Reservations about participating in C... - Understanding Cli...

Understanding Clinical Trials

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Reservations about participating in Clinical Trials...


After reading the book "Bad Pharma" I developed some concerns about participating in Clinical Tests. The book was written a few years ago, so some of the issues raised may no longer be applicable. But here are ones that caused concern. (These are NOT related to 'medical safety' or the 'ethics of running tests in foreign countries or with populations of people who will not derive any benefits...'

The concerns evolve around sharing of information (results) of tests. The fact that there is not forced "registration" of tests, of the fact that some tests are simply discontinued when desired efficacy is not being established, gag orders and other limitations that have (perhaps in the past) placed on researchers . . . essentially limiting the distribution of test results within the medical community.

It would seem to me that people who, sometimes literally put their lives on the line, should be given assurance that the information derived from a Clinical Test will be widely shared (within and amongst all interested parties in the medical community).

There should be a legal document committing those who are running a clinical test to participants that this information will be shared and test results published.

Finally, should a clinical test establish the efficacy of a particular drug in treating a disease... that trial's participants (including placebo receiving participants) be provided the drug, ongoing.

An actual case in point: Nilotinib (FDA approved for Cancer treatment) was tested on 12 patients with Parkinsons ... with such positive results that it is now in Phase II trial. The original Phase I participants were taken off the drug and resumed their decline in health. Unfortunate for them . . . and science as well ... as the long term effect of the drug which was so beneficial over the brief trial period.... was never tested.

11 Replies

Hi FMundo, I think a helpful resource for you could be "The Gift of Participation" written by Ken Getz, CISCRP's founder. In it he addresses a lot of your concerns. Also another resource for anyone thinking in a participating in a clinical trial is our list of "Question to Ask" found here: At CISCRP we absolutely agree that test results should be shared, particularly with volunteers, which is why we partner with those conducting research studies to translate results into easy to understand format for distribution after the study has come to an end.

FMundo in reply to lperez

Hi lperez,

Thank you for your reply . . . but I'm afraid you haven't addressed my questions. I've reviewed "Questions and Answers" (not answered there) and have ordered the book (though I fear that being the same vintage as Bad Pharma, it will not answer the question either - but I'll give it a try). Here is the reasoning behind (and importance to someone considering participation in a Clinical Trial) of my questions:

If the existence of a Clinical Trial is not registered... or the results are not made available to the medical industry across the board, then it is very possible that information critical to future patients (and their doctors) is not available. Let me describe a hypothetical situation . . .

You have an unusual type cancer and weak kidneys. Your physician hits the research path looking for the best drug to help fight your disease. He's not looking for the absolute best drug to fight your specific type of cancer . . . but, knowing that your kidneys are in terrible shape, is looking for an effective drug that fights cancer and is "easy on the kidneys." Well, unfortunately, there was Clinical Trial (that he never finds) of just the type drug that would have helped you... but that Clinical Trial was never published. Seems the sponsors abandoned it because it was proving itself in the trial to not be up to sufficient snuff to compete with other cancer fighting drugs. But it showed some efficacy, and was kind to kidneys. So your doctor never finds out about the drug, and you are never treated with it.

People like me, considering participation in a clinical trial do so for both altruistic and selfish reasons. The questions I posed are important ones for both categories of reasons.

The "right" answer to my questions would be that there is a legally binding document signed by those people responsible for running the Clinical Trial specifying that results of the trial will be released to all interested parties in the medical industry. Further, that if a drug or other therapy involved in a clinical test does prove to be efficacious, that it would be provided to the patient at no cost going forward into the future. (not a unreasonable expectation in light of the risks and time investment of the Trial Members).

My question - Today, are such documents part of the paperwork which is exchanged with the people participating in Clinical Trials? Is there boilerplate that I could take when I am signing up for my next Clinical Trial?

JJbyrneAmbassador in reply to FMundo

There is hope around the corner to address your concerns; in December 2016, Congress passed the 21st Century Cures Act for which patient access to study results will be federally mandated. Additionally, companies such as Smart Patients, Be the Partner, Antidote, and many other technology services leaders are developing platforms to better link patients to study results, study related data/information and clinical trial matching to help address some of the roadblocks and frustrations you have expressed.

FMundo in reply to JJbyrne

Of course participants should, as a matter of course, be advised of Trial results. My concern is that the MEDICAL INDUSTRY across the board needs to be advised, for the reasons stated.

Hidden in reply to JJbyrne

Will that 2016 mandate be recended under new leader ship? Many positive things already have been retreated on such as environmental issues.Who doesn't believe in clean air and rivers? besides coal miners and energy conglamorates???

I have been in two trials. In both, as long as a participant is receiving a benefit from the drug they will not discontinue from the trial whether or not the trial is over. I was on one trial that was suppose to last 2 years, I was provided the drug for 3 1/2 years till my PSA started to rise significantly.

Currently I am in a trial that was suppose to last 9 months, it has now been one full year and I am still doing OK. The trial is a mystery drug from Eli Lilly plus xtandi. So, even if I am getting a placebo I am sure of getting the xtandi at no cost. The mystery drug is suppose to extend the efficacy of xtandi.

I have many reservations about big pharma but I would not hesitate to participate in trial if I thought it was worth while.

FMundo in reply to Magnus1964

Its in no way assured that continuance on a drug following the Trial is assured in all cases. It is something that we need to insist upon for the benefit of all people who agree to participate in future trials. The Pharmaceutical industry and other sponsors who conduct trials will not do this of their own accord.

Magnus1964 in reply to FMundo

As I said, I was told that as long as I was getting a benefit from the drug(s) I would not be taken off of them. I believe this is standard procedure in any trial and has been my experience. The only reason I was finally taken off of the first trial I was on was because my PSA began to rise significantly and that was well past the end of the trail. The drug was approved by the FDA long before that.

Hidden in reply to Magnus1964

Eli Lilly is big in Indiana..All of big pharma makes big profits..And they charge accordingly as aloud by law..Hopefully they help those that can't afford the cost..Should be part thier duty also...besides just profits...

Yes, I absolutely agree that patients should be provided with the drug after FDA approval. I am on a clinical trial and am concerned how I will pay for the drug after the trial.

What are we to be most afraid of--->"I am from the Government, and I am here to help you"! Rules and regulations when it suits them!


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