Friday, November 1, 2013

A 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 value of the new therapy and its side effects against various already established therapies in the market.

Different stages of Clinical Trial include the following phases-

Phase I- the researchers test a test medication or therapy in a small individual (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 give the more details such as the drug's threats, benefits, etc. Before coming into this test, FDA acceptance is essential.

SAS (Statistical Analysis Software) is a solid tool for confirming and analysis. Mr. Jim Goodnight released this software in the year 1976 for the statistical analysis performs. This is generally used to access the details in a different application, adjustment of the details, and removal of clinical details from various resources, analysis and selection of the details. This device is solid in working with medical details. This tool is used to perform modify assessments, cross-form modifies assessments, acceptance reviews, conclusion reviews and transfer of data files per attract requirements, company requirements and Clinical Data Inter Change Standards requirements. The present edition of SAS being used is 9.3.

Role of a SAS programmer is data analysis, validation of the evaluated data sets, data removal, modify assessments, acceptance, and distribution perform.

Clinical Data Inter Change Standards:
Clinical Data Inter Change Standards Consortium is a non-profit company utilized to develop industry requirements to support purchase, exchange, distribution and preserving of scientific test details for medical and bio pharmaceutical service.

Important models 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 individual journal, etc.

ii) Analysis Data Model - it describes a standard for analysis data sets 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 - it describes a conventional framework for data tabulations that are to be posted as part of an item application for a regulating power such as the FDA. The current edition being used is 3.1.1 SDTMIG.

iv) Laboratory Study Model - it works towards the growth of a conventional model for the purchase and the interchange of lab details which is the biggest component of the Clinical Trial data.


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