SAS – A Statistical Tool for Life :
EpochResearch Institute India Pvt Ltd. (SASAuthorised Training : Ahmedabad | Bangalore)
Clinical trial is a research conducted in human volunteers to assess the protection and effectiveness of the investigational Drug/molecule. It helps investigators to better evaluate the effectiveness, the therapeutic value of the new therapy and it’s side effects against various already established therapies in the market.I have described the four stages of Clinical trials with images below for you to understand more better.
Initially I want to describe with you the role of SAS in Clinical field.Following pic will let you know about.
Next comes different phases of Clinical trial:
Different stages of Clinical Trial include the following phases-
Phase I- the researchers test a test medication or therapy in a small individuals (20-80) for the first time to assess its protection, determine a safe dose range and recognize its complication.
Phase II- the test research medication or therapy is given to larger individuals (100-300) to see its efficiency and to further assess its protection.
Phase III- the test research medication or therapy is given to large groups of individuals (1,000-3,000) to validate its efficiency, observe adverse reactions, compare it to commonly used treatments, and gather details that will allow the test medication or therapy to be used securely.
Phase IV-it is generally the post marketing studies which gives the more details such as the drug's threats, benefits, etc. Before coming into into this test, FDA acceptance is essential.
CDISC(Clinical Data Interchange Standards Consortium):
The important models of CDISC are-
i) Operational Data Model (ODM) - it helps the activity of clinical details gathered from several resources to one operational data source. The resources of the details are paper CRF, eCRF, individual journal, etc.
ii) Analysis Data Model (ADM) - it describes a standard for analysis data set that are used to generate mathematical reviews for regulating syndication. The data set should be ready for analysis to be conducted using SAS techniques directly without any further perform on the details.
iii) Study Data Tabulation Model (SDTM) - it describes a conventional framework for data tabulations that are to be posted as part of a item application to a regulating power such as the FDA. The current edition being used is 3.1.1 SDTMIG.
iv) Laboratory Study Model (LSM) - it works towards the growth of a conventional model for purchase and interchange of lab details which is the biggest component of the Clinical Trial data.
I hope so you will find this post quite helpful to understand related to Clinical SAS field. If any queries can provide me with comments.
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