Encouraging Clinical trial recruitment
 

I came across this breakout group report on Clinical Trial Recruitment from the MJFF scientific advisory board , suggesting ways the MJFF should get more involved in promoting clinical trial participation.
see:
http://www.pdonlineresearch.org/resp...al-recruitment

An important issue for sure, and also one that the Parkinson Pipeline Project - a patient advocacy group (pdpipeline.org) and the Parkinson's Disease Foundation have been working on collaboratively for some time.

PDF also leads the Steering Committee of PDTrials.org - a coalition of national PD orgs in consultation with medical and patient groups - that provides information on currently recruiting PD trials and encourages more trial participation among PWP.
(see http://www.pdtrials.org/en/about_PDtrials_committee)

So I'm wondering why duplicate efforts? I hope the message will be that we all need to work together to achieve this goal. and encourage greater cooperation among the orgs and that PWP will also be meaningfully included in any effort or program that affects us.

See:
Breakout Group: Clinical Trial Recruitment
full text at:
http://www.pdonlineresearch.org/resp...al-recruitment
excerpt--
"Beginning in 2010 MJFF will increase its focus on addressing the issue of clinical study participation. Many clinical studies face significant hurdles in meeting recruitment goals and/or recruiting in a timely fashion. Leveraging the insight and experience of the Foundation’s Scientific Advisory Board, MJFF developed a breakout group to address two issues: 1) identify the challenges clinical studies face in recruiting PD and controls subjects and 2) generate ideas MJFF can implement to improve awareness of clinical studies among the PD population as well as increase subject engagement in clinical studies. ...." (see the full text)

i have questions:

what does holistic mean? does that mean all stakeholders? is it marketing ads or science..how will you do the recruitment? Will it be sold?

Are there org mergers being considered? If so, do you think patients have a need to know about it?

There is an organized group who has been at this.... for a decade. have you read the pipeline site? so we are interested in what you mean; too experienced at this one for no explanation to be provided.

Communication is a courtesy.

that's my opinion not the forums being spoken for at all.

paula

the more the better
 

I understand your questions, Linda, but given the (still) low numbers of pwp participating in clinical trials, I am in favor of any group presenting new ideas or ways of improving awareness about clinical trials.

We have had many spirited discussions in this forum about the pros and cons of participating in clinical trials. As many in this forum know, I have been in quite a few clinical trials and am right now in two ongoing trials. I just hope that with greater awareness about the existence of clinical trials, more people will look into different trials and understand that doing this is for themselves and for all of us who live with PD. Remember that there are many trials that don't involve new drugs - like exercise trials, or trials for biomarkers.

And yes many people live far from study centers, and that is a is a barrier to their participation. But not everyone faces such barriers. And there may also be trials like at the NIH or the IND where travel is provided to the participants.

Is the system perfect? No. Are some of us working to make the system better? Yes. Right now it's the only option we have. And with so few clinical trial participants, the movement of new treatments in the pipeline is grinding to a halt. Our wait grows frustratingly longer and longer and longer.

why have so many national PD orgs period?
 

[SIZE="5"]Linda asks:So I'm wondering why duplicate efforts?

I have wondered this same thing for a long time, but on a broader scale than just clinical trials. Can anyone tell me why we need so many national PD organizations duplicating efforts and wasting time and money while the clock is ticking down for those of us desperately hanging on for the cure.
At the very least, each org could specialize in what it does best, whether research, providing direct services to patients and caregivers, or whatever.

I agree wholeheartedly with Linda that we all need to pull together to achieve our shared goals. This means having the orgs meaningfully include PWP in any effort or program that affects us."


sheryl

Linda,
MJFF has taken a very different approach towards research than most funding agencies and I think it is starting to pay off. May be they can do the same to clinical trials too.

girija

this would be easy
 

So what's the buzz on this today? i gathered a few opinions on it. Should we, as patients, actually try, for one day, to see if we can spin our view and what we have done for the pd commuity? We can toot our horns, constantly and are sure we are superior. It's like being up against a big bullying cousin or uncle or grandchild.....metaphorically mostly.

That works in business, investments, celebrity [extreme I'm special factor]is a unique subject that i'd like to talk about. It's like we are up against the ..strength only a safe feeling celebrity can master. Many don't. But Michael has. So I think we should have some comunication from him without his celebrity being the focus, but rather what we all think.

I don't know how, he has been pretty good as a ghost. it would be faster if we were courteously given a more direct communique. i'm very flexible.

thank you,
paula

MJFF and clinical trials recruitment
 

I think that Girija is right on the mark.

The MJFF Patient Advisory Council met in conjunction with the MJFF Scientific Advisory Board late last month in Charlotte, North Carolina. It was an exceptional experience. Each group had their own agenda, but we came together formally to discuss clinical trials recruitment for one breakout session (as reported in PD Online Research). It was an open and frank conversation about the challenges facing both patients and recruiters. (Note: the patient council spent our entire meeting on the topic of clinical trials - the MJFF staff got an earful!)

