Parametric tests, such as t-tests and ANOVA, are commonly used in clinical trials in order to establish the efficacy of candidate treatments. However, parametric tests require a number of assumptions to be met including the distribution of the data. In cases where these assumptions may not be met, researchers may consider semi-parametric tests and non-parametric tests which are robust in a wider variety of scenarios.  Semi-parametric methods such as Cox Regression and non-parametric tests such as Mann-Whitney U tests are therefore an essential tool for statistical analysis. Given this, th ..read more

Designing a trial involves considering and balancing a wide variety of clinical, logistical and statistical factors. One decision out of many is how large a study needs to be to have a reasonable chance of success. Sample size determination is the process by which trialists can find the ideal number of participants to balance the statistical and practical aspects that inform study design.  In this interactive webinar, we provided a comprehensive overview of sample size determination, the key steps to successfully finding the appropriate sample size and cover several common pitfalls r ..read more

One of the biggest uncertainties when running a clinical trial is predicting how long a trial will take to reach its goal. Whether predicting the time needed to reach an enrollment milestone or projecting when the required number of events will occur in a survival trial, making informed estimates of how long your trial will be ensures you are best placed to communicate and adapt appropriately with all stakeholders. In this free webinar, we cover how simulations can be used to model and project the time needed to reach an enrollment or event milestone using simulation tools such as nQuery Predi ..read more

Free nQuery GSD training session Below is a recording of a training session that focuses on one of our most requested topics - Group Sequential Designs. When conducting these types of trials there are a wide variety of methods available and theoretical decisions to be made. This recent nQuery GSD training session gets to the core of what we think, can help you the most, in the shortest timeframe. We cover: Ian DeMets Wang-Tsiatis Haybittle Peto How to maximize nQuery's Group Sequential Design features  Designing Robust Group Sequential Trials Free nQuery Training   Nothing showin ..read more

The process of getting a candidate treatment approved is a multi-phase process which takes multiple years, and requires millions of dollars to complete Phase II is usually the first opportunity to test if a candidate therapeutic has a positive clinical response in humans and is also an opportunity to gain insight into the optimal dose for the proposed drug to be brought forward into a Phase III clinical trial. However, Phase II is also the stage of the clinical trial process with the highest failure rate, so good study design is crucial to make informed decisions in a timely manner. In this we ..read more

About the webinar Randomization is a central tenet in the design of clinical trials as it allows trialists to ensure their trial generates valid estimates of the effect of their treatment. However, randomization can take on different forms depending on the practical constraints in a given trial and this can have significant implications on the analysis strategy and the expected power of a trial.  In this webinar, we discussed why randomization is central to good trial design, how different randomization strategies can affect the statistical methods and power and how appropriate randomizat ..read more

About the webinar Sequential designs, where trials can stop early based on interim results, are the most widely used type of adaptive design in clinical trials. Group sequential design is one of the most widely used approaches to designing and analysing sequential trials. However, this class of design has a wide variety of unique theoretical and practical choices that require consideration. In the second of this two-part webinar series, we discuss the different types of group sequential design and the best approaches for maximising the value of this trial design type. Group Sequential Design T ..read more

About the webinar In the first of this two-part webinar series on group sequential design, we introduce sequential design, some of the most common design choices and issues that can arise and provide an introduction to group sequential design and the specific choices available for this class of sequential design. Practical Guide to Sequential Design Primer on Sequential Design Methods and Design Choices In this free webinar you will learn about: Sequential Design Types and Overview Common Sequential Design Choices and Issues Practical Guide to (Group) Sequential Design  More about th ..read more

About the webinar Survival analysis is one of the most common statistical approaches used in clinical trials, especially in clinical areas such as oncology. It is also one of the most complex and flexible statistical areas with this increasing in recent years due to the emergence of innovative treatments such as immunotherapies. This complexity affects every part of trial design and analysis including power analysis and sample size determination. In this webinar we look at the key concept for power analysis for survival trials and some of the challenges that a researcher can face including acc ..read more

About the webinar The scientific method is the bedrock of clinical research but the gap between theory and practice can be significant. A recent development to bridge this gap has been the development of the estimand framework which looks to link the study objective, design and estimates together while accounting for real-world challenges such as inter-current events like patient dropout. ICH E9 (R1) was a major step forward for the adoption of the estimand framework but significant research and debate continues on how best to utilise the framework. We are delighted to host the first episode i ..read more