Welcome to Womble Perspectives, where we explore a wide range of topics, from the latest legal updates to industry trends to the business of law. Our team of lawyers, professionals and occasional outside guests will take you through the most pressing issues facing businesses today and provide practical and actionable advice to help you navigate the ever changing legal landscape.
With a focus on innovation, collaboration and client service. We are committed to delivering exceptional value to our clients and to the communities we serve. And now our latest episode.
Host A:
Welcome back to Womble Perspectives, where we break down complex legal and regulatory developments into practical insights. Today, we’re diving into where science, transparency, and litigation meet: the arena of clinical trial reporting.
Host B:
That’s right, and today’s discussion is sparked by a recent FDA reminder sent to more than 2,200 medical product companies and researchers. The message was fairly straightforward: you are required to submit certain clinical trial results to ClinicalTrials.gov.
Host A:
Seems simple enough, and like it would be common practice already. But apparently not. According to the FDA, nearly 30% of studies that are highly likely to require reporting still have no results on file.
Host B:
So, maybe not so common in practice. And the FDA presented not only that statistic, but consequences as well. When unfavorable findings aren’t reported, the public record becomes incomplete.
Host A:
And that incompleteness feeds into what’s known as publication bias. When only positive findings are visible, the overall perception of a medical product’s safety and effectiveness can become distorted.
Host B:
And more importantly, at least for what we’re focusing on today, this isn’t just a problem for clinicians or researchers. The ripple effects extend into the legal world, particularly in litigation.
Host A:
Right. Because when the scientific literature is skewed and when positive results are overrepresented, it shapes how experts evaluate key issues like causation, safety, and a product’s regulatory history.
Host B:
Which brings us to Daubert and Rule 702, rules that essentially govern whether expert testimony is admissible in court.
Host A:
Under these standards, trial courts take on a gatekeeping role. They’re tasked with ensuring that expert opinions are based on sufficient facts or data, and that those opinions are the result of reliable methods applied appropriately to the case.
Host B:
So if the underlying scientific literature is incomplete because negative or null results were never reported, then the “facts or data” an expert relies on may not actually reflect the full picture, opening the door for scrutiny. Counsel can question whether an expert’s opinion is grounded in the entire evidentiary record or just a selectively reported subset of it.
And that shifts the focus from simply evaluating what an expert says to examining what they may be missing.
Host A:
So what can attorneys do in practice? Well, one thing is to compare published articles with other sources like study registrations and posted results.
Host B:
And that comparison can reveal gaps. For example, you might find studies that were completed but never reported, or discrepancies between what was initially registered and what was ultimately published, or even cases where publications appear to present only part of the underlying data. All of these scenarios raise questions about completeness and reliability.
And importantly, this type of inquiry fits squarely within the Daubert and Rule 702 framework with direct implications for admissibility and credibility.
Host A:
Of course, the article also acknowledges limitations. Not every undisclosed study can be identified. Some research might never be registered, and some results may never be posted at all. And even when records are available, discrepancies aren’t always obvious. So there’s an inherent challenge in trying to reconstruct the full evidentiary landscape.
Host B:
In other words, even if you can’t find every missing piece, the effort to look for gaps can still be incredibly valuable in litigation.
Host A:
So whether you’re a legal professional, a researcher, or someone working in regulatory affairs, this is a reminder that the integrity of the record matters—and gaps in that record can have far-reaching consequences.
Host B:
That’s all for today’s episode. And as always, we’ll be back with more insights to keep you informed and ahead of the curve.
Thank you for listening to Womble Perspectives. If you want to learn more about the topics discussed in this episode, please visit The Show Notes, where you can find links to related resources mentioned today. The Show Notes also have more information about our attorneys who provided today's insights, including ways to reach out to them.
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