Clinical trials recruitment has emerged as an area of concern and engagement for MJFF because of the role they are taking in recruiting for their long term (5 year), data-base-building, biomarker study. As they worked to solve the recruitment challenges presented by this one study, they organically understood that what they were learning could, and should, be applied to all clinical trials.

MJFF has talked with PDF about PDTrials and the Learning Institute; I encouraged Debi to look closely at what the Pipeline has accomplished; MJFF is actively seeking patient input in their decision making. Whatever they decide to do, you can be sure it will be innovative, patient friendly, and proactive.

On the last day of the meeting, the patient council listened as the researchers passed the microphone and each stated what they thought was the most important area of PD research right now. The topic of clinical trials was raised again, including patients rights - especially if the trial goes awry in some way. One scientist, a Harvard epidemiologist, said that he felt that the community, society, was responsible to care for patients who give themselves to science for no more reason than altruism. He got some push back - mainly because others talked of legal requirements and university regulations, but I was encouraged that this point of view was spoken so openly and taken seriously.

Although not part of the discussion on the last day, I felt welcome in the room - and at the table. I know first hand that the best researchers in the world are concerned about the things I think they should be concerned about; that they understand the urgency.

I was again reminded, and the researchers clearly vocalized, that MJFF's power to convene is paramount - they were obviously grateful for the opportunity to come together to discuss their research across disciplines and around the table.

I share the concern of organizational duplication, but in this case, more is definitely better.

ok we are closer to understanding
 

Thank you carey, i hope it becomes something we can count on...regular updates. speculation is becoming too tedious for us sickies. ....do you know what i mean? zero tolerance, no energy.

Well now we are at point x.
paula

Carey
 

I've said it before, and I'll say it again, I am VERY glad that you are on the MJFF Patient Advisory Council! :hug:

I'd love to hear more about the MJFF Patient Advisory Council's discussions about clinical trials!

Jean

Let MJFF lead the research charge
 

Carey, MJFF already has my vote for leading the research charge, which has to include improving clinical trial recruitment and retention. In a relatively short time, they have proven their ability to amass the money, attract the top researchers, and bet on the right "horses." It is due to their Hercculean efforts in this area, that we are that much closer to a cure than we were 10 years ago. My money and my heart are on Mike!
sheryl

enthusaism welcome
 

money? heart? ok but it's not a bet; it's not a race. It's about teams.
It's about teamwork. exactly the opposite. but this is America.

paula

?
 

It's about teams? exactly the opposite of what? Paula, I don't understand.

fell sleep - typing a response

it's really pretty simple. i understand what we are trying to do is massive, but I don't think it's unified. And i don't think the one with the most money wins. i don't view clinical trials as a contest to see who is in the most. That doesn't mean I don't appreciate people who are in them.

teachers just aren't built like business people. we share, it's not in our nature to keep ideas secret to be the best. i understand that in research one must not let other s steal the idea. i guess it's ok to steal now and the ten commandments are out the window in favor of a bottom line.

bottom is a good word for it and where it should be.

so if clinical trials are going to go commercial [and i'm speculating because i don't know] i think people who have been working on this should not be ignored or have to listen to any org doing it best rhetoric.

it's not about who does it best iMHO; it's who produces the treatment and i wouldn't bet on anyone being more special than another. For ten years i've promoted communication and teamwork. I still am.


paula

The question of participating in clinical trials or medical studies of any type is a hot button issue within my PWP gang. The pharmaceutical industry has committed grave strategic errors, violating the trust and hope of millions of people. The Amgen GDNF fiasco, the secretive and bizarre “global shortage” of sinemet, the multi-billion dollar fines for criminal actions, the multi-billion dollar damage lawsuits for harming people while hiding the truth…. Volunteers who offered up their living bodies and their living brains in the hope of contributing to all mankind have had their trust shattered. Volunteers thus became hard to find.
And yet we know, that without clinical trials, a cure will be delayed.

It starts and ends as a question of trust. I am lucky in that I have a neurologist who is also a scientist and above all he is also a DOCTOR, in the old sense of the world. I tell people, if you want to know what the definition of “doctor” is, it is him. So if he tells me he knows about this experiment, he believes it is a good idea, and he trusts the people involved, I’m good to go. I trust this guy. Before you let someone inject you with unknown substances or let them drill a hole in your head, you have to have trust. Honesty. Humanity. And a fierce determination to eradicate this horrid disease from the face of the earth forever, or at least, until then, alleviate the suffering. Big Pharma has blundered dramatically by violating every law of God, man and nature. Some of their actions have been so wrong-headed, you are left wondering just exactly what they think they are doing.

The damage done has been great.

In my Parkinson’s Posse, it is almost unanimous to say that we will boycott clinical trials involving sham surgery.

