Not supporting either side the fence...just the facts...although this may be considered simplistic thinking.

In the CERE-120 trail, I live 2-1/2 hours from the trial site. Ceregene is to pay all my travel expenses and room/board expenses. There is no compensation.

So, is the problem with trial participation how much money is the pharmaceutical company willing to pay, or whether harm will befall me if I participate??

If both, then medical science should be halted altogether. Well, that is if human beings are going to have to participate to allow new therapies or modes of testing to continue to evolve.

Also, when a new therapy becomes available are not the recipients...you and me...in a sort of clinical trial for the first 10 years or more. After all, the therapy has no long term study notes to reveal what the long term effect will be. So, I shouldn't take the new therapy until it has been scripted for at least ten years?

Carolyn
you are exactly right about the first 10 years of therapy being a "trial" period. Think about Sinemet (carbidopa/levadopa) - it took 10 years to realize that the dyskinesias and on/off phenomena were a result of using the medication. BUT I still say that in my opinion they are better than no movement at all!

Sinemet is a miracle! I can be a blob - unable to move my arms or legs, having difficulty talkiing, swallowing and turning my head, be bent over like a 90 year old - and take a Sinemet . . . 30 min. + later, I am totally "normal." If somethingn today were to work like that, we would be endorsing it all over the place! Very few times do people look at what it causes "down the road," unless it's lethal (heart problems, cancer, etc.) Then and only then do we take real note.

Jean - it was wise of you to ask about transportation. This is where the patient input could have helped this trial. Sponsors should build providing transportation into their trial budget, along with providing travel for a campanion. Recruitment and retaining recruits will be faster and will stay with the program longer. Most always these guys have the money. Did you know that the estimated cost of bringing a treatment/drug from lab to market is $83 million?? (and that may be more as I havent checked the stats lately) . This includes scientisits salaries, advertising (recruitment, etc) and travel for patients, staff, etc.

It averages about 18 years for a treatment discovered in the lab to reach the sales arena. We need human involvement - I dont want to rely on the reaction of a drug in primates alone (although I was the first human after successful trials in primates with Spheramine - I guess they didn't see all that much difference between us! LOL)

Here are some questions to ask about entering a clinical trial (from the PDTrials website)
Before participating in a clinical trial, talk to your doctor, family and friends. Make a list of any questions or concerns that develop in these conversations, and take these to a trial coordinator to answer.

Here is a list of suggested questions that will help you to understand more about the trial you are considering:
Source: http://www.pdtrials.org/front/about_...al_trials.php#

What is the purpose of the study?
What information is available about the treatment?
What are the known side effects and what is the risk of new side effects emerging?
What tests will I be required to undergo?
Will I have to stop taking any medications?
Will the study staff keep my doctor informed about my care?
Can I drop out at any time?
How will the study results be used and will they be shared with me when the study is finished?
Is there a chance that I will be assigned to the control group and might not receive the treatment (might I receive a placebo)?
If I respond favorably to the treatment, will I have access to it when the trial ends?
How much time do I need to commit?
Will I have to travel?
Are there any costs associated with participating in this study?
Will insurance cover medical costs if there are any?
Will I be reimbursed for any expenses that I incur while participating in the trial, such as parking?
Does the study include follow-up care?
Other Suggestions

Bring a friend or relative along to hear the discussion when you meet with the trial coordinator.
Be prepared to take notes or tape record the discussion.

No, the risk is yours to take, but I do think compensation is only fair. If a paid venture, patients may be viewed as more than experiments, and patients may also be more responsible and willing to participate. Everyone else gets a cut....except the one with the most to lose.

It all goes along with the thinking that we are valuable, which has been largely missing except when we are worth $$$ to an attorney in a lawsuit.

I haven't done this in any trial; haven't been in one yet. I'm interested in the duodopa trial. If I had to drive alone 2 and a half hours, I couldn't do it. So send drivers...they have the money. Unless you have someone to help, you can't easily participate. It's very very hard to travel the worse the illness gets. I'm paying big time right now for Bio, and probably won't recuperate for weeks.

Clinical trials are for people with caregivers who can provide transportation and take off work, unless you are ok to drive long distances on a regular basis, or are in a trial for something early on in the course of the disease. If this doesn't change, participation won't either IMO.

