From Consent to Cure: Navigating the Steps of Clinical Trial Participation

Thinking about joining a clinical trial? Before jumping in, it’s worth slowing down and asking yourself some big-picture questions about your “why,” your comfort level, and what the process actually looks like. This guide breaks it all down: how to search smart, what screening and consent really mean, and what to expect once you’re in a study. Check it out, and decide whether participating feels right for you!

Step 0: Start by asking yourself the BIG questions. 

1. What’s your “WHY”?

• Do you want to find a cure? 
• Have you or someone you know been affected by the topic of the clinical trial and want to help? 
• Do you want to be part of the science that changes medicine? 
• Do you want to try new medicines that are not available yet? 
• Side hustle $$?

2. What phase of clinical trials am I comfortable with?

• Phase 1: First in-human studies to determine early efficacy and early results in healthy volunteers
• Phase 2: Focusing on a specific patient demographic and group (such as teens with type 1 diabetes)
• Phase 3: Larger studies to compare the effectiveness to the standards of care or placebo (substance or procedure given in place of an active treatment) 
• Phase 4: Studies after FDA approval to ensure safety and effectiveness in the “real world.”

3. Risks vs. Rewards

• What are the potential side effects? 
• Do I have the time to commit to frequent appointments and lab draws? 
• Am I okay not knowing if I get placebo or medication?
• How will my participation potentially benefit me and others?

Step 1: Find [Don’t Just Google, Search Smart!] 

Search reputable sites like National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Breakthrough T1D; ClinicalTrials.gov; or major medical centers like the UHealth Diabetes Research Institute (DRI) or Barbara Davis Center (BDC) to identify different ongoing clinical trials that you fit the inclusion criteria for (who they are looking for). Ensure that you do not have any exclusion criteria (reasons you would not qualify) and always verify with your healthcare provider prior to joining a clinical trial. 

You can also reach out to your healthcare provider to see if they know of any open studies! 

Step 2: Screening 

Once you have found a study and connected with the study coordinator, they will begin screening you for the trial. They will ensure that you fall within the inclusion criteria (what they are looking for i.e., T1D using a CGM or T2D on GLP-1 therapy) as well as exclude you if you have any exclusion criteria (what they are NOT looking for i.e., using glucometer instead of CGM or on Metfomin instead of GLP-1). 

The screening phase may include a series of interviews, labs, or exams. The researchers want to make sure that you are as good a fit as you think you are. 

Step 3: Consent = Know Your Stuff: 

While the informed consent process should answer all your questions, make sure to read through it and ask any lingering questions not answered! 

The consent should explain the following:  

• The purpose of the study
• Potential risks and benefits
• What to expect (labs, procedures, visits)
• Length of study
• That you can withdraw from the study at any point – no questions asked

Step 4: Participate

Here’s the trade-off:

1. Pros: cutting edge therapies at no cost, help advance knowledge and improve future of diabetes care 
2. Cons: new medications or therapies that do not have known side effects; potential of receiving placebo

Different ethnicities and minorities may react differently to a new medication or therapy, which is why diversity in trials is so important. Did you know that only 2-16% of clinical trial participants are racial and ethnic minorities, while racial and ethnic minorities actually make up to 39% of the US population? [1] With more diversity, you achieve better science that is more understanding and inclusive of everyone’s needs. It is important to note that the Lancet documented that 53 drugs approved in 2020 by the U.S. Food and Drug Administration (FDA) were tested in trials in which 75% of participants were White [2].  

Step 5: Follow-Up

After the study, researchers may follow up with you for months after or even a year after to see how you are doing and continue to assess the efficacy of the study and novel medication or treatment. Any type of follow up will be brought to your attention during the informed consent.

Step 6: Your Impact

All the medicine we have today once started in a clinical trial. If it were not for the brave people with diabetes (LIKE YOU) that wanted to be a part of changing medicine for the better, we would not have many of the medical advancements and treatments that we have today! Participating in medical research makes you an advocate in the diabetes community (which is something to be proud of!). Your participation can enable change and help not only make diabetes more manageable, but also bring us one step closer to a cure. 

References:

National Academies of Sciences, Engineering, and Medicine. (2024, November). Toward a Framework to Improve Diversity and Inclusion in Clinical Trials: Proceedings of a workshop. The National Academies Press. https://nap.nationalacademies.org/resource/28587/interactive/

Janet Brown-Friday; Diversity in Clinical Trials: A Complicated Issue, Not a Simple Solution. Diabetes Spectr 15 May 2024; 37 (2): 186–192. https://doi.org/10.2337/ds24-0021