Statsols Blog

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

Predictive Analytics: From Proverbs to PX

The concept of Predictive Analytics is nothing new. The basic idea of using the past to predict the future is in fact very old. Many old phrases we still use today is an example of predictive analytics in very simple forms. If you ever heard the phrase ”Red sky at night, sailors delight” then you will realise sailors have been already using predictive analytics for the longest time.

Topics: PX Analytics Predictive Analytics

How the "sexiest job of the 21st century" will be automated by 2025

Before I tell you how experts are predicting that the sexiest job of the 21st century is going to be automated by 2025, have a guess what it is? You may be surprised to learn it is not the traditional jobs we may think that are top of the list, such as lawyers, pilots, doctors or stockbrokers.

Topics: PX Analytics Automation

Intact social cognitive processes in outpatients with anorexia nervosa: a pilot study

nQuery Sample Size Calculator has been featured in another interesting study.

The aim of this article "was to assess social cognition in community patients suffering from anorexia nervosa (AN) compared to healthy controls".

Anorexia  nervosa — often simply called anorexia — is an eating disorder with an intense fear of gaining weight. People with anorexia go to extreme lengths in order to avoid gaining weight. This has a huge impact on them both physically and mentally.  

Below is an abstract from the article

The research hypothesis indicated that patients suffering from anorexia represent no significant difference in social cognitive functioning in comparison to the healthy controls. These assessment scales were used to identify whether there are any problems according to social cognitive functioning especially emotion recognition and theory of mind (ToM). The primary outcome assessment was to identify social cognitive deficits in anorexic outpatients and secondary outcome was to verify whether these problems in emotional functioning found in women in acute phase of AN are state or trait effects. Full Article

Topics: nQuery Publications Citing nQuery Sample Size Calculator

STUDY: Pre-surgical depression and anxiety and recovery following coronary artery bypass graft surgery

nQuery Sample Size Calculator has been featured in another interesting study, this time published in the Journal of Behavioral Medicine.

The study states that "co-morbid depression is commonly observed in patients suffering from coronary heart disease (Dickens 2015). Two landmark studies documented the impact of depression on survival following coronary artery bypass graft (CABG) surgery".

The study "aimed to explore the combined contribution of pre-surgical depression and anxiety symptoms for recovery following coronary artery bypass graft (CABG) using data from 251 participants. Participants were assessed prior to surgery for depression and anxiety symptoms and followed up at 12 months to assess pain and physical symptoms, while hospital emergency admissions and death/major adverse cardiac events (MACE) were monitored on average 2.68 years after CABG." 

Topics: nQuery Publications Citing nQuery Sample Size Calculator

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

Power Combined with Precision Helps Improve Sample Size Justification


Topics: Power & Sample Size