Most people who participate in clinical trials do so for either of the following reasons (or some combination):
1. They will be beneficiaries of good outcomes (treatment will reduce/ eliminate suffering).
2. They are altruists who believe participation will advance science, benefit mankind.
What if it doesn't ? Or what if the results diminish their health or advance their illness? Whether they receive a placebo, too high a dose or insufficient amt of drug... not considering "pain and suffering", who is financially responsible for remediation or therapy after the trial is over? Apparently this is not considered the responsibility of the organization conducting the trial, but rather falls on the shoulders of the participant. Is this true? Is this fair?
Written by
FMundo
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I phrased my question in such a way as to stimulate thinking by those people considering volunteering for CT's. Its time for the those involved to consider the issue. Beyond the moral imperative to "take care of those you unintentionally cause harm to" the issue of restoration should taken care of. Its simply a cost of doing business.
Anyone considering participation in a CT should have independent counsel (both legal and medical) prior to signing up or signing any rights away.
Agree and if trials are patient friendly and ethical, then It would follow that the pharma conducting the trial should be more than happy to pay for counsel, both legal and medical! Call me synical but I would be gobsmacked if they did. They should, as a participant should not be out of poclket and should be as aware of possible before entereing into the trial.
If you accept the fact that most people who volunteer for CT's do so with the expectation (or hope) that they will receive beneficial access to a drug that may help them (as opposed to altruistic reasons) and if you further acknowledge that many of those people are suffering from a serious (or terminal) illness ... then I think it safe to take a step further to say that you're dealing with a population that is not going to carefully scrutinize the small print on page 20 of the contract where they sign away their rights to seek support for ongoing complications that may be made more severe for having participated in the Trial.
I agree absolutely. I wonder have you ever taken part in a Delphi Questionnaire with regard to trials. It can be an eye opener.
Just wondered if you had thought of locking your thread. Some people are reluctant to reply to some posts if unlocked as they can end up anywhere on HU and indeed the web.
Would you tell me more about the Delphi Questionnaire...
In terms of "locking" the discussion, I would be against limiting it. The topic is relevant to many people, and (frankly speaking) people should have the courage of their convictions. (Besides the majority of HU'ers use pseudonyms and don't post their pictures. For the record of FMundo, my name is Frank Mundo, Phoenix, Arizona (and Islesboro, Maine). I have Parkinson's and like other PwP's, I have a huge stake in the outcome of Clinical Trials.
I respect the fact you are happy to be quite open on a website, but less happy that you feel those of us who wish to be more private should 'have the courage of their convistions.' I am not on facebook and have no interest in general social media. I feel pretty much all of us have health issues on here and have a stake in the outcome of trials and post on other areas of HU. Quite a lot of personal information leaks out whilst supporting, especially newbies eg that I have had my own struggles since babyhood.
Away from personal stuff and with regard to inframtion about any condition, I am a firm believer in transparency.
I have 3 hats, although I don't know for how long due to multi health issues.
I am a patient representative within an organisation relating to one of my conditions.
I have taken part in a delphi relating to upcoming trials.
It may be that I could be taking part in a trial (after much reading I might add).
So Delphi Questionnaire. I have put a link up but will try and explain. If you have a group of researchers, for want of a topic, say looking into migraine. One group's core end set may be 'how many attacks a person has' another group's core end set may be 'how many hospitalisations a person has.' So the idea is to get all groups of researchers singing from the same hymn sheet.
Ours had three rounds. First round questionnaire - you answer questions giving them a score of critical, important but not critical and not of great importance, anonymously. Everyone can add a question which they think important which will be included in second round.
Second round you see your last score and the rest of the group, again anon.
Third round same again.
I think if the score for critical is above 70% it will be included and dropped from the questionnaire.
I am looking forward to the results, although concerned at the same time.
I would imagine legally it would be much harder and more lengthy to establish a trial caused unwanted outcomes if a person already had complex medical issues.
This begs another question: Are medical trials patient friendly?
In the case of the Northwick Hospital trial you link to, which was horrific, it was in the phase 1 trial when it went wrong, which uses healthy people, often staff linked with the companies involved with the drug. The animal testing takes place before and in this case there had been no problems, which is why they went ahead. The trials are usually farmed out to specialist companies. To get a drug on the market can costs on average nearly two billion dollars and takes around twelve years.
Yes I appreciate this trial was a phase I and done on healthy people. With regard to FMundo's point who takes responsibility when unintentional harm is caused, the point I was making was how much more difficult would it prove to be for patients (who would be in phases II or III in any event) to get justice and how long would that take.
I think it is very much how long is a piece of string. One person claiming may get damages pretty quickly, as drug companies don't want to spend time and money on legal cases, while cases such as Thalidamide, which had actually been launched onto the market, took a great deal longer.
People in Phase 3 trials may be in a terminal state already and are willing to go on a trial with the possibility it might work for them.
I participated in two trials to gain access to the drug that would otherwise be out of my reach financially, aboraterone and xtandi. In both trials I was assured of getting the drug and not a placebo. Although the xtandi trial was and is for a blind study for a second drug taken in conjunction with xtandi, to test if it lengthened the effectiveness xtandi.
I almost took part in a trial for TAK-700 which was a disaster for those who participated. In all trials so far I was assured of getting the drug and not a placebo. At this point I would not take part in any trial where I would not be sure of getting the drug.
