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My Clinical Trial Experience
I had never even heard the words "clinical trial" prior to my interest in participating in one myself. Then one day I was faced with making one of the most important decisions in my life: did I want to be - should I want to be - a part of a clinical trial for Parkinson's disease?
When I was first diagnosed by a local neurologist in 1994, I immediately asked for a referral for a second opinion to a larger research facility where I would see a Movement Disorder Specialist (MDS). After a consultation with my neurologist, I chose Emory University in Atlanta, GA. It was a six-hour drive from my home, but the peace of mind that I was seeking - that I could be sure of my diagnosis one way or the other - was of great importance to me.
The original diagnosis was unfortunately confirmed by my new doctor, a pleasant young woman who was obviously well informed. She suggested an annual follow-up visit, with my local neurologist taking care of my daily needs between visits to Atlanta. The plan worked well, and every year I was informed of new and developing therapies at Emory and other research facilities.
In 1998, my career as an elementary school principal came to an abrupt end. I had been trying to keep the pace of a busy administrator's job and to "pretend" that I wasn't really sick. However, my symptoms had worsened to the point that getting to school at all, much less on time, was a nearly impossible undertaking. With the balance of my available sick leave rapidly dwindling, an honest face-to-face encounter with my mirror told me that I couldn't keep up this pace. I applied for disability retirement after a period of hospitalization for which the admitting diagnosis had been bleakly labeled a "Parkinson's Crisis."
In 1999, on one of my annual trips to Emory, I asked if there were any promising new treatments. The doctor mentioned a "new" study involving a surgical implant in the brain that was something like a heart pacemaker. I made my decision right then to be added to a waiting list of potential volunteers.
In April of 2000, I received a call from a research nurse at Emory. I thought she was calling about the waiting list, but she explained that she was contacting me about another new study. They were looking for just six people in a new surgical procedure that had never been tested be-fore in humans. The research nurse talked with me for over an hour and answered my questions. She reviewed for me the test results up to this point -including the successful testing of the product in monkeys - and identified the "inclusion and exclusion criteria" (that is, the standards that determine if a person can join a study). I was definitely interested. She said she would mail me an "informed consent" form - a document that explains the results thus far, the qualifying criteria, the detailed procedure and the risks involved.
When I received the document, I was amazed by the detail! Even the risk of infection possibilities from routine blood sampling was included. I scrutinized the document and did some research on my own via the Internet. My husband and I had discussed how far we were willing to go, cost-wise, to have a better quality of life. When I read that all costs incurred would be covered by the sponsor, I was convinced that I should be a part of this study. The inclusion criteria fit, and I called to set up a screening appointment.
At the screening appointment, I had to be thoroughly tested, including blood work, EKG and MRI. The tests had to be done twice: once when I had been free of all medications for 12 hours and another time after taking all the medications. The information from these tests would come to be known as my "baseline" statistics. I would be measured not against the other people in my group of six, but only against myself. I crossed my fingers that I would qualify.
Following testing by the research nurse, I was introduced to the investigating physician, a doctor whose name was familiar from my Internet research. Following an examination by this doctor, I heard him discussing "dates" with the research nurse. I interrupted their conversation, "What are we talking about? What are you trying to schedule?" When they replied, "Your surgery!" I squealed for joy, and the next thing I knew I was hugging the nurse! I had qualified - I was in the study!
After a visit to the neurosurgeon to get his "thumbs-up," the rest was a whirlwind. The surgery was done in August 2000, and it went well. For the first several weeks after the surgery, I was followed weekly; then monthly; then quarterly; and finally, once a year. It has now been four years into the study, and I have been kept well informed of the developments.
Readers who may be considering participating in a trial should first think of this: PD is a progressive neurological disorder. Unless a cure is found or significant strides are made in treatment, we will all find our capacities greatly diminished over time. Sure, joining a trial requires some elements of risk, but it could bring us - all of us - closer to a cure. The alternative - that is, if none of us were to join a trial - is that Parkinson's is destined to remain a progressive disease with an unknown cause. And it waits for no one.
Besides which, there are distinct advantages to the PWP in participating in a clinical trial. You will receive care and assessment from some of the finest Parkinson's specialists. You will have a better understanding of yourself and your disease. And you will come to understand the U.S. Food and Drug Administration (FDA) approval process and the politics involved. I went into my clinical trial with this attitude: If it did nothing more than slow the progression of my disease, it would have been worth the effort. Even if the study were to "fail," if it helped pave the way for an alternative approach, it would have been a success. Why was I willing to participate in a surgical trial for which no one could know, in advance, the chances of success in human subjects? The answer was simple: it is our hope.
We, the people who live with Parkinson's, may hold the keys to this hope - this hope for a better quality of life, the hope for making life better for future generations. In short, and for certain: we can be a part of the "CURE."