Medicines and medical devices save lives. The items now found in pharmacies and hospitals everywhere began in laboratories and other research facilities. Clinical trials, carefully governed experiments involving human subjects aimed at determining the efficacy and safety of a newly developed medicine or piece of medical technology, are an important part of the research process. To be clear, we believe in this process, one that produces life-saving products. We also know that companies in both medical and pharmaceutical industries have, at times, cut corners in this lengthy and expensive process. When the failure to abide by the carefully crafted rules leads to clinical trial injuries, illness, or death, our Panama City medical malpractice lawyer is ready to hold the companies accountable and obtain monetary compensation for the victims.
A new clinical trial is underway and, as WJHG notes, Bay Medical Sacred Heart is one of the participating locations. The trial involves a heart stent that may help cardiac patients, a slinky-like tube that may open clogged arteries and temporarily help restore and maintain the flow of blood to the patient's heart. While normal stents stay in the body for life, the new Absorb device will biodegrade after two years. The clinical trial is set to involve 2,500 patients and more than 200 medical centers. Placebos are a standard part of the clinical trial process, and only about 1,000 of the patients will actually receive the new stent.
A set of pages authored by the National Heart, Lung, and Blood Institute provide a useful overview of the clinical trials concept/process. They note that clinical studies are one of the final steps in the long research process for new medical treatments, strategies, or devices, aimed at determining if the innovation is safe and effective in humans. Clinical studies must follow strict scientific standards in order to produce reliable results and protect the patients involved in the study. Each trial follows a master plan known as a protocol that lays out the process and the reason behind the plan. The protocol often address how to avoid letting bias impact the results. A large portion of trials use comparison groups, meaning one group gets the new treatment and others get an old treatment, or in cases where no standard treatment is known, a placebo.
In order to protect patients and ensure ethical research, institutional review boards provide independent oversight of each trial. Additional oversight is provided by the Office for Human Research Protections, Data Safety Monitoring Boards, and the Food and Drug Administration. Another important safeguard is the requirement that the study obtain the informed consent of the subjects.
Clinical trials have helped produce life-saving medical interventions. However, sometimes something goes wrong. If someone is injured or killed, questions must be asked. Was the study negligently conducted? Did it meet all legal and ethical requirements? Was the protocol followed precisely? Did the victim truly receive all the information needed to make consent meaningful?
If you or a loved one was injured in a clinical trial, you may have a civil claim. Our Panama City clinical trial lawyer understands the wide range of claims that may apply when the improper conduct of a trial leads to injury, illness, or death. Call to schedule a free consultation.