What is a Clinical Trial?
When an inventor comes up with a new idea for a medical device or treatment, the medical community and the U.S. Food and Drug Administration (FDA) are initially skeptical about recommending the innovation for medical practice. Oversight is critical to making sure that an innovation about diagnosis or treatment is safe and effective. To convince the medical community (and the FDA) that your new idea has merit requires that you do clinical trials.
Clinical trials are usually performed in association with medical schools and are considered research. Clinical trials involve recruiting volunteer patients to use the new medical device or treatment. The volunteers must be told that the medical device or treatment is unproven or “experimental”. The volunteers must agree to participate knowing that the medical device or treatment may not be effective. All volunteers must be given the opportunity to stop participating in a clinical trial if they become uncomfortable with the clinical trial process for any reason. Lastly, the volunteers are told that the information from their trial participation may not be made public until the trial is completed. Clinical trials always use a concept called the “Null Hypothesis”. The “Null Hypothesis” means that the researchers must assume the device or treatment does not work. The trial is only considered successful if the data from the trial disproves the “Null Hypothesis” and shows that the device or treatment actually worked as intended.
There is a concept called the “Standard of Care” which providers use to diagnose and treat diseases. The “Standard of Care” is loosely defined as what a trained and licensed practitioner would order (to diagnose) or prescribe (as treatment) for the same or a similar illness. The “Standard of Care” evolves over time, as new and better options become available to providers. The “Standard of Care” permeates all of medicine, as it is taught in medical schools, practiced by providers, and reviewed by peers if the diagnosis or treatment is ineffective. In order for a new device or treatment to become part of the “Standard of Care”, the researchers must convince medical providers and the FDA that the new invention has merit based on successful clinical trials.
If you have ever volunteered for a clinical trial, you helped advance medicine whether the device or treatment actually worked. Many past volunteers become aware of the trial’s success or failure by watching the media years after they participated. If the device you tested becomes available to other patients, your participation in the trial made that possible. If you were in a treatment trial and the treatment is now available to other patients, your involvement helped medical providers accept that treatment as part of the “Standard of Care”. EMF Disturbance Monitors will begin our first clinical trials next year to determine if our patented technology can diagnose heart disease. Follow us along on that journey as we try to advance medicine.
