Biometrics, the final touch..... of clinical research

Biometrics department in a CRO is a place where all clinical trial data's are analyzed using software’s (like SAS). The study protocol, Case Report Forms (CRF), Statistical Analysis Plan (SAP) & mock are read by the programmers for data analysis. This data analysis involves:

I. Deriving the dataset:

For example: The raw dataset may contain two variables namely,

a) Birth date of the patient &
b) Visit date of the patient

but it may not contain a variable called: “age”.

In order to derive the variable “age” from birth date and visit date, programmer's write code [age = int ( (visitdt - birthdt) / 365.25 ) + 1;]. Like wise many other variables are derived from the raw dataset to make a derived dataset. These derived datasets make table programming much easier.

II. Listing:

Next step is the listing of data's from the derived datasets (with little or no SAS programming).

III. Tables:

Here the programmer’s subset data according to the mock.

Listings and Tables are done based on these data's:

1) Demographics
2) Patient disposition
3) Vital signs / Lab test
4) Adverse event
5) Study drug
6) Disease progression / Death
7) Efficacy

The ultimate aim of Bio (Biological) metrics (Measurement) is to find out:

1) The difference between treatment groups
2) Change from baseline to end of study and
3) Comparison of patient subsets