What is SAS?
The SAS System (originally Statistical Analysis System) is an integrated system of software products provided by SAS Institute that enables the programmer to perform:
data entry, retrieval, management, and mining
report writing and graphics
statistical and mathematical analysis
business planning, forecasting, and decision support
operations research and project management
quality improvement
applications development
Data warehousing (extract, transform, load)
platform independent and remote computing
In addition, the SAS System integrates with many SAS business solutions that enable large scale software solutions for areas such as human resource management, financial management, business intelligence, customer relationship management and more.
data entry, retrieval, management, and mining
report writing and graphics
statistical and mathematical analysis
business planning, forecasting, and decision support
operations research and project management
quality improvement
applications development
Data warehousing (extract, transform, load)
platform independent and remote computing
In addition, the SAS System integrates with many SAS business solutions that enable large scale software solutions for areas such as human resource management, financial management, business intelligence, customer relationship management and more.
Discovering and developing safe and effective new medicines is a long, difficult and expensive process:
Preclinical Testing --> Investigational New Drug Application (IND) --> Clinical Trials, Phase- I --> Phase-II --> Phase-III --> New Drug Application (NDA) --> Approval --> Phase-IV.
SAS-programming is very important from preclinical testing to approval stages. Here, when you see the sequence of drug development and approval process you can yourself realize how important clinical trials and SAS-programming areas are and there is an urgent need of starting training programs in these areas.
Training program on how to effectively monitor clinical trials can be designed based on Good Clinical Practices and ICH guidelines. Various topics may include: design of protocol, case report forms, reporting serious adverse events, early phase clinical evaluation, processing clinical research data, clinical database, data display, report and analysis plan, clinical trial report, standard operating procedures in regulatory affairs, auditing of clinical trials and new drug application etc.
Clinical trials data arriving on case report forms is fairly standard, for example demography, adverse event, medications, laboratory etc hence can be stored in fairly standard data structures. Designing clinical data structures for data entry is important, but it should be done with some understanding of the analysis that will be performed. Once an appropriate clinical data structure is arrived at for data entry, it is important to then determine how to best use the data in the SAS analysis environment.
US FDA considers SAS validation an important component of the quality assurance, reliability & accuracy of much of the information used to approve & develop drugs and medical devices. Hot spots and crucial points in pharmaceutical research & developments are submission of various clinical reports to FDA and these clinical reports need to be created using SAS-programming techniques.
Different Phases in Clinical trilas and SAS programming include:
(1) Clinical Report Generation for example:
(a) Adverse Event tables and listings,
(b) Demographics,
(c) Safety,
(d) Efficacy,
(e) Lab Data,
(2) Custom Derived SAS data sets,
(3) SAS-Programming for NDAs (New Drug Applications),
(4) Experience with Phases I-IV,
(5) Data Cleaning,
(6) Statistical Analysis using SAS tools and
(7) Data Warehousing.
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