Each year, millions of people consider participating in clinical trials. Many have preconceived ideas about what to expect. Nearly all of them have questions. It’s important to know the facts so you can decide if joining a research study is right for you.
Myths are widely held false beliefs or ideas. Take a look at some of the common myths about clinical trials along with the real facts to help you learn more about taking part.
Myth 1: I’ll be treated like a human guinea pig.
As a patient volunteer, you can be assured the doctors and nurses involved in the clinical trial will view you as a person with a health condition — not simply as a set of symptoms. They follow strict guidelines and will monitor your safety and well being, adjusting study-related care when it’s in your best interest.
Myth 2: I will receive a placebo instead of actual medicine.
You’ll know before you begin the trial whether or not getting a placebo will be a possibility. While a placebo does not have any sort of useful medicinal effect on the human body, it is often used in some clinical trials so that researchers can better compare the true overall safety and effect of the product being studied.
Myth 3: I’ll have to give up my current treatment to participate.
Some clinical trials allow you to continue with your current therapy; others do not. You can work with your primary care provider in order to figure out the best option for you.
Myth 4: Everyone will know I’m taking part in a drug study.
There are strict legal and ethical codes that must be followed during clinical trials. The data collected are de–identified and while the results of the trial may be shared with various medical journals and government agencies, your name and all of your individual study results will never be publicly associated with the trial without your consent.
Myth 5: The selection process is unfair.
Many trials limit participation based on a variety of factors, such as age and stage of the disease. These are guidelines used to determine the population for the study, and who will help the researchers determine the best treatment possible. For some investigational product, “expanded access” may allow you to receive the treatment even if you do not qualify for the trial.
Myth 6: I will know all possible anticipated and unanticipated harmful effects before I participate.
There are risks associated with clinical trials. The side effects and all known harmful effects will be explained to you by the study team before you decide to participate. While there are many safety assessments built into the clinical trial to protect participants, it is possible, however, that potential unanticipated effects could occur.
Myth 7: I must pay the cost since the medicine is experimental.
In most cases, you won’t experience any increase in what you would normally pay for care. In clinical trials, there are two types of costs: research costs and patient care costs. Research costs are typically covered by the sponsor of the trial, and many health insurers pay for costs that are not covered by the research sponsor. These are typically costs for routine patient care and non-experimental care such as office visits to the doctor, physical exams, tests, etc. All expected costs will be outlined in the informed consent.
Myth 8: I won’t have the option to leave the clinical trial.
Before you begin a clinical trial, you sign an informed consent document. By giving your consent to be in a clinical trial, you are saying that you understand and accept the risks involved. Consent ensures that you take the proper steps to fully understand the clinical trial for which you are volunteering. You can choose to leave the trial at anytime and for any reason — you just have to inform your study doctor.
Myth 9: Sponsors keep results of the studies a secret.
Many results are now posted on public websites, in line with the laws of a given country. The timing or posting of results varies according to the country and the phase of study.