Kid Tested, FDA Approved: The Science of Pediatric Clinical Trials

Unbiased Science

@unbiasedscipod

Education, Science, Health & Fitness

4.4 • 644 Ratings

🗓️ 18 February 2026

⏱️ 35 minutes

🔗️ Recording | iTunes | RSS

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Summary

In this episode, Jess and Sarah welcome Dr. Neil Goldenberg to explore the unique challenges and complexities of conducting pediatric clinical trials. The scientists examine the necessity of multi-center studies, ethical considerations specific to research involving children, and the critical physiological differences between pediatric and adult populations that require distinct research approaches. Dr. Goldenberg shares valuable insights from his research experiences, including the KidsDOTT and COVAC-TP trials, while discussing the essential roles of funding and infrastructure in advancing pediatric research. Throughout the conversation, the experts emphasize the importance of collaboration and advocacy in this field. The episode concludes with an optimistic perspective on the future of pediatric clinical research and its potential to improve health outcomes for children. Watch the conversation on YouTube: https://youtu.be/yqS4b3kqHHM (00:00) Intro & Public Health Update (05:33) What's A Health/Science News Item That Caught Your Attention? (07:34) What Is A Multi-Center Study? (09:35) What Protections Are There For Human Subject Clinical Trials? (13:04) Why Is There A Need For Separate Trials For Children Vs Adults? (17:42) Examples of Dr. Goldenberg's Trials (24:50) What Does It Mean If Pediatric Trials Don't Get Funded? (29:13) Is There Anything We Can Do To Support Pediatric Clinical Trials? (31:51) What's Giving You Hope In Public Health And Science Right Now? https://www.hopkinsmedicine.org/all-childrens-hospital/ https://www.linkedin.com/in/neil-goldenberg-md-phd-59226b63 Disclaimer from Dr. Goldenberg: "The opinions I share during this conversation are my own and do not necessarily reflect the official positions or policies of my employer." ----------------------------------------------------------------------------------------------------------------------- Interested in advertising with us? Please reach out to advertising@airwavemedia.com, with “Unbiased Science” in the subject line. PLEASE NOTE: The discussion and information provided in this podcast are for general educational, scientific, and informational purposes only and are not intended as, and should not be treated as, medical or other professional advice for any particular individual or individuals. Every person and medical issue is different, and diagnosis and treatment requires consideration of specific facts often unique to the individual. As such, the information contained in this podcast should not be used as a substitute for consultation with and/or treatment by a doctor or other medical professional. If you are experiencing any medical issue or have any medical concern, you should consult with a doctor or other medical professional. Further, due to the inherent limitations of a podcast such as this as well as ongoing scientific developments, we do not guarantee the completeness or accuracy of the information or analysis provided in this podcast, although, of course we always endeavor to provide comprehensive information and analysis. In no event may Unbiased Science or any of the participants in this podcast be held liable to the listener or anyone else for any decision allegedly made or action allegedly taken or not taken allegedly in reliance on the discussion or information in this podcast or for any damages allegedly resulting from such reliance. The information provided herein do not represent the views of our employers.

Transcript

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0:00.0	You're listening to an Airwave Media podcast.
0:27.2	Welcome to Unbiased Science, where we bring scientific method to the madness.
0:31.8	We're your host, Dr. Jess Steyer, and Dr. Sarah Scheinman. And this week, we are talking about pediatric clinical trials. These are the really important things that go on
0:42.0	in the background before we see medications, vaccines, all kinds of things, hit the market and become
0:48.7	available for our children. And so we have a very special guest, Dr. Neil Goldenberg, whom Sarah will introduce in
0:56.4	just one moment, who is an expert on this and has run many pediatric clinical trials of his own.
1:03.1	And we can't wait to pick his brain. Before we do that, we'll kick off the episode with a little bit of a public health update.
1:12.4	And I chose this because it felt kind of relevant to today's episode.
1:17.0	So this, we're recording this on February 16th.
1:20.7	And this headline came out, I think it was last week.
1:24.6	So I don't know, whatever week ago was the first week in February. And the
1:30.4	headlines were, FDA won't review Moderna application for first MRNA-based flu vaccine. And this
1:39.0	decision has really shocked company officials, and it comes as the FDA says it will take a stricter approach
1:45.8	to federal vaccine approvals. Now, we did a social media post on this. I'm just going to hit
1:50.6	on some of the points here. I think it could be relevant for our conversation later. So the
1:56.1	FDA issued Moderna a refusal to file letter for its MRNA flu vaccine.
2:02.3	And that means that the agency isn't rejecting it.
2:05.5	It's actually refusing to even review the application.
2:09.1	It won't even open it and review the application.
2:11.9	Moderna, to no one's surprise, is none too pleased about this, right?
2:17.1	They said that the letter raised no issues around safety or efficacy.
2:22.4	The issue was with which vaccine they used as a comparator in their trials.
	...

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