Once again, only an advanced PD patient really understands what clinical trials are asking of them. Carolyn if I drove as much as you do, I'd be frozen at the wheel, they'd have to pry me out of the car.

paula

I forgot to inccude this info:
A 2003 Harris Poll Survey reported, “helping to
advance science” as the most common reason for patient
participation (54%), followed by “helping others with the same
disease condition” (46%). Obtaining better treatment, which
ranked first (56%) in the original 2001 survey, dropped to fourth
(40%) in the 2003 follow up survey.
source:http://www.bcm.edu/edict/PDF/Post-trial_Benefit.pdf
Harris Survey, Health Care News Vol 3, Issue 10, June 16, 2003. The Many Reasons Why People Do (and would) Participate in
Clinical Trials

and about compensation for trial participation, sponsors need to be very careful about being accused of "buying the patient - thus inflating the success of trial results," so compensation isn't often included as part of the package.

Peg

I thought of that Peg, but it's just an excuse IMO. If they regulate the price within a range of what is reasonable according to the invasivness of the procedure, patients could adjust to the idea that just because they are being paid doesn't mean the treatment works.

I think they should have to buy the patients. They buy the animals don't they? I don't believe that patients do it first and foremost to advance treatments for mankind. They have been told to buy into that thinking. I don't mean to say there is nothing altruistic about it; but advanced patients are hoping to relieve their suffering.

I think a practical, honest approach, in which patients are compensated and made able to participate would be exactly what would help mankind. Waiting for the few that have the means and the help obviously isn't.

paula

Paula
We don't disagree often, but this is one time we do. (Maybe I am misunderstanding). You are saying (I think) that if you are being asked in a clinical trial to take a pill, you would get less compensation than if you were asked to have something implanted into your brain - right? What ifi that pill was radioactive, or what if it contained live viruses, or 100 other possibilities th at could be just as risk as surgery? We don't know what will happen when we take an unknown substance within our bodies - that's why the numbers of participants gradually build as trials advance.

We have enough trouble withh inflation of the placebo effect; can you imagine how that would be skewed by "buying" th e patient??? Perhaps a set cost for compensating trial participants would work, but I don't see it in the near future. For now let's make certain participants are paid for their expenses (to include time taken from work).

Peg

Second time around - lost the first one. Disagreement is more food for thought. Perhaps a pill is the same assurgery; it's not like I have this alll thought out. Placebo gets paid like everyone else in the trial of course.

Remember what the cancer survivor we had lunch with, who now advocates for child cancer patients, said about trials? He said there is no problem recruiting child cancer patients. The parents are desperate to save their children. It's the adult trials that go unfilled.

Perhaps this is because there is no one to help an older disabled patient be in a clinical trial.

When they can't fill the trials, they pay the doctors to recruit. That doesn't help the patient get there. Why not help the patient through monetary compensation?

ok not going to belabor it.....finishing with this thought. it's not the patients that withhold data, push for higher doses for more money, take years to reveal results, bribe, I mean employ for consulting, study investigators. It's the paid stakeholders who break their own rules. With the help of patient advocates and paid participants, the ante could be raised to the professional level of expectation all around.

paula

...i would consider it reasonable to approach it as such. If a for profit company is asking for my help and if such help is in short supply and also essential to the project and if there is some personal risk, then the almighty laws of the market place say compensation. And i mean stock and options for more as well as a driver and ice cream on the way home!

[QUOTE=paula_w;99286]
I think they should have to buy the patients. They buy the animals don't they?

Many interesing ideas have been discussed on this thread, but sometimes passion overcomes logic. Paula, I am sure you are not really advocating that patients go backwards in time and accept being treated like animals or subjects. We can't win a seat at the table where critical decisions are made or win support for a clinical trail participants' Bill of Rights if we don't teach scientists, etc. to treat us wih respect.
Sheryl

they big pharm -should perhaps the term "buy" is not what you want to hear?

maybe the word - EMPLOY the patients, pay them salaried wages,
we aint monkeys -you can't pay them off in money -they have no use for money -rhesus monkeys like marshmallows and captain crunch according to my friend dr. greg gerhardt...

but if we are doing life saving research, then employ us with research wages!!
why not? it is very ethical, especially to the young onset patient to whom if they die -from the drug trials of which I was told, they have died -many have died.
this leaves children with no parent, payment has now -become a nescessity!

if they have good results I would even bargain for stock options in that pharma company...

or

http://www.bmj.com/cgi/content/full/330/7502/1262

BMJ 2005;330:1262-1264 (28 May), doi:10.1136/bmj.330.7502.1262
Education and debate
No cure, no pay

Claus Møldrup, associate professor1