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If your doctor has suggested you participate in a clinical trial, it's easy to begin calling to mind images of doctors in lab coats poking and prodding you, treating you as little more than a scientific experiment. Clinical trials aren't nearly as mysterious or frightening as they sound, and the right clinical trial could even give you access to a cure long before it becomes available to the general public. If you're debating participating in a clinical trial, here's what you need to know.
What is a Clinical Trial?
Clinical trials stand at the cutting edge of medical research. These trials allow doctors to study new medications, look at potential new uses for old ones, and test out new theories about how diseases affect the body.
In most cases, researchers seek out a specific type of patient. You may need to meet certain demographic criteria, have a specific medical condition, or have not had good luck with standard medical protocols. This means it's important to be honest if you want to get the most out of a clinical trial.
Because clinical trials are experiments, they don't always work. There is a possibility that the drug you try will do nothing, or cause unwanted side effects. For this reason, most clinical trials come with long forms called "Informed Consent". It's critically important that you read these forms in their entirety to determine whether you're comfortable taking the risks they outline.
Will a Clinical Trial Cure Me?
Clinical trials are experiments, so there's no way to predict whether or not the trial will be effective. It's important, though, to ask about the nature of the study in which you're participating. Some clinical trials are merely data-gathering ventures, where researchers collect data about your life history and the progression of the disease. Others are more traditional experiments, where one half of a group receives the treatment and the other half receives a placebo (if the treatment works, the placebo group often later gets a chance to take the drug, too). Still others measure whether medications can improve quality of life, even when they don't offer a cure.
Though clinical trials offer cutting-edge research and plenty of hope, the hard reality is that most clinical trials don't work. This isn't a reason not to participate, though. If a clinical trial fails, you won't necessarily be harmed. You'll merely have to find another treatment option, or consider participating in a new clinical trial. It's important also to ask if you'll be allowed to continue with your current treatment regimen. Many clinical trials require you to cease other treatments to get the clearest scientific results, though others allow you to blend the clinical trial with other treatment plans.
Are Clinical Trials Safe?
When you join a clinical trial, you're trying out medications that have already been tested in many ways. Frequently the drugs have proven safe in animals, but even when animal testing has not occurred, scientific modeling, research on human cells, basic knowledge about the drugs' ingredients, and similar safety measures minimize the risk of a serious complication.
Some people do experience side effects, but these effects are minimal, and typically disappear as soon as you begin taking the drug. Common side effects include nausea, vomiting, rashes, changes in mood or behavior, sleeping problems, and weight loss or gain. Rarely, participants can suffer more serious side effects, such as psychosis, seizures, coma, and even death. No clinical trial can be 100 percent safe, but by carefully monitoring your symptoms and immediately reporting any side effects to your doctor, you can almost completely reduce your risk of experiencing life-threatening side effects.
Questions to Ask Before Undertaking a Clinical Trial
Because clinical trials are experiments, it's not always possible for your doctor to answer all of your questions. In double-blind placebo studies, for instance, your doctor will not be able to tell you whether you will receive medication or a placebo. If your doctor is unable to answer your question, feel free to ask why.
Some of the most important questions to ask before signing up for a clinical trial include:
- What is the purpose of this study? What is being tested?
- What is the best-case scenario for this study?
- What are the potential risks? What's the worst-case scenario?
- How long will the trial last?
- What are the most likely side effects?
- To whom should I report any side effects I experience?
- What activities should I cease during the trial? Are there any drugs or medications I should stop taking?
- Can I continue with my usual medical regimen while participating in this trial?
- When will I learn about the trial's results?
- If I am given a placebo, will I have the option to take the real medication when the study ends?
- To whom can I talk if I have any questions about the study?
- How do the risks and benefits of this treatment compare to the standard treatment?
- Will I have to cover any costs? What about if I suffer side effects? Will those costs be covered?
- What will be my responsibilities as a part of this trial? How often will I have to meet with a medical provider?
- Are there any better, established treatments than the one I'm currently using?
A clinical trial is a gamble, but the risks are usually small due to stringest regulations. The potential payout, however, could be huge, since it is only through clinical trials that miraculous cures and life-altering medications can be discovered. The Rochester Center for Behavioral Medicine encourages each of our patients to explore all of their treatment options, and we firmly believe that clinical trials can prove invaluable in the ongoing fight against innumerable diseases.
References:
Questions to ask your doctor about clinical trials. (2012, November 2). Retrieved from http://www.cancer.gov/clinicaltrials/learningabout/questions-to-ask
The Basics - NIH clinical research trials. (n.d.). Retrieved from http://www.nih.gov/health/clinicaltrials/basics.htm
