Clinical trials programming using SAS, SAS Clinical or Clinical SAS all are one and the same. what is clinical trial?. In the present situation what is the importance of clinical trials?. why we are going to do the programming in clinical trials?
Clinical trials are the experiments which are performed on human participants, Which are designed to answer Specific questions on biomedical interventions. They are the primary designed to find out whether a new treatment, a new drug, or a new medical device, or new diagnostic or surgical procedure is safe and effective to use on humans.
clinical trials generates the data on the dosage, Safety and efficacy of a new drug or procedure. clinical trials are carefully designed and they are reviewed from time to time and need to be approved, before launching the new drug, procedure or device into the market, it has to be approved by the local regulatory body such as FDA (Food and Drug Administration).what is the need of this clinical trial? Why we are going to do programming in the clinical research?
In the present situation, of global pandemic and the medical emergency we are facing, it is clear that still we are lacking behind, we don’t have a sufficient knowledge, We are unable to face the catastrophic effect of the pathogens and the microbes which are affecting globally . Every person on the globe effected directly or indirectly With COVID-19. This is not the first time, in this decade recently, we had many such microbial attacks. for example, the H1N1 influenza, the EBOLA virus. Now at present we have COVID-19. So all these events forcing the scientists throughout the globe, inviting the big pharma companies in doing pharmaceutical research , to find out the solution and help the mankind to stand firmly in such situations , For this reason the clinical research is on boom, and in the recent decade has shown exponential growth.
Clinical research generates a huge data. This data has to be stored , analyzed, has to be managed carefully, and finally to be protected. These data is actually critical for the research companies because the fate of the drug which we are going to launch in the market, whether it will be approved or rejected depends on this data. So , we need a dedicated and trustworthy software to carry on all these tasks mentioned above, We need a software to store, manage , Analyze the data to answer the research question and generate meaningful outcome. Also, We need a software which is also secure, to protect the data, which should not be open source, because open source software actually are not safe. The research companies investing a huge amount of money, we cannot trust open source software . moreover, we need a versatile simple software with user-friendly interface, but simultaneously can perform complex tasks. So, SAS is the answer for all these questions
SAS is nothing but statistical analysis software. It was developed long back in 1960s by SAS institute based in North Carolina, USA. with intention to carry out simple statistical analysis. with the passage of time and as per the current need, a lot of changes were made in SAS.
SAS was launched in versions like SAS 7 , SAS 8, SAS 9.1, SAS 9.2, SAS 9.3 and SAS 9.4 . So now SAS is a full-fledged software to carry out variety of complex tasks, not just static analysis, SAS is used in data management, advanced analytics, multivariate analysis, in business intelligence , criminal investigation, predictive analysis and moreover, also in the clinical trials.
SAS is one of the most commonly and widely used software. SAS can Mine, alter, manage and , analyze the data, and also it can read the data from variety of sources in variety of file formats such as text, Excel, CSV, and even from databases. After analyzing, the output can be generated in the different file formats like Word, Excel, HTML, CSV, Pdf, Power Point and even database file.
So, SAS can retrieve the data from the different file formats and can generate the output in the form of variety of file formats. Even other software such as SPSS can generate the output in SAS file formats.
SAS can carry out the complex analysis, but still SAS is versatile and user friendly. SAS is having the user-friendly click interface for the non-technical users who don’t have any prior exposure to SAS. Even the users coming from other background such as Oracle, COBOL, FORTAN etc. need not to abandon their previous experiences, they can still use their knowledge in SAS programming.
Moreover, SAS can perform descriptive as well as inferential types of statistical analysis. Now, what is the use of SAS in the clinical research? Why only the SAS? In the market we have so many other software such as Python, R, SPSS and so on, but why we want to choose only SAS . The answer is that SAS is not a new software, it is already established in the market. It was launched in 1960s, so the people know the SAS in the industry. And moreover, SAS can read from variety of sources and can generate the output in the variety of file format. Also, SAS is secure(not an open source software) and it been used in clinical research since long time .It is one of the widely used software in clinical research industry. Finally, the data submitted to the regulatory bodies such as FDA are submitted in SAS Transport file format(.xpt) .
In Clinical Trials SAS play vital role , not only doing the statistical analysis, But also in protocol development, in randomization process, In CRF designing, in adverse event reporting and so on.
SAS is also used in Clinical Data Management, in inserting, retrieving, altering and updating the data in the databases through SQL.