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Debi,
I understand your post to be saying that it is possible to have constructive relations between industry and patients, something I have believed for some time. When we don't have any way to talk to them, we have to second guess and have focused mostly on our own needs. Understanding their needs is just as important, but prior to just recently, we may as well have been monkeys.

I think your communications could do much toward bridging this gap.

Secondly, the study you are planning sounds low [no] risk and high impact. No treatment, just collection. If provided with all the information in a statement, along with updates, which can be posted anywhere [many have other means of promoting it], allow us to post in full with no copyright, including updates, then you could meet that goal of high numbers in a short period of time.

Knowledge is power, and we'd be glad to use whatever power we can muster to help, if we have the knowledge. Doctors must become more involved and we could give them regular information and updates also.

Final thought: getting a pwp anywhere can be hard. Is there anyway you could go mobile with that study? Get closer to everyone instead of them coming to the centers? Maybe that is too impractical but if you could, it might work very well, depending on what you are collecting.

Thanks again for posting.
paula

Sheryl and girija - great stuff!

Seems like there is a fundamental misunderstanding of the PD population; we have a great understanding of and knowledge about the need for trials, how they work, the research details, how the industry works, etc. Logical or informational arguments for more participation isn't the solution; they don't address the problem, which seems two fold:

1. Disease related
The problem is motivation; and "movement" initiation; asking people who have damaged dopaminergic systems to do things we can no longer do without incredible effort. To be overwhelmed by the details of any project. Wanting to be in a trial and even making the decision to do so is the easy part; following through is the hard part. Often it's those pesky executive functions. Multi-tasking; concentration; making decisions and following through. Other times it's not being able to walk. It's movement initiation of any kind that has been damaged by dopamine depletion; motor and non motor.

Researchers should know their patients (clients) better That's the point of this whole "listen to the patient" thing - up until recently the medical establishment has been researching and treating a disease very different than the one we are living. It's because they never bothered to look beyond the stiff and shaky body that came through their doors. Why did it take so long to get them to understand that there was something else going on?

2. Researcher/Industry - Patient relationship
Patients are more informed; we have moved into a different era where trial participation as "human subjects" sounds, if not medieval, then oh so 20th century. We need to develop a new contract, partnership, relationship that accurately reflects the current situation.

On both counts above, seems like the researchers are the ones who need to catch up with the patients. It's a new paradigm; get with the program!

So much to reply too...

This is probably a topic I should not bring up, but...here goes anyway. Dr. Bartus interview with MJFF. Since that interview, which does appear to be open and honest, I have wondered why the interview took place. I have first-hand knowledge that Dr. Bartus, and maybe others at Ceregene, had had conversation with PWPs about the end results of the trial. Knowing this and having read the interview, I have wondered about the reason for the interview. Was the interview Ceregene's way of silencing the PWPs who had been "stirring the pot?" If not, why have the interview. I find it hard to believe it was just a "why not!" idea.

It is very true that talking to PWPs who have never been involved in a trail about trials is like talking to a brick wall...they look at the one suggesting the idea with that "you want me to do what!" look. Then comes the it is too far away to travel. It is had to find a patients, and the family, who will participate in a trial of any kind.

I am attending the Philadelphia CISCRP AWARE for All at the end of March because I want to hear the presentation on Informed Consent (also to help PDF with their table, but this part was an after thought). They are having a pretend Informed Consent, which will be particularly interesting.

I hope MJFF can see their 18-month trial recruitment goals. Recruitment goals being the first challenge can be most difficult. I was shocked by the swiftness by which Ceregene recruited for Cere-120. Was it that patients were just desperate for something good to come of trials, and that Phase I had such a positive outcome? Was it the way in which the PIs recruited patients by having an open around-the-conference-table Q-A presentation of the trial to the prospective patients before Informed Consent was presented? I don't have the answers to these questions, but the questions continue to bug me to this day.

Cere-120 was recruited within a VERY short time. I remember it being an unheard of time-frame. Which does then indicate that the placebo effect will be big part of patient participation. I want to see the end result of Dr. Kim's interviews with Cere-120 participants. We were all interviewed, including the non-participating patients who had considered the trial, after surgery and again after the un-blinding. [Scott Kim, MD, PhD is an assistant professor in the Department of Psychiatry and a core faculty member of the Bioethics Program and an investigator at the Center for Behavioral and Decision Sciences in Medicine at the University of Michigan. The interviews were done by a staffer at Univ of Rochester.]

At one point I presented my PI with the Declaration that we had been developing. He said it was a good idea, and in somewhat of an appalled tone, said the he had always treated his trial patients as "part of the trial team." I know this was a sincere comment, but being on the other side of that table, as a trial participant, I never truly saw this as fact.

