To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. on the podcast.
Dr. Beck currently oversees clinical operations, clinical strategy and science, biometrics and human factors at Dexcom Inc, a leading manufacturer of continuous glucose monitors (CGMs)
Prior to joining Dexcom, Dr. Beck worked at Food and Drug Administration for over ten years, spending time as a scientific and regulatory reviewer, a chief of the Diabetes Diagnostic Devices Branch, and Deputy Office Director of Personalized Medicine and Molecular Genetics.
Dr. Beck received her Ph.D. in Biomedical Science from the University of California San Diego, and her B.S. in Chemical Engineering from the University of Texas at Austin.
She also received her Master of Public Health (MPH) in Epidemiology from University of Maryland Baltimore.
In her free time, she enjoys spending time with her kids, reading, hiking, and running.
I hope you enjoy my conversation with Dr. Stayce Beck.
Sponsor(s):
This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/
This podcast is brought to you by Veeva SiteVault. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
Referenced Materials:
UT Austin Chemical Engineering
University of Maryland Masters in Public Health
Show Notes:
[0:20] Kunal Intro and Dr. Beck
background
[2:04] Sponsor Break: Viva Vault
[3:03] Dr. Beck explains her background, education, and experience with the FDA.
- BS Chemical Engineering – University of Texas Austin
- PhD Biomedical Science – UC San Diego
- Masters in Public Health – University of Maryland Baltimore
[9:17] Dr. Beck discusses her insights into best clinical trial design practices
- Try to understand what insights the study design will provide
- Determine what the right question is that needs to be answered
- Understand the research methods of the specific indication of study
[13:45] Different clinical trial design endpoints
- Linearity
- Accuracy
- Precision
[16:24] What are things you saw sponsors were doing wrong and how can they improve?
- Clear writing and organized appendix
- Understand the reviewer may not know what your device does
- Clearly define what you’re measuring and why it matters
- Articulate any study confounders or biases
[19:57] FDA considerations around different protocol amendments, study versions and sets of results
- Make sure criteria changes are explained clearly
- Articulate rationale for why changes were made
[21:50] What should patients be asking their doctors when it comes to metabolic health?
[23:51] Sponsor break: Viva and Calyx
[26:42] Standard of care and metabolic tests to ask your doctor about
- Mostly standard of care blood tests
- Make sure your doctor is reviewing HDL, LDL total, triglycerides, and thyroid markers
[27:50] Metabolic disorder research questions answered in the last 10 years
- Continuous Glucose Monitors have been major focus of last 10 years
- Automatic insulin delivery was a major milestone
[32:01] Metabolic disease medical products and misunderstandings about CGMs
- Lancets and blood glucose meters are an alternative to CGMs
- Glucagon injections help to raise blood glucose levels if needed
- Many people mistakenly assume CGMs are more expensive or won’t be covered by insurance
[36:10] Where is diabetes at currently and how can someone get involved in research
[39:48 ] Keeping up with clinical research and recommended reading
[41:08] Diversity in diabetes clinical trials
- Need to purposefully and intentionally pursue diverse populations
- Educating people about studies helps to encourage them to participate
[43:44] Surveys and patient reported outcomes
- Surveys help to be a voice for patients
- Very powerful to the FDA to show how people using the device feel about it
[45:27] Safety in diabetes clinical trials
[47:32] Dr. Beck’s recommended reading
[49:31] Outro and Sponsor Break: Calyx
