VOLUNTEERING FOR CLINICAL RESEARCH STUDIES

Clinical research studies are vital to improving the quality of care for those with chronic conditions. Patients who volunteer at AMCRI contribute to the discovery of new therapies to treat and possibly cure their illness. You are an important link to cutting-edge research that can benefit people long before a medication or device becomes available in the healthcare marketplace.

Each study has specific requirements such as age, sex, and a current diagnosis of the medical condition under study. A physician reviews the medical history of anyone interested in participating All volunteers will be given details on the study procedures, risks and benefits as part of the required informed consent process. This process allows volunteers to ask pertinent questions of the clinical study team and to be regularly informed about all aspects of the study they are involved with.

WHAT IS CLINICAL TRIAL?

• Clinical trials are conducted to answer a specific question
• Scientists perform clinical trials on patient volunteers in an effort to discover innovative methods of patient care and to improve those already in existence
• In the United States, clinical trials are conducted under the direction of FDA (Food and Drug Administration) before being made available for general clinical use
• Clinical trials are not to be confused with treatment

WHY PARTICIPATE IN A CLINICAL TRIAL AT AMCR INSTITUTE?

• Help people suffering from diabetes, obesity and other endocrine disorders
• Gain access to investigational treatments before they become widely available
• Play a role in the discovery of treatments, and a more active role in your own healthcare
• Obtain access to free physical examinations and diagnostic tests related to the study
• Be compensated for time and travel related to the study

CLINICAL TRIALS AND TYPE 2 DIABETES: INSIGHTS FROM DR. STEVEN EDELMAN

Clinical research studies are vital to improving the quality of care for those with chronic conditions. Patients who volunteer at AMCRI contribute to the discovery of new therapies to treat and possibly cure their illness. You are an important link to cutting-edge research that can benefit people long before a medication or device becomes available in the healthcare marketplace.

A typical study evaluating a drug for people with type 2 diabetes will involve a placebo, or dummy pill, as well as the actual drug. These types of studies are referred to as double blinded. The research subjects, the investigators, and the nursing staff do not know which (the drug or the placebo) was given to each study participant. This eliminates any potential bias and makes the data more meaningful.

Before any clinic or institution starts a clinical trial, an official independent body called the Human Subjects Committee evaluates the study for safety based on early animal and human laboratory studies. Typically, these are done well before the large studies that you hear about. These committees and boards are very strict and will not allow any further study to be performed without the proper precautions in place and prior data showing its safety. In addition to that, each study has an External Data Safety Monitoring Board that has access to the data as the study proceeds and they have the authority to stop any clinical trial if they see a safety problem. They can also stop a study if the results are so positive that it is just a waste of time to delay the findings. The entire process is extremely meticulous, decisions are made very carefully, and there is an enormous amount of detailed data analysis.

What's in it for you?

Well...what's in it for you? Research advances our knowledge of medicine and the potential to have superior drugs and devices for people with type 1 and type 2 diabetes. There are also many personal benefits when it comes to getting involved.

1. You typically get a free, full history and physical exam as well as an executive type of laboratory workup including: a chemistry panel, lipids, AlC, complete blood count, electrocardiogram, chest X-ray, etc;
2. Very often you will receive glucose testing supplies if it pertains to the study and access to caregivers who know a lot about diabetes.
3. Most studies will pay you a stipend for your time and travel expenses.
4. If you do not have health insurance or good coverage with a large donut hole (I love donut holes; especially the ones with the sprinkles)
5. Getting involved in a clinical study is really awesome.

Often times people improve their AlC merely from the attention they get from the clinical research staff, even the placebo group.

What is the down side of getting involved in a study?

1. It is time consuming, especially in the beginning. However, you are paid for every visit and the number of visits typically go down over the duration of the trial.
2. You will need to get your blood drawn in the beginning, at the end, and sometimes in the middle of a typical study.
3. You may be randomized to taking the placebo and not get the potential benefit of the drug being tested. If this happens you probably will not improve as much as the folks taking the drug being tested. However, if for some reason your diabetes control worsens, there are rescue protocols in place that will switch you over to the active, or real drug, or allow you to exit the study. There is also a human subjects bill of rights that allows you to withdraw from any study at any time. All of this is explained to you up front before, signing up to be a research volunteer.

Now is an excellent time to be a research volunteer. I have been doing clinical research for over 20 years and I have seen so many positive things come out of the research, including advancement in oral medications, designer insulins, devices such as pumps, CGM and HGM, and many grateful subjects. It comes down to being educated about the study, asking questions, showing it to your own provider first, if desired, and weighing the pros and cons of getting involved.