02 Aug Why a Clinical Trial May Matter to You
If you or a loved one have started considering treatment options, or if you are considering making some changes to your treatment, you may want to know more about participating in a clinical trial.
What is a clinical trial?
A clinical trial is a research study that “prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Practically speaking, clinical trials are research studies that find and test new treatments or procedures (interventions). Without clinical trials, we would not have the medical and scientific advances that we have today.
The most important first step is to understand your diagnosis. Make sure you discuss with your doctor and other members of your health care team the type of cancer you have, the stage of the cancer, and what all your possible treatment options might be.
There are a few things you should know about clinical trials. First, you should know that a clinical trial is an investigational treatment or procedure. This can mean that you may be receiving something not approved by the FDA or is not approved for the specific treatment you are receiving. This does not mean that a clinical trial is a “last resort,” many clinical trials are already in place because research indicates they are likely better than the standard of care. Clinical trials aim to improve the current standard of care, and as a participant, you will receive at least the current standard of care for your diagnosis. For some patients, this means you will get an excellent level of care because they are being carefully monitored and evaluated. But what if I get the “placebo?” When we are talking about cancer care, you will not be receiving “no treatment.” You will receive the current standard of care, which means that you will receive at a minimum what other patients facing the same diagnosis will receive.
Have a conversation with your healthcare providers. If you are interested in learning what clinical trials may be available to you, ask your doctor or other members of your health care team if they offer any trials or if you are eligible as a candidate for any current clinical trials. If you are really interested in getting involved in a clinical trial and your doctor does not have any available, it may be beneficial for you to seek a second opinion or check many of the online resources that list current clinical trials. Http://www.Cancer.gov and htty://www.clincialtrials.gov are great resources for available clinical trials, in addition to valuable information regarding the clinical trial process.
The low down on the safety of clinical trials. There are a lot of safeguards in place for patients who participate in clinical trials. Clinical trials are designed to minimize potential risk and have to abide by a strict set of guidelines. Each trial has a treatment protocol that must be followed. This protocol is reviewed by the Institutional Review Board, or IRB, to ensure patient safety. Throughout the trial, data is reviewed to see how patients are responding to treatments, and it is determined whether or not the trial should continue.
You should also know about informed consent. Informed consent is contained in a document that you sign, which protects you as a patient. You cannot receive treatment until you have signed this legal document. In order for you to give your “informed consent” to participate in the trial, you must receive all of the information about the trial and who you can contact with questions or if you experience side effects. It also contains all of the information regarding the process, whether you will have to take any extra steps or tests during treatment, what the known risks or benefits may be, and detailed information on patient rights. When you sign this document, you are not giving up your rights. You are still able to drop out of the trial at any time and leave without penalty. As with any legal document, it is important to sign it only if you understand what it contains. If you don’t understand any part of it, be sure to ask questions.
Weighing the pros. The best possible outcome of a clinical trial is that the treatment has a positive outcome, and improves upon the current standard treatments. This may mean that patients see a better quality of life with the treatment, or that patients have a positive reaction to an investigational drug or treatment. Participating in a clinical trial gives you the ability to be an active participant in your treatment process by understanding and evaluating your diagnosis. There is a certain level of altruism involved in knowing that you may be helping other people, and are contributing to the advancement of science and research through participation.
Weighing the cons. There may be additional costs to becoming a part of a clinical trial. You may face outside expenses, such as travel, childcare, and your insurance coverage may not cover extra testing that you may need in the trial. From a more practical standpoint, there may be extra time involved that may take away from time spent at work or with your family. You may also experience negative side effects from the treatment, making it more difficult to continue working or affect your quality of life while undergoing treatment. Finally, there is no guarantee that the trial you are enrolled in will be any more effective than the current standard of care.
Taking careful consideration and weighing the benefits and risks is a necessary step in making a decision to participate in a clinical trial. And remember that even if you chose to participate in a clinical trial, you are not obligated to continue if a treatment becomes too difficult or you no longer want to participate.
Regardless of your participation in a clinical trial it is important to know where to turn for information and support. Be sure that you are engaged and educated regarding your care plan and ask as many questions as you can about your treatment. It is always helpful to have family member a friend as a caregiver, who is able to help you along the way. Having someone else join you at your appointments can serve as a valuable “extra set of ears” and they may ask additional questions.
For more information on clinical trials and to hear what patients and experts have to say, visit Triage Cancer's resource page on clinical trials.
Triage Cancer is also hosting a Clinical Trials 101 Webinar on August 31, 2016, presented by Dr. Susan Love and Monica Bryant, Esq. This webinar will provide tips on how to find clinical trials, dispel common myths, and explain insurance coverage for clinical trials. Register.
Stay tuned for part 2 in this series
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