University research hospitals and some health-oriented private companies rely on clinical research to gain critical knowledge about specific treatments or behaviors, which in turn, can make the biggest positive impact in many people’s lives.
Before any new experimental treatment can gain approval from the Food and Drug Administration and be put on the open market for distribution at your local pharmacy, it must be shown to achieve its intended goal in many people, and its risks or side effects must be well documented.
This would not be possible without first testing the treatment in humans. This test is known as a clinical study.
While not all clinical studies involve testing new treatments, these types of studies may appeal to people with life-threatening diseases or conditions where there are few options for improving their quality of life or prolonging their life.
Many people have found renewed hope through clinical studies, but they aren’t for everyone. So how do you know which study is right for you?
Before beginning any clinical study, it is important for you to know as much as possible about the clinical trial and feel comfortable asking the health care team questions about it.
Some important questions for you to ask will be discussed later. For now, let's talk about the clinical trial process.
People who qualify for any clinical trial should always be told up front what to expect from their participation before choosing whether or not to voluntarily enroll. This process is called “informed consent”.
Informed consent should not end there. It is a continuing process throughout the study to provide you the information you need.
During the initial Inform consent process, doctors and nurses involved in the trial explain the details of the study to help someone decide whether or not to participate. If the participant's native language is not English, translation assistance can be provided.
Once a prospective participant understands the study details, a research team member provides you with an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts.
Risks and potential benefits should always be explained in the informed consent document. The participant then decides whether or not to sign the document.
Be aware that informed consent is not a contract, and you may withdraw from any trial at any time, for any reason.
During the informed consent process, you should ask any questions you have about the study and be satisfied with the answers before entering the study. Many questions you may have are likely to be answered during your initial meeting with study coordinator but if they aren’t, you should feel comfortable enough with the study’s health care team to ask additional questions.
Before your meeting with the study coordinator, plan ahead and write down any questions you want to ask. Bring a friend to your meeting as support and to hear the responses to the questions. They may pick up on something you missed.
Or you may want to bring a tape recorder to replay the discussion later. As the participant, look for well-planned and well-executed clinical trials.
Stony Brook University Cancer Center suggests prospective participants ask these important questions before entering any clinical trial:
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me? Will my primary care physician be informed?
- Who will be in charge of my care?
If you still aren’t sure if the clinical study is right for you, discuss the trial with your primary health care team. They can advise you on the risks and benefits of participating, and if you are still not comfortable, they may be able to offer alternative studies for you to investigate.
Lynette Summerill is an award-winning writer and Scuba enthusiast living in San Diego, CA with her husband and two beach loving dogs. In addition to writing about cancer-related issues for EmpowHER, her work has been seen in newspapers and magazines around the world.
Stony Brook University Cancer Center online: http://www.stonybrookmedicalcenter.org/cancer_center/cancer_clinical_trials/faqs
National Cancer Institute. A Guide to Understanding Informed Consent. Accessed online 6 March 6, 2012 at: http://www.cancer.gov/clinicaltrials/patientsafety/informed-consent-guide/page2
Reviewed March 13, 2012
by Michele Blacksberg RN
Edited by Jody Smith