Dan Schell articles
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What To Expect From An FDA Inspection
4/26/2024
Former FDA inspector turned regulatory consultant, Patrick Stone, gives some valuable insights to what to expect when the FDA comes knocking at your clinical trial site. Here's a hint: make sure you PI knows the difference between presiding over and overseeing a study.
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Why Can’t We Compare Site Performance Measures?
4/22/2024
Cerdi Beltré believes it’s possible to develop a global and objective way to measure investigator site performance for metrics such as startup duration, screen-pass rates, or rate of enrollment. It just won’t be easy … or make some sites happy.
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Ignoring Digital Biomarkers Will Be Your Undoing
4/12/2024
We are still in the early days of uncovering all the advantages of digital biomarkers. “It’s difficult to figure out what you can measure repeatedly and with some sense of validity,” says Bari Kowal, SVP, development operations, portfolio management & biostatistics data management at Regeneron.
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4 Questions About A Digital Therapeutic Clinical Trial
4/8/2024
Tim Peters-Strickland, SVP, clinical development & medical affairs at Click Therapeutics, explains some of the details that went into the recently FDA-approved Rejoyn digital therapeutic, which was a joint collaboration between Otsuka and Click.
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Dear Data Analysts, AI Is Not Replacing You
4/2/2024
Deep beneath the ongoing narrative of AI’s potential use cases in clinical trials is the same fear that persists in other industries facing this technology revolution. Namely, will jobs be lost and replaced by machines? So, I thought I’d ask an expert — a machine.
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Why Jane Myles Believes DCTs Are “Completely Doable”
3/27/2024
If you want to know about how perceptions regarding DCTs are changing, talk with Jane Myles of the DTRA (Decentralized Trials & Research Alliance). As Program Director at DTRA, she is acutely aware of all the challenges and opportunities surrounding anything with the term “decentralized trial.”
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How Takeda Leverages Cultural Competency Training To Improve Diversity
3/14/2024
Karen Correa, VP, head global clinical operations at Takeda, details some uncommon ways the pharma is tackling the problem of diversity in clinical trials.
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Do ClinOps Professionals Understand The CAR-T Supply Chain?
3/4/2024
Lee Clough RN, HP, of Novartis talks about the importance of understanding the nuances associated with collecting and shipping autologous material (i.e., CAR-Ts) for clinical trials.
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Ramblings From A First-Time SCOPE Attendee
2/15/2024
Dan Schell, chief editor of Clinical Leader, discusses what sessions stood out to him and some of the KOLs he rubbed elbows with while attending his first SCOPE Summit.
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No Surprise: Patient Recruitment Still Sucks
2/14/2024
Patient recruitment expert Ross Jackson talks about why this part of the clinical trials ecosystem is still a problem and offers up some solutions, specifically around digital/social media outreach.