as similar as possible.
Qualification depends on a variety of factors including stage of disease, existing health conditions and other factors. The criteria for each trial are very specific to avoid including anyone in a trial that doesn’t fit.
The patient then goes through what is known as “informed consent” where the goals of the trial, why it is needed and how it will work are explained in easily understandable terms.
Patients should take the time to discuss all the details of a clinical trial with their doctor and family before agreeing to participate. It is important to keep asking questions until the patient is 100 percent comfortable with their decision to participate.
Those questions might include information about costs, time commitments, potential benefits as well as side effects. This may vary, based on where the new therapy or tool is in development and testing process (phases).
Stringent patient protections implemented to ensure safety and ethical conduct are monitored by an Institutional Review Board (IRB), a governing committee made up of physicians, scientists and members of the community responsible for scientific review and approval of all clinical research studies. Other medical monitoring groups are in place to ensure medical oversight and ethical conduct throughout the clinical research process.
It is important to note that if a new drug or therapy doesn’t show enough benefit to the target population in the early stages of human testing, it does not move forward.
The IRB is essentially a medical watchdog put in place to protect patients. They ensure that the medical risks are reasonable compared to the possible benefits of a clinical study.
For more information on clinical trials, visit www.cancer.gov/clinicaltrials.
Last Reviewed: Dec 02, 2008
Michael F Reed, MD
Assistant Professor of Surgery
College of Medicine
University of Cincinnati