If you’ve ever wanted to be in a clinical trial or you’ve just been curious about the process, here’s some insight into how it all works.
In order for pharmaceutical and device companies to get their products approved by the Food and Drug Administration (FDA), they have to perform clinical trials with hundreds (often thousands) of people at research sites across the United States and around the world.
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 on a regular basis 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 important to get the medications being studied or device on the market as soon as possible to help others. The entire process is extremely meticulous, decisions are made very carefully, and there is an enormous amount of detailed data analysis.
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:
- You typically get a free, full history and physical exam as well as an executive type of laboratory workup including a chemistry panel, lipids, A1c, complete blood count, electrocardiogram, chest X-ray, etc.
- Very often you will receive glucose testing supplies if it pertains to the study, and access to caregivers who know a lot about diabetes.
- Most studies will pay you a stipend for your time and travel expenses.
- 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) getting involved in a clinical study is really awesome.
- Oftentimes people improve their A1c merely from the attention they get from the clinical research staff, even the placebo group.
What is the downside of getting involved in a study?
- It is time-consuming, especially in the beginning. However, you are paid for every visit, and the number of visits typically goes down over the duration of the trial.
- You will need to get your blood drawn in the beginning, at the end, and sometimes in the middle of a typical study.
- 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 upfront before signing up to be a research volunteer.
To find out what studies are recruiting throughout the United States and around the world, visit: clinicaltrials.gov.
If you’d like to sign up for the TCOYD/Behavioral Diabetes Institute Research Registry, click here.
Now is an excellent time to be a research volunteer. I have been doing clinical research for over 30 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, CGMs, and many grateful subjects. It comes down to being educated about the study, asking questions, showing it to your provider first (if desired), and weighing the pros and cons of getting involved. It is not guinea pig research anymore.
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