By volunteering for a diabetes clinical trial, you play a crucial role in advancing our understanding of human diseases and developing innovative treatments. Your participation grants you early access to potentially life-changing therapies and contributes to the global health community by sharing valuable information from your experience.
The Clinical Research Center at Texas Diabetes Institute, with its 25-year history of conducting studies, has been instrumental in developing many leading diabetes treatments, and your involvement could be the next step in this journey.
Let's address some common misconceptions that may be preventing you from considering participation in a diabetes clinical trial. We want to ensure you have accurate information to make an informed decision.
Myth: “I’ll be a guinea pig.”
Truth: It's a common misconception that participating in a clinical trial means being a "guinea pig."
Clinical trials are conducted with the highest scientific rigor, following strict criteria for selecting participants, tests that will be used, and the safety of data collection.
Before starting, clinical trials undergo a rigorous review by the Internal Review Board (IRB) from the academic institution, clinic or hospital where the research study will be conducted. The IRB follows standard practices, as described in the Good Clinical Practice (GCP) Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S.
Myth: “Participating in a diabetes clinical trial won't cure my disease.”
Truth: Engaging in a clinical trial might not lead to a direct cure for diabetes or offer immediate benefits, but it can be a significant way to:
- Contribute to innovations in diabetes and medical research
- Provide beneficial insights into new treatments
- Improve diabetes management
- Reduce your risk of complications
- Help others facing similar challenges in the future
Myth: “I need permission or a referral from my doctor to participate in a clinical trial.”
Truth: We value open communication with your primary care team, but you are not required to have a referral from them to join a clinical trial.
Before enrollment, you will undergo a screening process to ensure you meet the study's entry criteria and to minimize any associated risks. Participating in a trial can provide you with early access to specialized therapies and testing that may not yet be available through your health care provider.
Myth: “If my doctor refers me to a clinical trial but I decide not to participate, this will harm my relationship with or the care provided by my doctor.”
Truth: If your doctor believes you are a good candidate for participation in a trial, it does not necessarily mean you are the best fit for the study. You have the right to decline involvement in any study since participation is strictly voluntary.
Furthermore, suppose you enroll in a clinical study and stop participating, there will be no penalties, and you will still be eligible to be considered for future studies.
Participating in a clinical trial will not affect your care because you will receive, at the least, the standard of care for the conditions being investigated.
Myth: “You never know what they are doing to you or who can see the results or find out you are doing a study.”
Truth: The data collected from you is anonymized before being used for statistical analysis and published in scientific journals. It is only used for research purposes or protected under proprietary information confidentiality agreements during drug development.
In most cases, tracing the data back to you as an individual is very difficult. The Health Insurance Portability and Accountability Act (HIPAA) protects participant data from clinical trials, and only authorized entities and selected individuals will have access to data that can identify you solely for data analysis or to ensure that the procedures are carried out safely and as intended. These entities and individuals are listed in the consent form you review before agreeing to participate.
Study participants are always informed about the general course of the study and any new information that may be clinically relevant to their general care.
Myth: “I must pay to be in a clinical trial.”
Truth: You will not be charged to participate in a clinical trial.
Indeed, most of the clinical trials compensate for the time you spent as a volunteer coming to the visits and participating in the research tests. However, tests conducted during the study that become strictly necessary to provide standard medical care and are not part of the research protocol may incur costs.
Diabetes Clinical Trials at Texas Diabetes Institute
If you are interested in participating in one of our clinical trials, please call the Texas Diabetes Institute Research Center at 210-358-7200 or access a list of our active research studies.
