Clinical trials are an important step in the research and development process for new drugs and treatments. Learn more about what they involve with these frequently asked questions:
What is a clinical trial?
The broad definition of a clinical trial is a biomedical or health-related research study involving humans that is governed by a rigorous, pre-defined protocol. When new therapies or procedures have demonstrated significant promise in the laboratory, researchers initiate clinical trials in order to gather more information about how well these experimental treatments work.
Who can participate in a clinical trial?
Depending on the particular treatment or therapy being researched, each clinical trial will have specific guidelines about who is eligible to participate. These are known as inclusion criteria, which are the factors that allow a person to participate in a clinical trial; and exclusion criteria, which are the factors that disallow participation. These criteria are based on a wide range of factors, such as age, gender, previous treatment history, and medical conditions, including the type and stage of the particular illness being studied. The most important thing to understand about inclusion and exclusion criteria is that they are not used to reject people personally; rather, they are an important medical research principle that helps both to produce reliable results and to ensure the safety of participants in the trial.
What is informed consent?
Informed consent refers to the process of learning and understanding the central facts about a clinical trial before agreeing to participate. Physicians and nurses involved in the trial will explain the details of the study to participants, and participants will also receive an informed consent document that outlines the study’s main points, including its purpose, duration, necessary procedures, and key contacts. The risks and benefits of the trial are also explained in this document. Participants can and should ask questions to ensure they fully understand the study and the implications of participating in it. Patients can then decide if they wish to sign the document and participate in the trial. It is important to note that a signed informed consent document does not constitute a contract. Participants may withdraw from a clinical trial at any time.
What is a protocol?
This is the term for the study plan that all clinical trials are based on; it has been carefully designed to ensure that specific research questions are answered and that participant health and safety are maintained. A protocol outlines who may participate in the trial; describes the specific schedule of procedures, tests, medications, and dosages; and establishes the length of the study. Clinical trial patients following a protocol have regular visits with research staff to monitor their health and the safety and effectiveness of the treatment.
How is participant safety protected?
Clinical trials are subject to the same ethical and legal codes that govern medical practice. They are also additionally regulated by built-in safeguards, such as the protocol, to protect participants. As a clinical trial progresses, results are reported to medical journals, at scientific meetings, and to various government agencies. Individual participants’ names are kept confidential and not mentioned in these reports.
What are the risks and benefits of clinical trial participation?
Because clinical trials are experimental procedures, they are naturally not without risks, which participants must be sure to fully understand before agreeing to join the study. The side effects of the experimental treatment may be unpleasant, serious, or even life-threatening; the treatment may not prove effective for the participant; and the protocol may require a greater amount of time and attention than a non-protocol treatment—for example, in the form of hospital stays, trips to the study site, more treatments, or complex dosage requirements.
However, clinical trials can also offer many benefits to eligible participants. These include the opportunity to play a more active role in their own health care process; access to new treatments that are not yet widely available; expert care from leading medical facilities and practitioners during the trial; and the chance to help others by furthering medical research.
What should potential clinical trial participants consider?
It is very important that potential participants in a clinical trial know as much as possible about the study and that they feel comfortable discussing their questions with the research team. Common questions and issues that participants should consider include who will be in charge of participants’ care during the trial; why researchers believe the experimental treatment will be effective and whether it has been tested before; what kinds of tests and treatments participants will be subject to and how their risks, side effects, and benefits compare to any current treatment; who will pay for the experimental treatment and whether reimbursement is available for other expenses; and whether the study offers long-term follow-up care. Some of these questions will be addressed in the informed consent document.