What is a clinical trial?
A clinical trial is scientific research involving people that studies the effects of a new medication, therapy or device to determine if it is safe and effective.
In the United States, clinical trials are monitored by the Food and Drug Administration.
The Phases of a Clinical Trial:
Phase I evaluates dosage parameters.
Phase II continues to evaluate safety and begins to study efficacy.
Phase III compares the new drug with standards of care or if there are none, a placebo.
Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.
Diabetes clinical trials may involve studies of prevention of diabetes or the treatment of diabetes.
Types of Diabetes Clinical Trials
- Action studies (doing something) – These focus on finding out whether actions people take, such as exercising more or quitting smoking, can prevent diabetes or their impact on current diabetics.
- Agent studies (taking something) – These studies examine whether taking certain medicines, vitamins or food supplements (or a combination) have an affect on preventing or treating diabetes.
Why Participate in a Clinical Trial?
People participate in clinical trials for many reasons including the opportunity to try new cutting edge therapies under the care of leading researchers and health care providers, and for the opportunity to contribute to research to help themselves and others.
Clinical trials do have side effects including the possible negative effect of the therapies and/or no effects at all and they can be more time consuming than originally anticipated.
If you are considering participating in a clinical trial not only is it important to explore all facets of the trials through informed consent, but it is important to determine the cost and funding of a clinical trial and how your insurance coverage or Medicare comes into play. While often the medication being tested is free, there may be additional costs such as lab tests and hospitalization which are not.
Get answers ahead of time.
In depth resources on clinical trials and registries for clinical trials:
World Health Organization International Clinical Trials Registry Platform. “The mission of the WHO Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.”
CRISP, Computer Retrieval of Information on Scientific Projects. “A biomedical database system containing information on research projects and programs supported by the Dept. of Health and Human Services.”
Center Watch: Clinical Trials Listing Service. This site provides a notification services for new clinical trials.
American Diabetes Association provides basic information on clinical trials.
Juvenile Diabetes Research Foundation International lists current JDRF funded clinical studies and provides information on what phase those studies are currently in.
The Children With Diabetes site lists current clinical trials.
Diabetic Clinical Trials in the News:
- The TODAY Study. (Treatment Options for Type 2 Diabetes in Adolescents and Youth) “The purpose of this trial is to examine the safety and effectiveness of three different treatments for type 2 diabetes in the pediatric population. The TODAY trial is being conducted at 12 medical centers around the United States. ” The is an open trial that is actively recruiting participants.
- TrialNet. “TrialNet is a network of 18 Clinical Centers working in cooperation with screening sites throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Australia, and New Zealand. This network is dedicated to the study, prevention, and early treatment of type 1 diabetes. ” TrialNet has many clinical trials going on in various stages. The newest studies, which are recruiting participants, are the Diabetes Interventions Study and the Natural History Study, and The Oral Insulin Study.
- Closing The Loop in Type 1 Diabetes. Currently recruiting for this study at Mass. General Hospital. ” Researchers at the MGH Diabetes Research Center are recruiting subjects to test an Automated Closed-Loop Glucose Control System for Type I Diabetics.”
Applying The Evidence: Clinical Trials in Diabetes by Anthony Barnett. (2005)
“Forefront, the American Diabetes Association’s research magazine featuring profiles of cutting-edge ADA-funded research currently taking place throughout the nation.”