A clinical trial is often designed to demonstrate that a new treatment is performing better than the currently available treatment. To do this, one must show that there is a positive difference between the new and old treatments, and that this difference is statistically significant. To determine statistical significance, we use statistical hypothesis testing procedures….
COVID-19 disruption of clinical trials is likely to result in missing data, disrupted timelines, and perhaps patient population changes. We thought we would dedicate a blog post to the actions that can be considered when a study is facing the issue of missing data. The COVID-19 situation is clearly still developing and regulators are still…
In this blog we will discuss a particular type of clinical trial design, the non-inferiority trial. We will explain the difference between non-inferiority trials and more typical clinical trial designs to help build understanding of the non-inferiority limit. Standard clinical trials usually aim to show that a new treatment is better than an existing one….
What do ISS & ISE mean? ISS & ISE stand for integrated summary of safety and integrated summary of effectiveness, respectively. These are not merely summaries, as the name might suggest, but rather documents comprised of integrated analyses of the safety and effectiveness of a study drug [1]. In other words, the results from all…
In our previous blog on survival analysis, we touched on some of the characteristics of survival data and various fundamental methods for analysing such data, focusing solely on non-parametric methods of analysis which only estimate the survival function at time points within the range of the raw data. I mentioned in the conclusion that parametric…
We have discussed Handling Missing Data in Clinical Trials elsewhere, and mentioned a kind of missing data known as ‘censoring’. In this blog we focus on techniques for dealing with this, known as ‘Survival Analysis’. Censoring occurs in time-to-event data (the time from a defined origin until the event of interest), when the event has…
The Safety Population is used for the analysis of safety, including adverse events, toxicity and laboratory evaluations. A patient should be included if, and only if, they actually received a study treatment (even if it is a placebo). This set of patients are grouped for analysis according to the treatment they actually received, as opposed…
This 3rd clinical trial design blog from Quantics Biostatistics takes an introductory look at how the various types of clinical endpoints (introduced in our previous blog) determine the recommended calculations for what can be inferred from summary data. Formal statistical testing for a clinical trial is traditionally based on the concept of proof by contradiction….
In our last blog we discussed sample size choice and identified the key information that your statistician needs to know and why. In this second clinical trial design blog, we look at the different types of endpoints in clinical trials and some of the statistical issues they raise. Read our blog on sample size choice…
Welcome to Quantics’ Clinical blog. This blog will explore some of the statistical aspects of clinical trial design including study design, sample size, data management and analysis planning. The aims of this blog are not only to provide thought provoking insight into some of the latest statistical developments for clinical trials but also to create…