It is entirely unanimous that we will boycott Amgen until the day they chisel the names of the 48 volunteers into the exterior wall of their head office.

It is entirely unanimous to be immensely careful of anything said or done by Pharma or bio companies, especially the ones that are constantly being fined for criminal actions; who then add the cost of the fine to the price of the drugs and continue their illegal actions.

So when considering joining a clinical trial, consider that it is the biggest, most dangerous job interview of your life, but it is not them interviewing you, it is you interviewing them.

Who is paying for this study?
Is it a study to add a slight variation to an existing generic drug, so that it can be patented?
If it is a university study, have the doctors involved been receiving kick-backs? Ask the question.
What is the chain of command? Who is lurking at the other end of the pipeline? If it is Pharma, there will be no legal connection between you and Pharma, so they are completely protected, and you are completely vulnerable. What is the track record of the people and organisations involved?
Will this study be peer reviewed and published, or hidden away, as most studies are?
Is this the 100th repetition of the same study, made necessary because scientists refuse to share the results of their research?
What do other groups of researchers think about the competence and integrity of this group?
Is this study aimed at something that would be really beneficial if it worked, or is it just another frivolous study about some obscure detail, to fulfill the “publish or perish” ambitions of a scientist who hopes it will pave the way to tenure at a university, or a highly paid career with Big Pharma?
Will you be given information of what is happening during the process, or are you just a pawn on a chessboard, cheaper than testing it on monkeys because they would have to feed the monkeys?

It is a question of trust; always hard to be sure of.

The Michael J. Fox Foundation is an organisation that I trust. Granted, I wish they would speak out for us when some of these monstrosities are perpetrated by unethical scumbags who are bottom-feeding. But Fox has chosen to direct their energy and money into direct scientific effort, figuring that the crime lords or political wrestling matches will continue anyway, and the only way to get the criminals out of the lives of Parkies is to cure the disease.

So, yes, I would participate in a study chosen by the Fox Foundation. After asking all the above questions, and checking out their references, such as:
http://www.michaeljfox.org/research_...archersSay.cfm
I still wish MJ Fox and Andy Groves would get up on stage with flame-throwers, from time to time. But anyway, as far as research goes, they look good to me compared to a lot of what is going on out there.
Bob Dawson
Sure to take some flak from the Posse for selling out to The Man. Again.
+

Play to their strengths
 

Paula - I think you are correct. PD does not have a unified community behind a cure. "Team" is a term used by many of the orgs for their individual efforts, usually to raise funds - and the orgs are in competition with each other for money.

In the case of research, though, if I have to put my money on one horse, it would be MJFF. Not because they have the most money, but because they know how to use that money. Ironically, the thing they do best is team building - something unknown until recently in the scientific world. And, to his great good credit - and all of ours - Michael J Fox has lent his extraordinary celebrity to MJFF, endowing them with the power as the Super Convener - and they know how to use it!

It would be foolish of MJFF to discount and downplay that power, and detrimental to the cause and effort of finding a cure. ALL of the orgs, at this point, are better off putting their noses to the grindstone and forging ahead full charge on our behalf, not worrying too much about what the other guy is doing. The orgs each have their strengths; they should recognize that and promote each other on that basis, join forces when it makes sense, and not put up roadblocks built on ego or tradition or standard practices. We don't have time for them to play nice - we need them to play tough, fair, truthfully, intelligently, innovatively and productively. There's a lot to do; many paths to take; each can have their part; we're lucky to have so many people working hard on our behalf - just so they don't get in each others way.

Like you, Paula, I am a lover of process and inclusion. The great conundrum is that MJFF gets the highest points for both process and inclusion, while at the same time they are also the most exclusive. They have the good luck to be the new kid on the block, so their ways would, almost by definition, be seen as fresh and innovative (or the bad luck to appear as bullying rule-breakers?). I believe the new guys have the moxie and bring a game that will ultimately prove successful just because their innovation is based on inclusion and collaboration (in their exclusive, celebrity way), and is not based on dumping huge amounts of money without direction or squandering MJF's time and health.

I wish everyone with Parkinson's had the chance to be a fly on the wall of a MJFF Scientific Advisory Board meeting. It was inspiring and comforting. I know that they are doing their best, and that their best is extraordinary. I guess I should write some more about it, but so far the words have failed me.

Well carey, you are doing a good job so far with words. People think differently, with no feedback they don't know where to put their confidence. I'm glad you did attend the meeting; that's what we have wanted all along. Please keep the information flowing when it's available.

paula

only words ......
 

Paula - words are the only things we have right now. I'm hoping for some real data soon!

agree agree
 

Carey - I agree with you- both about MJFF, AND about the other orgs focusing on what they do best.

And Paula, I agree that clinical trial participation is not a contest. It is a very serious business. I know pwp who work hard for clinical trials awareness: some have never participated in a clinical trial, and some have. I respect all their hard work and points of view.