Who pays for bad outcomes with Clinical Trials?

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?

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4 Replies

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  • 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.

  • Interesting questions FMundo.

    2 takes on the the same trial

    bbc.co.uk/news/health-22556736

    leighday.co.uk/Blog/April-2...

    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?

    cx

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