Most patients visiting a hospital or a doctor know that if the improper standard of care is applied by any medical professional and the patient is injured that the victim may be entitled to pursue a claim of medical malpractice. The situation involving clinical trials, however, is somewhat different. Read on to learn more about how clinical trials work and what to do if you or a loved one is injured in one.

Basics of Clinical Trials

It’s estimated that at least 19 million people participate in private and public clinical research trials every single year. These clinical trials are used to evaluate whether or not a new treatment, drug, or device is effective as well as safe for use with humans. Typically, a clinical trial will occur after the animal testing phase.

When a company is ready to take their testing to the human level in the U.S., they have to receive approval via an investigational new drug authorization from the FDA. Although timelines may vary, a clinical trial can go forward as soon as 30 days after filing the IND. The FDA reviews the IND but can also halt a trial at any process in the event that problems emerge.

Clinical Holds

Clinical trials are responsible for following clear protocols with well-outlined standards. Clinical trials usually also have to report any “serious adverse events” to their review board. If patients are injured or killed during the trial, research managers also need to respond to these issues as quickly as possible to determine the cause of the problem and even put the trial on hold, if necessary.

When a hold happens, whether voluntary or from the FDA, researchers will typically stop all experimental treatments . Holds are very rare, but with a median length of eight months, they can present concerns for research managers and patients alike. In a recent case involving an aggressive CART therapy clinical trial for adult leukemia managed by Juno Therapeutics, however, the clinical hold placed after a few patients died from cerebral edema was lifted just a few days later.

Several months beyond that, more patients died in that clinical trial with similar symptoms. This has raised numerous legal questions for family members of the victims who passed away. Experts in the field are even asking whether or not the FDA did enough in this instance.

Be aware that even though informed consent documents are typically signed in advance of a clinical trial, family members of a lost loved one may still be able to pursue a legal claim if negligence or reckless behavior was the cause of their loved one’s injuries. It becomes all the more important to engage the right lawyer in this situation given the complexities of the law surrounding clinical trials. If you or someone you know has been hurt in a clinical trial and you have questions about your next steps, don’t wait to reach out for the help you need. A lawyer can help you understand your rights and responsibilities.

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