From The Editor
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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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Debra Weiss, RN: Big Impact In Small, Non-Profit Bio
3/8/2024
The career of Debra Weiss, RN, MSN, and COO at the biopharma Gates Medical Research Institute (Gates MRI), offers a case study in creating success through service-oriented leadership.
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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.
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A Tribe Called SOS
2/5/2024
A first-hand account of a first-time industry conference. Dan Schell, chief editor of Clinical Leader, talks about his impressions of the Save Our Sites (SOS) conference that happened in Tucson, AZ on Feb. 2, 2024.