Trial Terms Defined
Your informed consent is required before being enrolled in a trial. This means you have been provided all relevant information about the study design, how you will participate, your right to withdraw at any time, study alternatives, your personal data protection and the associated risks and benefits. Informed consent is designed to protect patient safety and privacy.
“Standard of care” is an intervention already approved for a specific health condition that is available publicly. Interventions in a clinical trial are still being tested to ensure safety and effectiveness.
To ensure quality data and no bias when comparisons need to be made between treatment groups, each participant is randomly assigned to the different groups (i.e., experimental intervention, standard intervention, or placebo). Think about a coin toss: Just as it is unknown whether you will turn up heads or tails, it is unknown whether you will receive an intervention or a placebo.
A placebo is an inactive version of an intervention that is not intended to provide any medical benefit. It is designed to look the same as the active intervention, so the participant and research team do not know it is a placebo. The placebo is used by comparison to confirm any effects of the intervention being studied, if no approved intervention is available.
Some clinical trials are designed to be “double blind” so both participants and researchers are unaware of which treatment group participants are assigned to. This prevents bias from affecting clinical trial data.
Researchers must compare the effects of a new intervention on participants to those who do not receive the intervention. They are called the “control” or “control group,” and they may receive either a placebo or nothing at all.
Under FDA regulations, an Institutional Review Board (IRB) is a group that has been formally designated to review and monitor research at a hospital or institution involving human participants. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in, or disapprove research.
Under European Medicines Agency (EMA) regulations, an Ethics Committee (EC) reviews research proposals at a healthcare facility involving human participants and their data to ensure that they agree with local and international ethical guidelines. ECs have the authority to approve, reject, modify or stop studies that do not conform to the accepted standards.
A DSMB is a group of qualified individuals that monitors the clinical study to ensure the safety of study participants, as well as the validity and integrity of the study data.
Patients with an immediately life-threatening condition can potentially gain access to an experimental intervention when there are no other adequate options available. This type of clinical trial is different from the normal types of trials because it offers people access to a study drug even if they can’t participate in a clinical trial.