I have to say that I am very skeptical as to the truth of what you say. Blind tests are, by definition, tests conducted so that NO ONE knows (including those people administering the drug and the placebo) who is getting the "drug being tested". The major objective of a "blind test" is to ELIMINATE what is known as the "placebo effect" which is the phenomena that people who "think" they are getting a drug actually feel that they improve.
I guess it is possible that the people who conducted the test may have told you at the beginning of the test that you were getting the legitimate drug (when they really didn't know in fact whether you were or weren't). They were essentially lying to you at that point... if it was a true "blind test."
Now you may actually have received the drug in question. But the point is, if you're dealing with people willing to lie initially . . . what confidence can you have with the veracity of what they have to say at the end of the test?
A "blind test" is termed blind for a reason. Participants and researchers are blind to the fact as to who is getting the real stuff.
FMundo I totally agree. A double blind trial is exactly that and the whole point is that people do not know whether they are taking a placebo or not. Of course after drug approval, phase 4 does a check on the long term effectiveness and use of the drug, also such things as comparison to other drugs, which is what Magnus may be talking about. The drug may then be taken off the market or have more limited use.
I cannot believe that the clinical trial company running the drug trials would lie as there is too much at stake, also they are normally specialist clinical trial companies not the original pharmaceutical company. The people working for those companies tend to be of the academic kind rather than the snake oil salesman variety.
I believe in the trial mentioned by Magnus1964 the first drug was given to all, it was the second drug that was blinded. This is pretty common you know you're getting the the first but not necessarily the second. Don't assume someone was lying, clinical trials are very costly and actions like that could risk the entire trial so very unlikely to happen. Not sure if you hold a negative opinion of clinical trials or not, but it appears you do.
As I read her article it appeared to me that blind applied to the test and not just an "add-on" drug to the test, which seems to be the case with a second reading, so I'll stand corrected on that.
As far as your conclusion that I am "negative" on Clinical Tests you are not correct. Not only have I participated in one, I consider them essential.
Because I rely on the results of Clinical Trials, I want to encourage participation by seeing that unfair financial and medical burdens are not put on the shoulders of people risking their health in participating as subjects in the trials. Some vehicle for support (such as insurance) should be developed. I don't think people should have to "sue" to be cared for.
... No, I haven't been harmed by participation in a Clinical Trial .
.. and "yes" I would pay more money in some fashion were such support considerations provided, along with everyone else.
I stand corrected. When I first decided to participate in clinical trials I researched everyone I was interested in before applying and was amazed at how many I was turned down by because they felt it could cause adverse effects, I have stage 4 cancer which will at some point end with my demise without effective treatment so maybe my perspective is somewhat different than yours, however I do agree that no one should have to sue to be cared for .
There are compensation guidelines issued by the ABPI and the ABHI. I am sure that nothing can be so perfect that a court case is never necessary, but at least this does cover some situations, when things go wrong.
Everyone's life is important . . . whether their life expectancy is one month or twenty years. That should (and from responses of C.T. providers, that appears to be the rule). What we're focused on here is the issue that CT's are morally bound, following the trial, to provide support to those people negatively effected by the trial.
Participant health by examination, questionaires, tests and videotapes all can provide input in ascertaining the "before" and "after" picture.
You miss read my response. I am indeed receiving a blind study mystery drug but it is being giving in conjunction "with" xtandi. I am assured that I am receiving the xtandi which is reducing my PSA.
In my case, I developed rapid onset cataracts a few months after I stopped taking and experimental drug in a phase II clinical trial. I had heard that some patients had experienced this, and a couple of months into the trial, I was given an addendum to the informed consent that stated that rapid onset cataracts were a known possible side effect. My insurance paid for cataract surgery, and I do not believe I could have gotten the drug company to pay, because I had signed off.
I just participated in a phase 3 trial that put me in hospital, feeling more ill than I've ever felt in my life. To make matters worse, I was unable to contact the trials team, their 24/7 hotline didn't work, so my local hospital (not the same one that was conducting the trial) had no idea how to treat me. The condition for which I joined the trial is chronic and not life threatening or life limiting, by the way. I have ongoing problems caused by the trial drug, so the question of how much support a participant should or does get is of great concern to me at the moment. Currently, the answer seems to be, precious little unfortunately.
I am wondering what country you folks are in (I notice one person reference 2 UK organizations). Here in the U.S. the ICF (Informed Consent Form) clearly states that you are not signing away any future rights to take legal action against a drug company for adverse effects. The drug company also takes responsibility for any adverse effects received from the study drug.
As I tell people all the time, you really are in a clinical trial whenever you take medications. Your physician knows what has happened to other people, but we all have differences, and any drug can cause and unwanted effect in certain cases. We see that in the way drugs can be removed from the marketplace years after approval, or restricted in it's application.
The right and necessity to sue, assuming one has the energy to do that is not the issue. The issue is that the industry standard should be that any damage caused by a trial should automatically and without hesitation be undone by indiviDuals or organizations running the trial. It's a moral issue. As a practical matter its a cost of doing business.
Cancer clinical trials are so highly regulated and there is a very in depth consent process. These days there are many laws in place to protect the patient. Placebo is not allowed in cancer trials at all and everyone by law must get a minimum of standard of care treatment. Because ct's are so closely monitored the participants usually get better and closer monitoring then they normally would. Most patients who participate in cancer trials have little to lose and a chance to extend their lives. I know firsthand from personal experience with my husband who was diagnosed with stage 4 pancreatic cancer at 44 and told he had a few months to live. It was because of his trial that my daughter remembers him. The trial didn't make him sick and extended his life by 19 months.
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Four years & 70 anti-PD-1 infusions on clinical trial
