TO participate in a clinical trial or NOT to, that is the question....

[FMundo]

We all agree that finding therapies that will slow down the progression of PD, to stop it all together.. or even avoid the disease are all profoundly important goals. Participation in Clinical Trials may (or may not) contribute to that critical goal. Are you participating in a clinical trial? What is being tested? Are the trial results guaranteed to be published? What have you been promised for your sacrifice?

[cjsg]

My hubby is in 2 studies. I am not sure you would call them clinical trials because he did not change his life style in any way. One is 23 and Me a DNA study, where he gave a saliva sample to be studied for genome markers. The other is a telamed study to see if computer/webcam doctor visits will work for PWPD. This is in hope of more PWPD being able to be treated by movement disorder doctors using the web cam, so they don't have to commute long distances to see their specialist. We were promised nothing. We are trying to help in a way that we are able and willing to do.

[Dewdlebug28 in reply to cjsg]

I was just diagnosed wiyhn breast cancer and would eriously love to find a study......any ideas.....509..270..5072..dew

[soup]

Some people feel it a privilege, not a sacrifice.

[PositivePen]

I feel very strongly that it is vital that I take part in both drugs trials and also studies by the medical profession. I was diagnosed with PD early in 2012 and have been part of the Discovery Study out of John Radcliffe Hospital for about 2 years. This has involved having an MRI scan as well as a lumbar puncture. I am also called back to participate in mental tests, physical tests and dexterity tests.

Three months ago I was also accepted onto the Exenatide trial being held at Queen's Square. This is a medication which has already been approved by NICE for use in the treatment of diabetes but which seems to have a hugely beneficial effect on the suppression of PD. It may even stop it in its tracks and possibly reverse it. As it is a double blind trial it could be that I am on a placebo of course. I inject myself once a week which I have managed with no problem. Before I was accepted on the trial I had a DAT scan and I will have a lumbar puncture at the three month mark next week and then again at the end of the trial.

I have been promised nothing by the teams on any of the trials (I am on another study out of Kings) but that is not why I participated. I feel that it is a way to help the medical profession to discover a cure for PD so that my children and grandchildren will not have to worry about this condition. However should Exenatide prove to be effective I would hope that I would have priority in receiving it.

[tlongmire in reply to PositivePen]

Will they let you know the results of the study? This assumes that you are on the placebo otherwise you should see some improvement??

Terri

[jillannf6]

ye si agree it is a privilege to be in a study1

i HAVePSP and there is no treatment or curE for ti but also not many trials either

i should like to be in a study and wait to hear of anything going on in NW ENGLAND

lol jill

[honeycombe3]

What question?

There is no question.

There is no question that without trials there will be little or no progress in finding treatments or cures.

There is no question that when advances are made as a result of trials each of us PwP will make use of these as happens at present.

There is no question that those of us who enter trials benefit in more ways than the direct outcomes - whether the criteria are met or not. The synergy created by meeting other PwP & leading practitioners in the particular aspect of PD, by becoming knowledgeable & thus empowered to inform others & the feeling of self worth - of being able to contribute....the sum of these is definitely far more than any inconvenience of taking part.

Even the experience of putting my life on hold for three years, making regular long distance visits for cognitive & physical tests, having a 2 hour MRI scan &

waiting for the chance of a cell transplant (or not) has not put me (or my husband) off taking part in trials, though I must add that having to leave the trial due to another health issue without receiving so much as a 'goodbye' or 'thank you' almost did!

[FMundo in reply to honeycombe3]

I am reading a 400 page book on the subject of Clinical Trials (in general, not specifically those related to PD. But I'm certain that some of what is reported applies to PD trials.

Clinical Trials are "sponsored" 98% of the time by pharmaceutical companies. The goal of those companies is to prove the efficacy of their particular treatment modality. As such they can be highly biased and often DO NOT provide subsequent treatment physicians all the data they need to make good judgements for patients. They (pharmaceutical companies) often do this by 1) terminating trials before they are finished 2) selecting only the successful trials for publication (and not publishing the unsuccessful ones 3) putting gag orders in their contracts with researchers so that sharing of information from particular trials is under the control of pharmaceutical company and 4) Skipping the important process of "registering the trial so that all medical professionals know that the trial is underway (and can therefor search to see that it was completed and the results reported.

The results of this appalling situation is that some drugs that are not effective or are less effective get on the market, and patients suffer. Worst of all, people who offer themselves up for trials for the highest of altruistic reasons (and are told that they will be contributing to science) are sometimes totally misled and therefore betrayed. When the trial that they have devoted hours of travel for, put up with Lumbar Taps, etc etc serves no purpose.

There is a simple answer to this problem and that is to "hold those people who conduct Clinical Trials ... or sponsor them ACCOUNTABLE. Specifically to have them sign a statement that they will carry the clinical trial through completion. That the results will be shared NOT ONLY WITH YOU, but with anyone who has legitimate professional interest in the results. The trial must also be properly registered.

My question of whether or not to participate in a clinical trial is a legitimate one. I have given you my thoughts about a prerequisite for participating. If you are in a trial now you should demand what I suggest for your continued participation. Finally, let me say I absolutely believe in the importance of Clinical Trials. They are essential for medical progress to be made.

My head is bowed in respect for those people who participate in clinical trials for the contribution you are making. My life (and those of others with PD depend on them). It's time we insured that the results of Clinical Trials are dependably shared.

[soup in reply to FMundo]

You have an incomplete impression of clinical trials. Not all clinical trials are drug trials. Many are non drug therapy based. The efficacy of multi disciplinary approaches to managing Parkinson's; how to avoid falling outside the house; the effect of Dance on UPDR scores. These are just few I have been able to read reports on.

There is also evidence that patients who engage with research have better outcomes than those who don't.

If drug companies are to play no role in clinical trials, there will be no new therapies. Would any of us here want to see that or to give up our current drugs? I agree that results, both negative and positive should be available? How are WE the patients going to do that. Suggestions please.

[FMundo in reply to soup]

I recommend that we put the "pedal to the metal" on Clinical Trials. Full speed ahead. Lets just do it so that the medical industry has a full ability to assess the results. What I find particularly exciting is the Fox Insight program whereby the monitoring of thousands (or conceivably tens of thousands of PwPs can be monitored using smartphones. I believe 12,000 are in the program already. Reporting data to their physicians, ALL patients and their MD's will be in a much better position to judge the efficacy of their treatment as they can be monitored anywhere anytime. Big Data analysis of large populations will apply. You can live anywhere in the U.S. Its free, no travel.

Honestly, if you have Parkinsons, you're nuts not to sign up. The train is leaving the station.

[racerCP in reply to FMundo]

I am participating in the USA Isradapine trial which is sponsored by NIH, not a pharmaceutical company. However NIH has many ties with those companies of which we are not aware. Isradapine is an existing med for blood pressure control and has been used for years. It is an older med and been replaced by many others which are not calcium chanel blockers which cross the brain- blood barrier. It's a three-year fairly non-intrusive study with four blood draws of little consequence. I hope I receive the Isradapine and not placebo but who knows. If I wanted to receive the Isradapine on my own I could get it through a prescription and it will be a covered med by my policy.

[wifeofparky]

I am a control subject in a biomarker study. I was first tested/examined three years ago and did a followup this winter. It included a neuro exam, blood work and a brain MRI. I feel privileged to participate. If I can help find biomarkers to help diagnose, treat or at least predict the course of the disease it is well worth my time.

[Beckey]

Show me a clinical trial for people with SWEDD and I'll participate!