Diabetes Clinical Trials are crucial to the development of new, cutting-edge drugs and therapies. Clinical trials must be conducted to view any side effects and to gauge the positive effectiveness of any new drug and the United States Food and Drug Administration (FDA) will not approve any drugs that have not gone through these carefully conducted programs.
Stages of clinical research trials involves four basic phases, each designed to gain valuable information about the specific drug being studied:
Phase One: involves a small number of human volunteers and this stage is to determine the best dose for patients and to take note of any side effects. This stage possesses the highest risk for participants.
Phase Two: Once the drug is proven to be safe with no major side effects; it moves on to this stage which involves a large number of volunteers to see how well the treatment or drug works.
Phase Three: Randomly, in this phase, the new drug will be compared to treatments that are already on the market. This stage can use thousands of volunteers; and will pose less of a risk than phase one.
Phase Four: This phase is conducted after the FDA has approved the treatment and it is now on the market for the general public. This stage of study is designed to find alternative uses for current therapies and also to look for any added side effects that were not observed in the previous phases.
Why would someone take part in a clinical trial?
There are a variety of reasons that people would take part in this type of research; one of which is that some patients are not responding well to standard or current drug therapies and they are looking for new, up to the minute treatments. While others just want to help the science of useful medicine move along and help researchers and doctors find an alternative method of treatments and possibly moving in the direction of making diabetes a disease of the past.
All participants are closely monitored through testing and exams to insure their safety.
Because these are drugs and treatments that are still in the “testing” stage; it is important to know how you will be protected if you choose to be involved
Clinical research is focused on two things; one being the focus of the study and producing accurate results and the other is maintaining the well-being and health of those participants. There are strict principles and guidelines to follow (both scientifically and ethically).
A protocol is drawn up, usually by the study doctor, which outlines exactly what will be done during the study. This written protocol is reviewed and must be approved by those sponsoring the study and also by the Institutional Review Board, whose job is the make sure that study participants are not exposed to unreasonable risks.
There are new types of developments for patients with type 1 and type 2 Diabetes; such as gene therapy, islet transplants (a possible cure for Type 1 Diabetes), and inhaled insulin.Current research is also focused on who is at risk, preventing type 2 diabetes and to predict the onset of this disease. Continuous glucose monitors are currently available; but researchers are envisioning a product the will combine these special glucose monitors with an insulin pump.
But before these new types of treatments can be made available to diabetes patients and to improve their quality of life; they must be rigorously and formally tested through Diabetes Clinical trials.