Statsols Blog

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 ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices. At the time of publishing ClinicalTrials.gov 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

Thoughts on the ASA P Values Statement

“When a measure becomes a target, it ceases to be a good measure”

Topics: Industry News

Essential Steps to Determine Sample Size and Power for Clinical Trials

 

 

 

Determination of the appropriate sample size is a crucial part of study design. A sample size must be chosen correctly to allow a study to arrive at valid conclusions. A study that is too small may produce inconclusive results, while a study that is too large will waste scarce resources.

In this white paper we will outline the 5 stage process for determining appropriate power or sample size for clinical trials.


Step 1: Formulate the Study

Before any calculation is conducted, you need to ask yourself a series of questions about the type of analysis you are planning to conduct and therefore what statistical method is most appropriate for your particular study. For exampl

Topics: Power & Sample Size

Monday at JSM 2015, what are you attending?

With JSM 2015 now in full swing here are the talks Statistical Solutions would be attending today, Monday August 10th. 

Today we've focused on techniques for handling missing data with a particular focus on modern and novel techniques and applications in survey research and government statistics. 

Topics: JSM 2015

An Overview of Multiple Imputation in SOLAS for Missing Data 5.0

In our previous post we discussed the pervasive problem of missing data in data analysis. To recap quickly, in a data set with 5 variables measured at the start of a study and monthly for six months, if each variable is 95% complete with a random 5% of the values missing, then the proportion of cases that are expected to be incomplete are 1-(.95)^35= 0.834. That is, only 17% of the cases would be complete and with traditional complete case analysis, you would then lose 83% of your data.

How It Works?

With Solas 5.0TM, missing values in a data set are filled-in with plausible estimates to produce a complete data set that can be analyzed using complete-data inferential methods and designed to accommodate a range of missing data scenarios in both longitudinal and single-observation study designs.

Topics: Missing Data Multiple Imputation Hot Deck Imputation

Missing Data - A Pervasive Problem in Data Analysis

Missing data are a pervasive problem in data analysis. Missing values lead to less efficient estimates because of the reduced size of the database, also standard complete-data methods of analysis no longer apply. For example, analyses such as multiple regression use only cases that have complete data, so including a variable with numerous missing values would severely reduce the sample size.

Topics: Missing Data

Why is Sample Size Important?

A good statistical study is one that is well designed and leads to valid conclusions. This however, is not always the case, even in published studies. In Cohen’s (1962) seminal power analysis of the journal of Abnormal and Social Psychology he concluded that over half of the published studies were insufficiently powered to result in statistical significance for the main hypothesis.

Topics: Introduction to Sample Size

Data Integration and Visualization

Today’s complex clinical trials yield data sets that are almost unimaginably large and complex. As a result, the process of transforming trial data into usable knowledge simply cannot be accomplished using traditional presentation methods such as conventional charts and graphs.

Topics: Industry News

New lung cancer detection instrument moving to clinical trials stage

Owlstone Nanotech, the developers of a promising new lung cancer detection instrument have announced they are now moving their device into clinical trials. The trials are said to begin later this year in a rapid access lung cancer clinic at Glenfield Hospital in Leicester, England.

Topics: News & Events Industry News