Sample Size Expert Blog

5 Reasons Why Pharma Companies Are Calculating Bayesian Assurance

The pharmaceutical industry is increasingly turning to Bayesian methods in an attempt to improve efficiency and enhance decision making. Assurance (Bayesian Power) is becoming a key feature of these Bayesian methods. This is not to replace traditional power but to complement it.

Topics: Clinical Trials Bayesian Assurance nQuery Bayes sample size determination

Dose Escalation: Quickly determine the Maximum-Tolerated Dose through Continual Reassessment Method

A key drawback of the traditional 3+3 design in dose escalation is its slow processing of data to reach the target dose. In contrast, the Continual Reassessment Method designs produce an expedited convergence to the target dose or the doses near target.

Topics: Clinical Trials Dose Escalation Continual Reassessment Method (CRM)

Why Frequentists are using Bayesian Statistics in Clinical Trial Design

Statisticians are familiar with the long standing debate regarding Frequentists Vs Bayesian methodologies and the benefits (or negatives) that each present to a particular situation. However, we are now experiencing a rise in traditional frequentists using Bayesian statistics. What are the reasons behind this? While complex, we can identify two high level points.

Topics: Clinical Trials Bayesian Assurance nQuery Bayes

Top 10 Corporate Clinical Trial Sponsors of 2016

Following on from our previous blog post, The Most Popular Clinical Trial Drugs of 2016, we thought it would be a good idea to take a closer look at the Top 10 Corporate Clinical Trial Sponsors of 2016.

In this post, we explore these Top 10 companies, looking at their developmental histories as well as the drugs they have developed and the number of subjects required for their 2016 registered trials.

Topics: Power & Sample Size Clinical Trials Clinical Trial Sponsors Top10

15 Ways to Reduce Sample Size In Clinical Trials

How do you reduce sample size in clinical trials? Reducing sample size without losing power can be accomplished in one of three principles. This paper examines these methods and demonstrates 15 ways to reduce sample size in clinical trials.

Topics: Power & Sample Size Clinical Trials Reduce Sample Size

What is the difference between Superiority vs. Equivalence vs. Non-inferiority in clinical trial design

The terms superiority, equivalence and non-inferiority are used frequently in publications on clinical trials. To someone starting out in clinical research these three terms and their precise meaning can be quite difficult to grasp. Indeed even experienced researchers have trouble getting their head around these hypotheses. So, what do these terms mean?

Topics: Introduction to Sample Size Clinical Trials nQuery

Making it personal: N-of-1 trials, allowing for individuality but not overdoing it

N-of-1 trials are the application of the machinery of randomised clinical trials to the individual patient. Episodes of treatment rather than individual patients become the fundamental unit of inference and patients are repeatedly randomised to an experimental and a control treatment (say) in order to establish the effect of treatment. Popular designs involve cycles of episodes of treatment with the patient being assigned to a random order within cycles. (Continued below)

Topics: Power & Sample Size Clinical Trials N-of-1 Trials Stephen Senn

Clinical Trials Data Dive - Results from 220,000 clinical trials

Statsols looked at data from 220,000 clinical trials. Below are just some of the points we found.

As you may know, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires the registration and submission of summary results of clinical trials with The law applies to certain clinical trials of drugs (including biological products) and medical devices. At the time of publishing currently has over 220,000 clinical trials registered. We examined the data to get some interesting results on a few topics such as:

Topics: Clinical Trials