Clinical Trial Injuries & Lawsuits

Ohio Lawsuits & Legal Rescources

Clinical trials or clinical studies test potentially new treatments. The new treatment could be a pharmaceutical drug, medical device, vaccine, blood product, or gene therapy. Before testing on humans, these treatments must first be studied and tested in laboratory animals to determine their toxicity. Treatments that show the most promise in lab animals advance to human clinical trials.

It's important to remember that clinical trials are just that - drugs or treatments that have not been approved by the Food & Drug Administration and are still in the testing stage. Essentially, people have replaced the laboratory animals to test the safety, effectiveness, and toxicity of the drug or treatment.

If you or a family member has been injured because of participation in a clinical trial, find out what your legal rights are.

What are the risks associated with clinical trials?

The FDA tries to protect persons who participate in clinical trials but the FDA does not develop new therapies nor does it conduct clinical trials to demonstrate safety and effectiveness. FDA staff members meet with researchers, and perform inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data.

Before participating, persons are asked to read, understand, and sign an informed consent document demonstrating that they know what they are doing; that they know what the risks are; and they can leave the clinical trial whenever they want to or that the clinical trial may exclude them at any time.

Risks include unpleasant, serious, and/or life-threatening side effects and/or death.

Sometimes side effects go away when the treatment is over; sometimes they are permanent. Sometimes the side effects don't show up until the clinical trial is over.

Other risks are ineffective treatment; the protocol may be too time-consuming especially when subjected to additional testing; more treatments than necessary; unexpected hospital stays; or complex dosing required.

All known risks must be fully explained to the participants by the researchers before the trial begins. If new risk information becomes available during the trial, participants must be immediately informed.

You should know that circumstances may terminate you from the clinical trial. Researchers may do so without your consent. Participants may also be terminated if toxic side effects or sudden kidney problems develop.

If you or a family member has been injured because of participation in a clinical trial, find out what your legal rights are.

Sometimes clinical trials offer hope. Sometimes clinical trials are hopeless failures.