Liability Risks Hamper Clinical Trials: Coherent, dependable scheme is needed to protect all participants.

CLINICAL TRIALS, the testing of new medical treatments on humans, are often spoken of as an important source of new treatments for disease, but they are also an important alternative source of healthcare for many thousands of patients.

Many illnesses have approved treatments that are of little or no benefit at all. Other illnesses may have robust treatment regimens, but such treatments may not be effective for a large cross section of patients. In other cases, a treatment may exist, but the cost may be prohibitive for many patients or their insurance or Medicare or Medicaid may not cover it.

For any of these patients, enrollment in a clinical trial may provide the possibility of receiving either customary care for their illness, referred to as “standard of care” treatment, or a possible new treatment or, in some cases, a combination of both.

Participation in clinical trials always carries some risk to the patient’s health. While rare, in some cases administration of a new treatment regimen, drug or biologic or use of an investigational device may even result in injury or death.

Disclosure of known potential risks is made to potential trial participants through the informed consent process, resulting in execution of a form that has been reviewed and approved by an institutional review board or, outside the United States, an ethics committee, a group formed to review the trial and protect the rights and health of the trial participants.

While the current clinical trial scheme in the United States requires sponsors of trials to provide potential participants disclosure as to known potential risks of participating, there is no coherent and dependable scheme in this country for the protection of patients, hospitals and sponsors against the costs posed by clinical trial injury.

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