It's Personal to Us: Robrecht
Robrecht, director, global quality and compliance, is based in our Brussels office.
Years ago, my wife, Ann, suffered from blurred vision. This symptom would come and go without causing impairment. But a few years later, a pins-and-needles sensation appeared in her legs. At that time, our family doctor referred my wife to a neurologist.
The end of 1999 was awful. My wife's spinal tap and MRI confirmed the official diagnosis of multiple sclerosis. At the time of the diagnosis, our world collapsed. Ann started taking interferon injections, which caused side effects. She was working as a mathematics teacher and during her relapses, which could last a few weeks, she would be unable to work. My job required me to travel a lot. Our youngest and fourth child was 16 months old and our others were almost six, four and three. Although my wife was not suffering from a severe form of MS, she often would have a relapse while I was traveling on business.
So, I changed jobs to decrease my travel in order to be more available to my wife and children. Later, I was fortunate to find a position in PPD's Brussels office where I could utilize my 12 years of clinical research experience. It was soon after I joined the company that I learned PPD was managing a trial for an oral medication for MS.
After receiving more information, Ann and I went to the neurologist involved in the study. My wife met the criteria for another trial with the same oral medication and started the trial, not monitored by PPD, in the middle of 2007.
During the informed consent process, it was clear the neurologist was very dedicated to clinical research. As the principal investigator with a busy practice, he still took time to explain the medication and the trial well. He gave us time to think everything over. My wife enrolled and started participating. I saw the comprehensive, multipage documents that she brought home each time an update was released. As both a patient's family member and a PPD employee, it was good to experience this process.
Once on trial medication, Ann's relapses decreased in frequency and impact. They are currently not noticeable, although occasionally she is fatigued. Since she's been on the trial, she has increased the number of hours she works, taking on hours that she had given up because of the effects of MS and her previous treatment. She is getting more involved with her work and our quality of life has improved.
Because of the nature of clinical trials, not every patient can be guaranteed an immediate or direct benefit when participating in a clinical trial. As a scientist, I understand the importance of placebo-controlled testing. Of course, all patients would prefer receiving the best available treatment. Weighing the risks and benefits, it comes down to a very personal decision about whether or not to participate.
Availability of the medication after the trial is another important consideration. When the Declaration of Helsinki made this a requirement, I did not realize how important this would be. My wife is still on expanded access, and is doing great. The expanded access has ensured her being on treatment after the double-blind phase and into the open-label phase. This has resulted in an improved quality of life. We are grateful she did not have to return to the approved medication that was not effective and caused our family stress. For us, participating in a clinical trial was a risk with powerful benefits.
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