What’s it like? Are they using me as a guinea pig? Will I get a placebo? Are the trials biased by pharmaceutial companies who sponsor them? Are all trials sponsored by pharma? Is it an experiment? Can I drop out of the trial if I choose? Is it scary?
Those are all valid questions I’ve heard over and over again before, during and after I was a patient in a clinical trial. My husband was asked those very same questions by those who were either too embarrassed to ask me or assumed I was too fragile to answer.
I participated in a clinical trial at The National Cancer Institute – part of The National Institutes of Health in Bethesda, Maryland – a group of 27 different centers and institutes whose focus is research. There are, in addition, many other trials groups and academic centers who offer clinical trials as well, possibly not too far from where you live. Medications, tests and exams are free. Some, but not all trials, pay for travel expenses too. That’s where foundations can help. Check out my previous blog: https://reinaweiner.com/2015/09/02/finding-money-for-expensive-drugs/
What was it like to be a patient there? From the moment I signed the consent form and joined the trial I knew I was in very good hands. Doctors and nurses who engage in and manage clinical trials sites are on the cutting edge of medicine. Their expertise and dedication to research in the search for cures and improved quality of life for patients places them and the patients they serve in a unparalleled level of medicine. The extensive time and effort required to collect data isn’t a whole lot of fun for them, but it’s a requirement that creates a reliable, well-balanced, scientific study which translates into new and innovative treatments that show up in our local doctor’s offices around the country. The doctors quietly listening to any and all side effects I experienced, talking with me at length while keeping extremely detailed and accurate records of my care as required in every clinical trial. Nurses were always professional, patient, caring and friendly. Everyone else I came in contact with – pharmacists, phlebotomists, EKG techs, receptionists – were the same. After receiving 48 treatments my impression of The NIH clinical trial remained the same: I was in very good hands.
What’s important about clinical trials? You probably know that all medications – prescriptions or over-the-counter drugs approved by The FDA – must go through the clinical trials process to ensure their proper dosage, safety and efficacy. Therefore, if no one volunteers for a trial, no new drugs become available. Unfortunately, only about 3% of all cancer patients – out of about 3 million –participate in clinical trials. Of course, there are ongoing trials for many other illnesses as well not just cancer. The bottom line is this: No volunteers = no trials = no medical advances. At the moment a new treatment for a serious illness may not be on your radar screen, but in the future, it could be for you or someone you care about.
A few thoughts to bear in mind:
You are NOT A GUINEA PIG. All trials go through a rigorous approval process medically and legally before they are offered to the public. The new drug I was on had already been administered to 500 people. Not all trials have been administered to so many people prior to your acceptance in a trial, but all approved trials are meticulously designed to be as safe as possible while still advancing medical research.
Pharmaceutical Companies provide financing for the trials, but are prohibited from biasing the participants or the results. Bias in a trial would render the data unreliable and therefore, useless.
PLACEBOS are very rarely used in a trial. If they are, they would most often be used in combination with another medication. Trials are designed to ensure a patient’s health is never in jeopardy.
If there are several “arms”(groups) on the trial comparing one treatment to another, patients are always switched to the treatment exhibiting the best results.
Yes, all trials are essentially research experiments, but they are very, very carefully designed and monitored to search for new and better treatments. As mentioned above, a patient’s safety is always a major consideration of trial design.
Was I scared? You bet. Cancer itself is pretty darn scary no matter where you go for treatment. For me personally, my goal was to receive the best treatment available. But, even more importantly, when you enroll in a clinical trial you have the opportunity to be part of the big picture, that is, you can be part of a potential cure. Your participation may result in a significant contribution to the health of all the patients who will follow you. Really, what could be more important?
Can I drop out of the trial? Yes, you can. In order to participate in the trial it’s necessary for you to sign an informed consent agreement. After signing, you can drop out of the trial at any time or for any reason whatsoever. There is no pressure to remain in the trial if you no longer want to be in it. Of course, if your illness progresses while on the trial, your physician will remove you from the trial and guide you to another form of treatment.
How do you find out about a clinical trial? ASK YOUR DOCTOR IF THERE’S A TRIAL YOU MIGHT BE ELIGIBLE FOR BEFORE YOU BEGIN TREATMENT WITH HER. Either she or a nurse will need to do a search. *At http://www.SearchClinicalTrials.org they will do a free search for you and educate you about the clinical trials experience. You can go to http://www.cancer.gov (for cancer patients), or you can google organizations who provide education for your particular health problem who will then direct you to potential clinical trials. Lots of research and patience is key. This is difficult to do on your own when you’re the patient. You’ve got enough on your mind. Ask family, friends, etc. who are internet savvy to help you.
Want to learn more about clinical trials? A new website -*www.LearnAboutClinicalTrials.org – is a great place to begin. Patients and professionals discuss their experiences through videos. There’s plenty to read about as well.
And lastly, Would I do it again? Definitely. Right now I’m enrolling in another trial that may answer more questions for patients who have the same health challenges as I do. Nothing to lose and everything to gain.