Interim analyses are common in medical device trials for a variety of reasons. When the outcome of the analysis could change the conduct of the trial, for example by early stopping for superiority, futility or safety, then it is important that this is accounted for in the statistical analysis. Alpha spending is one such method…
If you’ve ever taken a rapid test for COVID-19, then you’ve used an in vitro diagnostic device (IVD). At the start of the pandemic, the only reliable method for determining whether a patient was currently infected with COVID was a slow PCR test which required processing in a lab to return a result. By contrast,…
Unless you’ve been hiding under a rock for the past few months (and, honestly, who could blame you), you will have interacted with artificial intelligence (AI) in some form. Whether it’s using ChatGPT to write an email to that one client you wish would go to your competitor or bemoaning the vagaries of the TikTok…
There are essentially two types of allocation we can make when forming clinical trial groups. The first is a random allocation, which, as you would expect, is unpredictable: the study group to which the subject is assigned is unknown before the process takes place. The second is formally known as deterministic, but we’re going to…
Designing and running a clinical trial for a medical device is expensive, and to avoid wasting money, time and risking the validity of the trial, it is important to get the design right. To provide a little more insight, we thought we would discuss some recurring errors that Quantics has observed in trial synopses and…
Interim analyses are common in medical device trials for a variety of reasons. Just having a look is fine, but if the outcome of the analysis could change the conduct of the trial, for example by early stopping for superiority, futility or safety, then there is a problem. If the analysis result does stop the…