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…
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….
Interpolation analysis is used to find the concentration of a substance in a sample. For biologics, this is often used in ELISA and other bioanalytic analyses. This blog introduces interpolation analysis for ELISA and presents a new method developed by Quantics. The Bursa-Yellowlees Method uses the available ELISA data more effectively and greatly simplifies the…
In an ideal world, a single randomized controlled trial (RCT) would be used to compare and evaluate the individual treatment effects for all possible treatments of interest. Of course, this is often not feasible, in which case network meta-analysis (NMA) can be used to link RCTs with common treatment arms and compare treatments across different…
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…
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…
In our previous blog we looked at study populations and the issues that often arise along with the best practices for dealing with them. One of the issues we highlighted was missing data so this 5th clinical trial blog from Quantics Biostatistics discusses what actions can be taken when study endpoints are missing from the…
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…
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…