Some of us have participated in clinical trials desisned to test the safety and/or validity of a new medical treatment. We often fail to appreciate fully the possible dangers involved and their consequences.
For example - who is responsible financially (especially for any increased medical treatment costs) if something does go wrong and leaves the patient with more problems than they had before commencing the trial.
Federal law does not require researchers to compensate participants harmed in such trials. It merely requires that their consent forms spell out whether compensation will be available for research-related injuries in trials that involve more than minimal risk.
Health care providers, drug makers and insurance companies do not want to end up paying for all of somebody's care especially when parts of that care might have already been needed because of some pre-existing condition. Proving that additional harm has been done, what caused it and who or what is responsible can be difficult and in many cases unresolved disputes result in lawsuits.
This issue has come into heavier focus as drug companies, under increasing financial pressure to bring drugs to market, have stepped up the pace of 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, a clinical-trial listing service. The growth has come in part from a jump in small early-stage trials meant to help drug companies weed out duds quickly. Makers say it is also increasingly common to test a single drug multiple times to see if it can treat different conditions.
There is little definitive data on the number of injuries from clinical trials, partly because there is no one government body that regulates all of them. But the issue is getting more attention following several widely publicized lawsuits.
Many lawyers had long been reluctant to pursue clinical-trial injury cases because they worried that the required consent forms might protect the drug companies and universities from any liability. Still, cases have been brought to trial or otherwise settled and the publicity surrounding these cases has helped raise public awareness of safety issues with clinical trials. The successful prosacution of these lawsuits also shows that it is sometimes possible to find flaws in the wording of the informed-consent agreements between the parties involved in these clinical-trial injury cases.