As to the argument about placebo. Well, I see myself as a major player in the Placebo-Effect. I sincerely and without a doubt see that I suffered the placebo effect from June 2007 until January 2009. And I still have the questions: Why is no one closely studying patients who obviously have had a placebo effect? Isn't it the patient who had the placebo effect that are important in the argument?

Dr. Robert Hauser, Univ of South Florida, is working with a trail regarding sub-groups (may not be the correct terminology). But I see this as a small and almost an unimportant trial...to researchers that is. Is research taking sub-grouping of patients seriously?

Carolyn

participant in five trials

[QUOTE=paula_w;476440]
Debi,
I understand your post to be saying that it is possible to have constructive relations between industry and patients, something I have believed for some time. When we don't have any way to talk to them, we have to second guess and have focused mostly on our own needs. Understanding their needs is just as important, but prior to just recently, we may as well have been monkeys."

I, too, believe there can be constructive relations between industry and patients, but only with a change in attitude by both sides. Much like a marriage, this relationship must be respectful, aware and attentive to the needs of all stakeholders, and constantly nurtured. So, how do we get to this point from where we are now?

MJFF and the other national PD orgs must serve as "marriage counselors," bringing patients and industry together for frank discussions. This is probably the most important thing they can do. No matter how many dollars are raised for research, there will be no trials unless patients feel they are a valued member of the team and willingly participate.

sheryl

Agree with Carolyn - we have a huge population of pwp who won't consider joining a trial for any reason. And it doesn't matter where they are in the disease - early - middle - late - the answer is and has been no thanks. (early in the disease it's easier to participate than when advanced - that's a given - but this population has steadfastly refused to participate at any stage).

So let's focus on those who DO want to be part of the process:

So how can we help the pwp who are motivated and want to participate in the system? As Carey states, we increasingly have executive-disfunction and motor disfunction. We need science and industry to work with us when they are designing the trials to make it easier for those pwp who are motivated and interested to actually become partners in the process.

P.S My father, who has Alzheimer's, has participated in several clinical trials. They ALWAYS gave my folks rides to and from the study center. It was part of the contract, and a necessary part of the process. Frankly, not having transportation to and from a study center is a major barrier to many pwp. I know my day is coming - now I drive 100 miles round trip on freeways to see my MDS & Study Doctor. And the staff accommodate me by scheduling my appointments between 10:30 and 1:30 (avoiding the worst of the traffic) but I won't always be able to make that drive.

Jean - I think the issue of motivation and movement is key to making everything better in our lives - from joining clinical trials, to exercising!

It's so hard to overcome - and so difficult to communicate to others!

We would all agree, I think, with Debi about how hard; complicated biology is. We are suffering from so much biological misfiring. I think we need to have some real hard conversations with all the stakeholders. [not a new idea!] Lack of trust comes from lack of communication - in fact it is deliberate withholding in some cases and we know it's due in part to competition and also to obligations to stockholders. But how is that considered to be fair? When did this become fair play?

Now my "gut feeling", "instincts" "inner voice" is flashing a warning light about possible waste of time and money on ESCR, that could be spent on adult cells now that they seem to be able to do the same thing with them. Can someone please explain how far ahead they are in one or the other? Do they both have the same uses now? SCNT is illegal. Women dont' want to donate their eggs. They mentioned in one of the recent advances that skin cells can now be made into neurons. What is the difference between the two? I would very much appreciate that. Maybe someone could make my light stop flashing, even tho I won't see either one on the market.

I would be glad to promote a clinical trial that I was thoroughly familiar with and could easily explain on this forum in lay language, including the risks vs the benefits. i think this is possible and have said it a few thousand times. Honesty is the way to go....always. Trust will follow. Energy and motivation are even harder to non-existent - if you don't know what to believe - what the facts are, why this must be, etc. - in other words, we must know the rationale for the design. We are pretty with it considering the condition of our brains and psyche. But to be in a clinical trial takes a ton of energy and motivation. And it just can't be shrugged off when you do it for nothing [surgery]

Industry and medical community do need to know the illness much better than they do. Just switching a med is hard work and can cause us to lose something that may not come back. We feel much more and much worse than what you see.

oh forgot to address carolyn - i may be having feelings of grandeur carolyn but i kinda thought the Bartus interview was for us [and other inquiring patients]....no?

paula

I am wondering why the idea to recruit members on this forum for the biomarker study has not been commented upon? Jaye, I visited the web sites whose links you posted, and neither has this clinical trial listed. I really am interested in participating, as is my husband. Is this idea so far fetched? Just listing the centers participating would be enough....or could someone with the knowledge of where this info is available provide a link?.madelyn

madelyn, i'm lost please help lol. what biomarker study do you mean so i can follow the thread...long day lol

paula