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Articles by Alan Kott
3 ISCTM 2025 Findings That Strengthen Clinical Trial Rigor
By Marcela Roy, Joan Busner, Alan Kott, David Daniel Clinical trial quality is often misunderstood as a final checkpoint, when in reality it influences every stage of study execution. This research, presented at the ISCTM 2025 Autumn Conference, explores three interconnected dimensions that shape the reliability and interpretability of CNS clinical trials: reviewer consistency, patient characterization, and measurement efficiency.
How Integrated Analytics And Rater Training Transformed An Atopic Dermatitis Trial
By Maria Visser, Todd Everhart, Marcela Roy, Dr. Alan Kott Dermatology trials pose distinctive challenges, as their clinician-rated endpoints rely heavily on expert judgment, precise interpretation, and methodological consistency across global sites. When a biotechnology sponsor initiated a large Phase 2b atopic dermatitis study spanning more than 110 sites and numerous languages, the complexity made data quality a central operational concern.
A Critical But Addressable Challenge
By Marcela Roy, Sayaka Machizawa, Gary Sachs, and Alan Kott Baseline inflation-the systematic overestimation of symptom severity at study entry-poses a major threat to CNS trial integrity by constraining the measurable range of improvement and obscuring true treatment effects. This bias stems from convergent pressures: sites striving to meet enrollment goals, investigators motivated to help patients access treatment, and participants motivated to qualify.
A Data-Driven Approach To Clinical Trial Site Selection
By Martina Micaletto, Alan Kott, & Petra Reksoprodjo Data quality and integrity are critical to clinical trial success, yet traditional site selection methods often rely on historical familiarity rather than objective performance metrics. Poor site selection can lead to enrollment delays, protocol deviations, and compromised data integrity-challenges that become costly and difficult to resolve once a trial is underway.
10.09.24 -- Why Diversity Of Geography Matters
Webinar: 5 Strategies to Dramatically Improve Clinical Data Quality Join us on October 29th as we unravel the complexities of fragmented data systems, emphasizing the urgent need to adopt technology and processes that harmonize diverse data sources and ensure quality throughout the clinical trial data lifecycle. Discover how to unify data management and augment processes with automation and AI to find and fix data quality issues sooner and more efficiently. Click here to learn more.
Opportunities For Enhancing Signal Detection In Schizophrenia Trials
By David Daniel, MD., Joan Busner, PhD., and Alan Kott, MUDr Schizophrenia clinical trials encounter significant challenges in signal detection due to a limited understanding of the disorder's biological mechanisms, inadequate trial designs, and difficulties in patient selection and efficacy endpoints. A major issue is the recent phase 3 trial failures despite successful phase 2 results.
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