Just what can happen when a clinical trial goes awry and a participant is hurt? Take the example of Suzanne Davenport.The Wall Street Journal chronicles how she entered a trial testing a drug for Parkinson's disease - before the trial, she could drive, cook and care for herself. Within months, she was in a wheelchair in a nursing home. Her family says the trial caused her precipitous decline and, faced with growing medical bills, filed a lawsuit againt the two drugmakers that ran the trial and the university that enrolled her in the trial.
The case highlights one aspect of the legal and regulatory void surrounding clinical trials, the Journal points out. That's because federal law doesn't require researchers to compensate participants harmed in trials - they're only required on their consent forms to spell out whether compensation will be available for research-related injuries in trials that involve more than minimal risk.
The prospect of compensation for injuries can encourage volunteers who might otherwise be reluctant, the paper continues, but adds that wording in consent forms can be confusing or vague. For instance, it may be unclear which research entity is responsible for the cost of subsequent care, how much that entity will pay and under what circumstances it is obligated to pay, the Journal writes.
One big problem is that it can be difficult to separate what was caused directly by a trial from the natural progression of a participant's disease. Drugmakers "do not want to end up paying for all of somebody's care when that care may simply be the product of the fact that that person had a grave illness," Haavi Morreim, a University of Tennessee bioethics professor who has studied clinical-trials lawsuits, tells the Journal. We raised this issue recently concerning omissions in consent forms for Merck's Vioxx trials, which you can read about here.
The issue is gaining attention as drugmakers face increasing financial pressure to develop new meds and so are conducting more clinical trials. World-wide, the number of industry trials rose to 59,000 in 2006 from 40,000 in 2000, according to an estimate from CenterWatch, the Journal writes.
You can read the rest of the story here, but a subscription may be required. [Make sure to take a look at the documents. For instance, there are links to the university consent form signed by Davenport; the contract between the university and the drugmaker; the consent form prior to her surgery, and a series of exchanges between her daughter, the drugmaker and the family attorney.]