The CDISC Study Data Tabulation Model (SDTM) is a standard structure for datasets that are to be submitted to regulatory authorities. The first step of implementing SDTM standards is to develop a mapping specification document. All collected data for a clinical trial needs to be mapped into domains. Typically, not…

What is GDPR?

The General Data Protection Regulation (GDPR) is the primary law regulating how companies protect EU citizens’ personal data. Companies that fail to achieve GDPR compliance are to be subjected to stiff penalties and fines.

GDPR requirements apply to each member state of the European Union. it is aiming to create…

What is a biomarker?

A biomarker is intended to function as a surrogate endpoint. A surrogate endpoint is intended to substitute for a clinical endpoint. A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions, or survivability.

The word surrogate actually comes from the latin…

Most pharmaceutical companies adhere to the ICH E3 guideline “Structure and Content of Clinical Study Reports” when creating a clinical study report (CSR). For exposure analysis , the ICH guideline recommend that the investigational products should be characterized by:

. The number of patients exposed

. The duration of exposure

When designing ADaM analysis datasets, you may have various needs for data categorization. A primary need to categorize data is to group similar values for your analysis.

ADaM standard allows you to create variables that categorize the information in your dataset. …

Programmers are often called upon to program survival analysis and produce tables and figures (For example: Kaplan Meier Curves). Performing such analysts often time involves using PROC LIFETEST

What is survival analysis and the kaplan-meier analysis?

Survival Analysis represents a set of statistical methods used to estimate the length of time between two clearly defined events. Survival data…

The RETAIN statement determins the initial value for a variable The syntax of the RETAIN statement allows it to specify an ‘initial value’ — i.e. its value at the start of the very first iteration of the DATA step. …

Real world evidence must be considered as a complement of randomized controlled trials (RCT). An RCT is always considered higher in the evidence ladder. Most of the time real world study are done prospectively.

Even though real-world evidence studies have lower evidential value than RCT, some techniques can be used…

The Response Evaluation Criteria in Solid Tumors (RECIST) provide standards for solid tumor response assessments. The resist method requires to measure the overall tumor burden at baseline and use it as comparator for subsequent measurements.

Using the RECIST standard you can obtain the following response for a solid tumor

  • Complete…

Christian Baghai

Consultant clinical statistical programmer

Get the Medium app

A button that says 'Download on the App Store', and if clicked it will lead you to the iOS App store
A button that says 'Get it on, Google Play', and if clicked it will lead you to the Google Play store