Barbara: "If I join a clinical trial, will I be treated like a guinea pig?" Dr. Theo: "That is an excellent point. The thing we have to bear in mind is that even though drugs in trials are experimental, they have to go through several different steps before being approved. As a starting point, drugs of the future are discovered and tested in animal studies before ever reaching human clinical trials. It's only the most promising drugs that will be tested in humans and those go through extensive testing. As an example: On average, a new cancer drug has been studied for at least 6 years before it even makes it into clinical trials. So by that point, there are likely to have been one or more trials that show that the drug is at least safe. Now, before any clinical trial starts, it must pass ethical standards to ensure that it's safe and that the volunteers will get treatment that is at least as good as (and maybe even better than) what they would get if they didn't volunteer. Finally - and really important - scientific review committees comprising of independent medical experts are set up to approve and review all trials before researchers can sign patients up and every few months after the trial has started. If the risks at any time are considered to outweigh the benefits, the trial will not be allowed to continue."
Barbara: "Is joining a clinical trial expensive? Is it covered by insurance?" Dr. Theo: "Here's where it's really good news. In general, the entire cost of being on a study is paid for by the sponsor, meaning the pharmaceutical or biotech company that's manufacturing the drug. In general, if you ever come across a study where you're expected to pay, it's not a real clinical trial. Now, the one exception to the sponsor paying for all study-related costs is the following: let's assume you're in a clinical trial for Crohn's Disease or Ulcerative Colitis and you have some eye condition that occurs while you're on study. In general, your insurance would have to pay for this non study-related condition."
Barbara: "Why should I join a clinical trial?" Dr. Theo: "This is one of the most common questions I'm asked, Barbara and Cooper. As a patient in a clinical trial, you will get access to research treatments before they're widely available and these new drugs might be safer or even work better than current treatment options. You will also get closer attention from the clinical research team responsible for your care and more careful monitoring of your condition. Another point in consideration is that it could be cheaper than other available treatments since most study sponsors may pay your research related medical care throughout the study. The final benefit is that you can help others by contributing to important medical research. At the same time, there are potential risks associated with clinical trials that you should bear in mind. First, you may experience unpleasant or even life-threatening side effects from experimental treatments. Then, as with any other treatment, it may not be effective for you even if it helps others. Additionally, you may not even know what you're getting if your study is blinded. Finally, participation may be more time consuming than standard care, as you'll likely be making more frequent trips for studies and procedures. In conclusion, as with any medical decision - be sure to factor in all potential benefits and risks before participating in a clinical trial."
Cooper: "If she enrolls in a study, can she back out?" Dr. Theo: "It's really important for you to understand that if you're in a clinical trial, you absolutely have the right to withdraw from being in the trial at any time, for any reason. But if you do decide to withdraw from the study, it would be wise to talk to your doctor beforehand to see if perhaps withdrawing could have a negative impact on your health. In addition, from the standpoint of all the information that's been collected from the clinical trial, the study site may ask you to come back after you have withdrawn for a few additional visits to be sure that the drugs had no negative impact on your wellbeing."
Barbara: "I don't want to do the clinical trial. What if I'm the one who gets the sugar pill?" Cooper: "Yeah, I mean all that time and energy for nothing?" Dr. Theo: "Great question. Even when clinical trials are going to be using placebo, there are ways to design a trial to make sure that patients will get an active treatment - a real treatment - for the condition either right in the beginning or within a few weeks of starting the trial. Let me give you two examples: There are some trials where you will get study drug or placebo, but if the patient's not doing well after say 10 weeks, they're guaranteed of getting study drug automatically. Here is a second possibility very commonly used in cancer trials: All the patients will get established study treatment that's out there - so everybody's getting standard of care - some patients will (in addition) get a boost with study drug while others will get placebo. One other thing we can do to make sure that more patients actually get the boost rather than the placebo: For example, 2/3 of the patients may get the study drug and only 1/3 get the placebo."
Barbara: "Will I get paid to participate in this study?" Dr. Theo: "In general, clinical research study patients receive a small amount of money just to cover expenses for each visit including gas, freeway tolls, and parking. The one key exception to this is volunteer trials (usually very early stage) where patients are going to be coming in and sometimes require prolonged stays, including an overnight in the testing facility. They may get paid a few hundred dollars."
Cooper: "What is a clinical trial?" Dr. Theo: "Clinical trials are studies in which patients volunteer to test new drugs or devices. Doctors will use clinical trials to learn whether a new treatment works and it's safe for people. Now, of course, these trials are needed to develop new treatments for all kinds of diseases all the way from mild through life-threatening."
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