PATIENT INFORMATION BRIEF
COMMON MYTHS ABOUT CLINICAL TRIALS
Clinical trials are unsafe
Participation in a clinical trial is not without risk. In fact, all clinical trials have both risks and benefits. The risks of participation is dependent upon the nature and scope of the treatment being studied and the health status of the participating subjects. Full disclosure of the risks and benefits of participation in a given clinical trial is to be provided to potential participants during the informed consent process. Your decision to participate is exactly that – YOUR DECISION. If you have questions or concerns, be sure to ask during the consent process. Moreover, if new risk information becomes available during a trial, the researchers are mandated to inform you of the newly discovered risks. (Refer to the Information Brief entitled Questions and Answers for Patient Considering Participation in a Clinical Trial in this section of the website).
Being in a clinical trial won’t help me.
It is important that before you elect to participate in a clinical trial you talk to your doctor and/or a member of the clinical trial research team to gain some insight as to how the trial and the new treatment being investigated may help you. If you elect to participate, the clinical trial research team will monitor you very closely, perhaps even more closely than your own doctor or nurse during your regular office visits. As part of this vigilent monitoring process, you may get additional tests and lab work that might not be part of your usual care.
Researchers treat people who participant in clinical trials like guinea pigs
For all clinical trials, extensive effort is placed on ensuring the safety and well-being of participants, protecting their legal rights, and addressing their ethical concerns.
Some of my friends have told me that some people who try to volunteer for a clinical trial are told by their doctor and/or a member of the clinical trial research team that they are not allowed to be in the trial.
All clinical trials include strict “inclusion criteria” and “exclusion criteria” criteria for participation. Inclusion criteria are factors that allow you to take part in a clinical trial (for example type of disease or condition you are experiencing and your current treatment). Factors that exclude or prevent participation are “exclusion criteria.” These criteria are based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions you may have. In general, inclusion and exclusion criteria for a given clinical trial are strict. Strict adherence to inclusion and exclusion criteria allows researchers to gain confidence that whatever findings are derived from a given trial are not the result of random uncontrolled factors.
If I am offered a clinical trial I have no other options for care.
In some cases, you may be offered a clinical trial when there are no further standard-or-care treatment options available. That said, it is more likely that there are clinical trials available even when there are standard treatment options also available. Clinical trials often involve standard treatment options plus an addition new mediation. Again, the decision to participate in a trial is a very personal one and you should always discuss with your doctor and/or a member of the clinical trial team your issues and concerns.
If I elect not to participate in a clinical trial my doctor and my clinical team will start treating me differently.
The decision to participate or not participate in a clinical trial is YOUR DECISION. In all cases, your decision is honored and will not impact the dedicated care and treated you receive from your doctor or doctors and their respective clinical staff.
Once you sign the informed consent form, you’re legally bound to participate
Study participants can decide not to participate or leave a study at any time. Signing the informed consent form does not bind them to participate. Study volunteers work closely with their doctors in order to determine the best possible approach for treating their condition.
It costs a lot to participate in a clinical trial
In most clinical trials the sponsor of trial (the company that is developing the investigational medicine) assume all costs of the study medications, study related medical procedures, and medical care received related to the study while a participant is enrolled in a study. Moreover, participants in many clinical trials are reimbursed for expenses incurred due to participation in a study, such as travel and parking costs. Also, many health insurance carriers cover patient care costs for investigational interventions. It is important that you ask the clinical trial research team which costs will be your responsibility and also check with your health insurance carrier about the coverage they provide for clinical trial participants before making the decision about participating in a clinical trial.
If you participate in a clinical trial you may get a “sugar pill” or placebo instead of a real drug.
A placebo is a product that looks exactly like the medication under study but does not cause harm or good. Importantly, the decision about whether to use a placebo in a clinical trial is based on how serious the illness is, whether an existing treatment is available and other considerations that ensure a high standard of ethics. If you have a serious or life-threatening disease, the best available treatment (called “standard of care”) will be used instead of a placebo, not a “sugar pill”.
NOTE: Some of the information used to develop this information Brief was modified from a piece prepared by the Center for Information & Study on Clinical Research Participation, an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.