Did you know that clinical trials help medicine move forward? Without them, we would miss out on new procedures, medications, new medical devices, more effective ways to diagnose disease, and other advances. Clinical trials are a way to prove new forms of treatments have value towards patient care. Some people participate in clinical trials because, even though they are healthy, they want to give back. Others have a certain disorder and might benefit from treatment. Below are some things you should understand and consider before participating in a clinical trial.
What Happens in a Clinical Trial?
Clinical trials are a form of medical research. After what may be years or even decades of laboratory work, which often involves animal studies, promising research is then greenlighted to start testing the effectiveness of a given experimental treatment or diagnostic procedure on humans. A protocol (clinical plan) is developed that lays out the groundwork of how the testing will be done, who can or cannot participate (age, weight, patients with or without a certain disorder or condition), what they are seeking to prove, how the information will be gathered and tracked, as well as how long the study will take.
While every precaution is taken to ensure trial participant is safe, by its very nature, clinical trials include some inherent risk. That is why the law requires what is known as informed consent. Basically, it means that the researchers creating the study must explain any relevant facts and potential risks to anyone who is going to participate. This is not a one-time requirement either, as informed consent is required throughout the clinical study. Researchers have to explain what will be done, any potential benefits and risk, where and how research will be conducted, and how long the participants can expect the trial to run.
Medical personnel monitor trial participants and gather feedback about any responses, unexpected reactions, and the health of those in the trial. In the US, most trials are monitored and reviewed by the Institutional Review Board (IRB). The IRB helps to create and enforce any rules and guidelines to ensure that the trials are conducted ethically and that the individual rights of clinical trial participants are protected. Before participating in a clinical study, consider this information carefully and make sure that the research is approved and monitored by the IRB.
Clinical trials are completed in phases, with different facets and research goals. There are also different kinds of clinical trials. These include: quality of life trails, screening trials, treatment trials, prevention trials, and diagnostic trials. If you would like to know more about participating in a clinical trial, or to make an appointment with one of our outstanding orthopedic physicians, please call Tucson Orthopaedic Institute, in East Tucson at (520) 784-6200, Northwest Tucson at (520) 382-8200, or Oro Valley at (520) 544-9700, or request an appointment online.