This is the 5th episode of the “What’s Her Problem?” Interview Series. I hope you enjoy it and would love to hear your feedback!
Note: Closed captioning and the full transcript are available after you click through to the video above.
Article Voiceover:
In honor of Health Literacy Month, I sat down with Sylvia Baedorf Kassis, MPH. We talked through “Clinical Research 101,” defining the basics of Clinical Research and the phases of Clinical Trials. Sylvia also provided an incredible overview of the history of ethics and justice in Clinical Research and how informed consent and patient participation continues to be improved. Overall, our conversation will give you a good sense of how the medications in our medicine cabinets and the medical devices we have in and around our bodies come into existence.
Sylvia Baedorf Kassis has more than 25 years of clinical research-related experience in Canada and the United States of America. In her current role at the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, Sylvia champions efforts to make clinical research more understandable and accessible to patients, participants, and caregivers through her work on Health Literacy in Clinical Research and the first-of-its-kind, plain language Clinical Research Glossary. Sylvia is passionate about patient/participant engagement, and as such strives for inclusivity in the programs she leads so that patient/participant voices are prioritized.
Sylvia’s clinical research interests include: understanding study participants’ experiences in research and incorporating their insights into study processes; supporting research teams and study sites through networks and capacity-building; and ensuring all research interest-holders have the resources they need to conduct ethical and compliant studies involving study participants and their data/samples.
Sylvia earned a Master of Public Health degree in Global Health from Boston University School of Public Health (2008) and a Bachelor of Science from the University of Toronto (2001).
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THANK YOU, and enjoy my chat with Sylvia!
Each issue of “What’s Her Problem?” includes questions for further discussion. Leave a comment below!
This week’s questions:
Have you ever participated in a clinical trial or survey? If you have, what motivated you to participate, and would you do it again? If you have never participated, what are the barriers to your participation, and what kind of additional information would you need to learn in order to do so?
(Note: If you have been a clinical trial participant, please don’t identify the name of the study here.)
Show Notes:
0:00-1:04 Welcome back to the Interview Series
1:05-2:02 Introducing today’s topic
2:03-3:31 Sylvia’s Bio
3:32-4:30 Sylvia and Debra opening greetings
4:31-6:31 Why is Health Literacy Month important to Sylvia?
6:32-9:49 How Sylvia got into the field of Clinical Research
9:50-12:04 Sylvia’s interest in a Lyme vaccine trial
12:05-12:54 Clinical trials don’t mean you’re being “experimented on”
12:55-16:04 Clinical Research 101
16:05-18:14 MRCT Center Clinical Research Glossary
18:15-29:09 The History of Ethics and Justice in Clinical Research
29:10-36:39 Clinical Trial Phases 1-4
36:40-42:30 How patients become Clinical Trial participants
42:31-53:37 Informed consent, eligibility, and the risks and benefits of Clinical Trial participation
53:38-1:00:37 Debra’s Clinical Trial Experience and the importance of sharing research results with patients
1:00:38-1:04:47 The effects of research funding cuts at Harvard (A question from an Open-Hearted Supporter of “What’s Her Problem?” Subscribe now at whatsherproblem.substack.com to be able to ask your own questions to future Interview Series Guests!)
1:04:48-1:08:16 Wrap-Up
The MRCT Center Clinical Research Glossary:
https://mrctcenter.org/glossary/
Clinical Trial Registries:
NIH Draft Policy on Return of Research Results (available for public comment through 10/26/26):
https://osp.od.nih.gov/policies/return-of-research-results#tab1/
Sylvia Baedorf Kassis on LinkedIn:
https://www.linkedin.com/in/sylvia-baedorf-kassis-mph-cyt-9418737/
MRCT’s Free Webinar Series:
https://mrctcenter.org/events/
Sign up for the MRCT Newsletter:
https://lp.constantcontactpages.com/su/UW1q0W5/newsletter
Up Next:
Next week is the 10th anniversary of my open-heart surgery. My article on Friday, 10/9 celebrates this milestone and digs into what that surgery, a septal myectomy, entailed.
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