If you or a loved one is considering becoming a research study participant, take time to learn more about clinical research studies and the role of participants.
What is a Clinical Research Study?
A clinical study is a research study designed to answer specific questions about screening and diagnostic tests, vaccines, new therapies or new ways of using known treatments. Clinical studies – also known as medical research or clinical trials – are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical studies are the fastest and safest way to find treatments that work. They also provide patients with access to the latest medical developments.
Ideas for clinical studies usually come from researchers. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning clinical trials.
After receiving approval from the Food and Drug Administration (FDA), clinical trials proceed through four phases of testing:
- Phase I clinical trials: researchers test a new drug or treatment in a small group of people (approximately 20 - 80) for the first time to evaluate its safety, determine a safe dosage range and identify potential side effects.
- Phase II clinical trials: the study drug or treatment is given to a larger group of people (approximately 100 - 300) to see if it’s effective and to further evaluate its safety.
- Phase III clinical trials: the study drug or treatment is given to large groups of people (approximately 1,000 - 3,000 or more) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
- Phase IV clinical trials: after the drug or treatment has been marketed, these studies continue testing the study drug or treatment to collect information about its effect in various populations and any side effects associated with long-term use.
What are the Pros and Cons of Participating in a Clinical Research Study?
It's important to note that there are both potential benefits and drawbacks to participating in a clinical research study. Weigh their significance before agreeing to participate.
Pros of Participation
As a clinical research participant, you’ll receive high-quality care under close medical supervision. You may also:
- Be one of the first participants to experience positive results from a new therapy
- Benefit science and future patients by increasing knowledge about a disease and its potential treatments
Cons of Participation
It’s also possible that new treatments may not be better than standard care, and may, in fact, be worse. You may:
- Experience unknown side effects worse than those experienced with standard treatments
- Be placed in a control group that receives the standard care instead of the study treatment
- Be placed in a control group and receive placebo (a sugar pill), which has no therapeutic benefit
It’s important to note that cancer clinical trial participants will always receive the current gold standard of care. Investigational drugs or placebo pills are added to the standard of care regimen – not as a replacement for standard of care.
What is Informed Consent?
Prior to participating in a clinical research study, you’ll be asked to provide informed consent. The following are some important notes about informed consent.
- Informed consent is a process, not just a form.
- Complete and understandable information must be presented to potential research participants in order for them to voluntarily decide whether or not to take part in a study.
- The informed consent document will explain the purpose of the study, the length of the study, experimental procedures involved in the study, alternative therapies that are available, risks and benefits of the study and the confidentiality of your research record.
- The signed informed consent document provides the basis for consent and can be used by the participant for future reference.
- The informed consent document will be updated when additional information has been learned about the study. Participants will be asked to review and sign the revised informed consent documents.
- While an informed consent document provides the basic information needed, one of the most vital parts of the informed consent process is the opportunity to discuss any questions or concerns with a knowledgeable member of the research team.
- All research protocols and informed consent documents must be approved by an Institutional Review Board or Committee. This group's primary function is to ensure that the possible benefits of the research being studied outweigh the potential risks and that all known risks are stated in the informed consent document.
Talk with your provider or visit our health library to read more about Clinical Trials: Should You Participate? Other recommended resources can be found from the Office of Human Subjects Research (OHSR), which operates within the National Institutes of Health (NIH).