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?
I think it depends very much on the contract you sign and the law of the land.
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.
c
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.
Firstly I am sorry you have Parkinsons Frank.
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.
thepsychologist.bps.org.uk/...
The link has nothing to do with the delphi I am involved with.
Regards cx