Protocol Design Featured Articles
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Validating A Better ALS Biomarker With Coya’s Fred Grossman
4/24/2024
Coya Therapeutics President and CMO Fred Grossman, DO, FAPA discusses a potential new biomarker for ALS — 4-HNE, an oxidative stress biomarker — and how it could be more effective than the current standard, NfL.
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Will Today’s Clinical Trial Trends Become Tomorrow’s Routine?
4/23/2024
Clinical trial trends can be divided into two groups — those related to changes in the conduct of clinical trials and those related to the changes in therapeutic areas. Will these trends hold steady as 2024 unfolds?
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Yes, Women’s Exclusion In Clinical Trials Is Still A Problem
4/22/2024
Despite the progress made in including women in clinical trials, challenges persist. Hera Biotech CEO Somer Baburek explains why the fight for inclusion isn't over.
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How To Determine Country Feasibility For Cell And Gene Therapy Clinical Trials
4/17/2024
Learn how to choose the right location — globally — for your next cell and gene therapy clinical trial.
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Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints
4/16/2024
The idea of leveraging novel, sensor-based measures to gather data for clinical trials is not new, but relevant evidence of their usefulness is. Here, DiMe experts discuss the impact of digital endpoints on trial success.
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Mission: Remission — Patient Need For Durable Treatment Informs J&J’s Ulcerative Colitis Trial
4/15/2024
J&J Global Therapeutic Area Head, Immunology, David M. Lee, MD, Ph.D., talks about the progression from treating PsO and PsA to UC, the importance of integrating patient needs into the trial’s design, and the quest for a durable treatment that lends itself to total remission.
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Looking Back & Moving Forward With J&J’s Global Development Leader For Immunology
4/15/2024
In this Q&A, David Gordon, M.B., Ch.B. recounts lessons learned from past clinical trial challenges and shares current-day strategies, like figuring out how to run a study that’s both scientifically sound and actually doable for patients and doctors.
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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.