Advancements in medicine need research to back them up prior to using the technology and medication on humans. The first phase for a clinical trial is essentially one that tests out the new treatment. This often involves an animal study or study in the lab in cells looking at the effect of the treatment. But it does not usually involve human testing.
For a study involving a medical device, for instance, the phase 1 study can be performed to make sure the device can safely be implanted, using animals and biomechanical testing in a lab.
Assuming the results of phase 1 are satisfactory, phase 2 is where the treatment is performed on humans. This can only occur if phase 1 shows relative safeness and a viable treatment method. Depending on the area of medicine where the treatment is being evaluated, the follow-up time periods will vary. For instance, a medical device for orthopedics may necessitate a one-year follow-up and sometimes even upwards of two years.
Any medical practice that has the resources, desire and patient base can participate in an FDA clinical trial. Typically, the sponsoring company for the study has ties to the practice, or the practice has a high volume of patients that are study candidates.
It is very important for the sponsoring company to keep very specific data on their human participants including follow-up visits, complications, reasons for a drop out, etc.
Once the phase 2 is completed and treatment is deemed to have passed the safety profile of phase 2, phase 3 is designed to truly measure the effectiveness of what’s being studied. It really is an extension of phase 2 but needs to have statistical significance to show the effectiveness in humans.
After phase 3, the data is submitted to the FDA for final evaluation. If the treatment is found to be effective in a statistically significant manner with a reasonable safety profile, FDA approval can be received.
It is at this point that the treatment can become instituted officially in clinics around the country and work towards achieving insurance coverage. Simply receiving FDA approval is no assurance of insurance coverage.
An example of this is lumbar artificial disc replacement. Even after tens of millions of dollars was put into a successful FDA clinical trial and the treatment was approved, a lot of insurance companies still denied patient treatment by saying that it was experimental. It is an excellent mechanism for insurance companies to hold off on paying for the treatment as long as possible. Especially considering that new technologies costs considerably more money.
When a treatment becomes FDA approved, it is approved for an indication which then is specified “On Label”. Frequently, treatments are used for additional purposes and then become an “Off Label” indication. Only about 30-40% of medicines put through an FDA trial actually pass all the way through.
An example of this is the way that Neurontin is often used for nerve pain by LA pain clinics. The original FDA approval for Neurontin was as an anti-seizure medication, not for nerve pain.
This is a general overview of how the FDA clinical trial process works. There are plenty of studies conducted outside of the FDA to look at the effectiveness of various treatments.
Los Angeles pain management doctors often participate in clinical research, whether or not it’s an FDA trial, to benefit patient care. The California Pain Network connects those in pain with pain management Los Angeles trusts. Call (310) 626-1526 for more information and scheduling.