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In our latest episode of "In the Interim...", Dr. Scott Berry sits down with Dr. Roger Lewis to discuss the role of Data Safety Monitoring Boards (DSMBs) in adaptive trials. Gain insights into how the role of the DSMB is evolving as clinical trials are becoming more complex with

Data Safety Monitoring Boards (DSMB) serve a crucial role in clinical trials—safeguarding participant safety and ensuring trial integrity. While investigators design adaptive trials to be more efficient, once underway, they're blinded to accumulating data. DSMBs are charged with

In traditional fixed-size clinical trials, the Data Safety Monitoring Board (DSMB) primarily focuses on identifying safety signals and unforeseen operational challenges. However, the role of the DSMB expands significantly in adaptive trials. These trials involve complex,

In adaptive clinical trials, a robust Data Safety Monitoring Board (DSMB) is crucial. On the latest episode of "In the Interim…", Dr. Roger Lewis explains that a DSMB must understand the statistics behind the design, ensuring that the trial operates as intended even when

Navigating the realm of Data Safety Monitoring Boards (DSMBs) in adaptive trials is no small feat. Dr. Roger Lewis, Senior Medical Scientist, provides his insights into the increasingly impactful role of DSMBs in innovative trial designs and conduct. Discover how these

We're excited to announce the newest episode of "In the Interim...", featuring a unique intersection of sports and drug development. Join Dr. Scott Berry and Dr. Nick Berry as they explore lessons from the sports world and their application to clinical trials—focusing on the

Dr. Scott Berry explains how understanding regression-to-the-mean provides critical insights into sports and drug development. Taking the 2017 US Open as an example: golfers in the worst quartile on day one, who averaged 78 on day one, averaged 75 on day two – a 3 shot

Dr. Scott Berry and Dr. Nick Berry describe how in clinical trials, what’s called the “placebo effect” is often "regression-to-the-mean" and not an effect of taking a placebo. Baseline variability is not just a minor detail—it's crucial to understanding trial outcomes. When

Consider a scenario in a phase 2 trial where 10 out of 20 patients in a subset respond favorably, and in the remaining patients 25% respond favorably. What is the right inference for the subgroup? 50% response rate? A 25% response rate? Something in the middle? Thinking at the

Regression-to-the-mean is more than just a statistical oddity—it's a critical lesson for clinical trials and sports alike. Our latest blog post explores the surprising parallels between these two worlds. Discover how a golf tournament's variability mirrors trial outcomes, and

On the latest episode of the "In the Interim..." podcast, Scott Berry is joined by Prof. Craig Ritchie, EPAD Chief Investigator and Founder of Scottish Brain Sciences, to challenge the status quo in Alzheimer’s Disease trials. The European Prevention of Alzheimer’s Dementia

Dr. Scott Berry and Prof. Craig Ritchie discuss how EPAD produced the largest Alzheimer’s disease readiness cohort to date yet never launched a trial arm. Why? Upon investigation a clear pattern emerges: • Sponsors hesitated to place high-value investigational assets onto an

The IMI funding was designed to initiate a platform trial, and it would be sustained by sponsors paying for platform entry. Yet, by the end of the five-year grant, no platform trial arms had been enrolled. As Professor Ritchie stated, “You could almost argue there’s a €64

Despite rapid advances in biomarkers, imaging, and new therapies for neurodegenerative diseases, many clinics still function as they did decades ago. The gap between scientific progress and day-to-day clinical delivery is widening. Professor Craig Ritchie saw these operational

Dr. Scott Berry exposes a core misconception in adaptive trials on the latest episode of “In the Interim...”. "Spending alpha" is the notion that interim analyses ‘cost’ alpha or impose a penalty. This is a statistical fallacy. Alpha is not lost by looking; it’s affected only

Dr. Scott Berry explains how the clinical trials industry continues to cling to outdated protocol language. In a phase 3 superiority trial, the correct standard is a one-sided 2.5% type I error, not a two-sided 5% alpha. Most protocols would fail a basic statistics course on

Let’s end the “alpha penalty” language in adaptive trials. The term "alpha penalty" is a misnomer. You don’t lose alpha by conducting interim analyses in adaptive designs; you’re distributing the same 2.5% type I error—nothing is lost. This persistent myth deters better trial

Some pharmaceutical companies still write protocols that reduce the final alpha by 0.001 during a futility analysis—when no efficacy look is performed. As Dr. Scott Berry puts it: “It drives me nuts.” The first question: Are you considering stopping for efficacy at the futility

The phrases “spending alpha” and “alpha penalty” persist. The phrasing creates a misunderstanding that adaptive designs and interim analyses are bad and come with a cost. The opposite is true – adaptive designs can create scientifically stronger, more efficient trial designs –

What is the right sample size for your clinical trial? Simple, the one that is not too small and not too big, but the one that is just right! In today’s blog, Dr. Nick Berry and Dr. Elias Meyer introduce you to the aptly named Bayesian adaptive sample size approach: The