Many have heard of clinical research in the medical industry, but what goes into researching diseases like cancer and how are the results determined? What are clinical trials and who do they involve?
What are Clinical Trials?
Clinical trials are tests done by researchers to evaluate the safety of new therapies and how effective they are at treating certain diseases or conditions, such as cancer. The FDA (Food and Drug Administration), a government agency that regulates the use and testing of new drugs before they are released to the public, must evaluate and approve the safety of any new drugs. There are different types of clinical trials depending on the purpose of the drug or therapy:
Screening trials - these trials test the best and most accurate ways to detect a disease or condition through methods like blood tests, mammography, and MRI (magnetic resonance imaging)
Treatment trials - these trials evaluate drugs like pain medicines, treatments like radiation or steroid injections, and new ways of performing surgeries
Prevention trials - these study medicines, vitamins or forms of exercise to determine if they help lower risks of developing certain diseases
Quality of Life trials - study the benefits of certain lifestyle changes (like change in diet) that can help improve the quality of life of a person
What Happens in a Clinical Trial?
First, a sample of volunteers meeting specific criteria are chosen through a process called inclusion/exclusion criteria. Determining who meets the criteria for a certain trial may be based on disease type, age, sex, race, or a number of other factors. There is also a list of factors that excludes any individual who meets those from participating in the study.
In a phase called “randomization,” the chosen participants may be divided into two groups to be tested individually and compared to the other group. The participants might not be aware of which treatment their particular group will be receiving. This is to avoid what’s called the “placebo effect,” something that may happen when a participant recognizes symptoms of the drug that are not really there based upon preconceived notions.
Results are then gathered and analyzed to determine the effects the drug had on each group. Researchers’ findings are reported to the FDA. If approved, the FDA will then list all side effects, the recommended dosage, and which specific patient type that the drug is meant for.
Enrolling in a Clinical Trial
Volunteers who would like to enroll in a clinical trial study will receive a written consent form explaining the study and informing them of any possible risks and benefits of participating. They are given information like what overall experience they can expect during the trial, the purpose of the trial, who the researchers or study sponsors are, and that they have the right to withdraw from the study at any given time, even after the consent form has been signed.
If you’re interested in learning more about what kinds of clinical research Compass Oncology offers, visit the Clinical Trials and Research page where you will find frequently asked questions, available clinical trials in Portland and Vancouver, and more.