Issue 33.15
Have you ever wondered how a prescription drug, non-prescription or devices makes it to the market? Well, the U.S. Food and Drug Administration (FDA), through many, many years of research they have come up with a well-orchestrated process for the makers of drugs to follow.
Drug companies develop many new drugs in a very systemic process. Due to the years of research we know a great deal about multiple diseases and with technology advancement they can use computer modeling to design the drugs to work in specific ways. If the company is trying to develop drugs to help diabetes, they can design the drugs that will, at least theoretically, work directly where the scientists and doctors want them to. An example of this is in the case of diabetes. Multiple new drugs are in the pipeline but one specific class is currently being looked at which are identified as “GLP-1 receptor agonists”. These types of drugs enhance glucose-dependent insulin secretion following its release into the circulation from the gut and enhance glucose-dependent insulin secretion by the pancreatic beta-cell, suppress inappropriately elevated glucagon secretion, and slow gastric emptying.
A lot of times it is just plain luck that leads to these discoveries. A drug may be studied for one therapeutic area and is found to make a significant difference in another therapeutic area.
When a drug is identified and purified, it is tested in animals. This is done to show the scientists the drug does or does not perform the way we think and if it is safe. This is a controversial issue but at the moment it is essential, because as good as our understanding of disease is, there are always surprises. Testing in living systems such as animals or humans can give the definitive answers.
Once the drug is shown to work and demonstrates if is safe in the animal testing trials the drug company will then apply to the FDA for approval for testing in humans.
If FDA approves, the drug company will begin testing the drug on humans under very strict, structured, specific phases and each phase is designed to answer different questions. There are 4 phases to this process.
Phase 1: helps define the dose of the new drug and its negative effects and this phase involves a small group of volunteers to ensure the safety of the drug and is the first time in humans.
Phase 2: helps further define the safety and effectiveness of the new drug in a larger volunteer group with the disease or disorder the drug is being looked at.
Phase 3: designed to show the drug works as intended, low incidence of negative effects and is safe. This is a larger group of volunteers and usually compares the drug’s effectiveness to that of other treatments already being used.
Phase 4: this phase is post-marketing for a drug already approved by the FDA but the drug company continues to monitor the long term use for effects of the drug and any new side effects.
Only a small amount of drugs actually make it to thru the final process and make it to New Drug Application and approval by the FDA. This process from discovery to a new drug can take decades and millions of dollars.
In a nutshell, this is how drugs are and devices are brought to the market and without a couple of thousand research subjects and under very controlled settings can this be accomplished.
Our area is fortunate to have several physicians working as researchers and conducting multiple trials for various therapeutic areas to bring new drugs and or devices to the market.
Chrysalis Clinical Research is currently enrolling trials for Type 2 diabetes, constipation, asthma and coming soon strep throat (ages 12 to 17) shingles and arthritis of the knee.
For more information or see if you might qualify for a clinical trial and help us bring new innovative drugs/devices to market contact Chrysalis Clinical Research at 435 656 1704 or visit our webpage www: sgccr.com.