I'm hoping to inspire others to tell their clinical trial stories, so here is one of mine:

Why did you volunteer? Was either access to treatment in the randomized study, or access to treatment in extended open label studies important to your choice? How did the access to new treatment incentive compare to the value of science in your decision? Or to what you would learn from the participation?

I volunteered for several reasons:
1. this was a new treatment that could be neuroprotective. Pre-clinical trials on rats & monkeys showed that it slowed or toopped the progression of pd.
2. It was placebo controlled - while I desperately wanted to get the drug, I knew that even if I got the placebo, my participation would help all people with parkinson's … in the end
3. if the drug were neuroprotective, I had a 75% chance of getting it and bettering my condition.

Did you get placebo? When unblinded, what did you think you got before unblinded? Did you experience change in symptoms, how long did changes last?

I got the lowest dose of 3 doses of the drug: high, medium, low, and placebo.

My symptoms from the experimental drug were extreme fatigue, and occasional nausea. When not on the drug, the symptoms ended.

What was primary outcome? What was your change in baseline to follow up? How long were you tracked, did clinical improvements continue to increase, decrease or stay the same?

My pd symptoms continued to increase. I was tracked for 20 months. When I started, I was not on PD meds. I started on agonists during the trial. The symptom most troubling to me, which precipitated my starting agonists, was neuropathic pain. But my other pd symptoms progressed as well: stiffness, bradykinesia, tremor, balance

Were there other key measures. Were imaging or other markers used?. How did they change over time? Were you satisfied with the feedback and reporting to you of findings from your data, and with privacy of data?

SPECT scans were taken twice - once at the beginning and once after approx 20 months. The scans did confirm that I had pd. And they did show that the disease had progressed. I received copies of my scans, although they refused to give me a clinical diagnosis of my scans.

I also went through many many physical tests. At first, I was tested to make sure I was healthy enough for the trial (EKG, blood, fecal, mental). After being in the trial, I was regularly tested. Tests included: blood tests, EKG, fecal, UPDRS, mental, blood pressure, SPECT imaging,

Did the informed consent (IC) cover how you would be treated if the study was terminated early? Did the IC explain the risks? What were they? With respect to unknown effects of treatment? with respect to surgery? Was the placebo effect explained to you? And were you given any strategies to minimize placebo effects?

The study was stopped early - abruptly - with no warning. Patients learned this because the company posted the trial halt on their website one evening. Patients heard nothing for weeks. We did not know if we should continue on the study drug or if we should stop it. I was on schedule to travel 2000 miles for my second SPECT imaging scan, and no one knew if I should proceed or not (this included the study center doing the SPECT scans).

Early trial halt procedures were NOT covered in the IC.
The IC explained possible risks. The IC did not explain possible placebo effects.

Did the sponsors of the study explain how you would benefit if the trial proved successful and how you may be harmed if there were problems with your treatment or with the overall study (for surgery was it explained that acceptance of this treatment would likely make you ineligible for future experimental trials?)

I specifically asked if I would receive the study drug - if it were successsful - after the trial ended. The study nurse and trial doctor said it wasn't covered in the IC agreement, but they would make my sentiments known. My concern was if the drug were successful, and If I had been on the placebo or not on an optimum dose, after the trial ended I wanted to be given the dose that worked. I told them it was only fair because of my comitment and participation in the trial.

I received no promises or response of any kind. As it turned out - the trial failed. And the people on the drug actually saw their pd symptoms progress faster than the people who were on the placebo.

One of the unanswered questions for me is this: the initial people in the trial were allowed to take coq10 1200mg per day. By the time I started in the trial, participants were limited to taking less than 600mg of coq10 per day. What percentage of people on the placebo were also taking 1200mg of coq10 per day? Is that why people on the placebo did better than people on the trial drug?

I have asked but not gotten a reply.

Would you be less interested in a study sponsored by a company with significant ethical violations (conflicts of interests)? Failure to disclose data to advance science or to monitor safety in community settings, failure to live up to agreements with patients about conditions in the study or with ongoing clinical tests.

I absolutely would be less interested to take part in a study sponsored by a company with significant ethical violations - Specifically I would be very careful before I agreed to participate in an Amgen study. I believe the way Amgen treated its GDNF trial participants was shameful. They could have provided their participants compassionate use of GDNF, but AMGEN has steadfastly refused to do so.