SAS (Statistical Analysis System) clinical is one of the applications of SAS for the clinical trial data analysis in clinical research, biotech/pharmaceutical companies. With clinical knowledge, a SAS programmer can have the capability to take his own decisions while programming. The responsibility of a SAS clinical programmer is to generate the outputs like figures, tables and listings which are needed for the reporting and analysis of the clinical data. It is also used to predict the usage of drugs by seeing the trends and varying the dosage levels.
Phases of Clinical trials:
The following are the four phases of clinical trials:
Phase 1: For the evaluation of safety a new test is implemented which is nothing but to test treatment or a new drug. This is happening for 20-30 people.
Phase 2: To check that the drug is effective or not this experimental treatment or drug is given to nearly 100-300 people.
Phase 3: For to monitor and to see the effectiveness this experimental treatment is given to large groups of people may be around 1000-3000.
Phase 4: This is the final phase in which it has the post-marketing studies like benefits, risks etc.
How can drug validation process be done?
In this, the validator is used to write the program if in case the program output is the same as that of the SAS programmer’s output then we can say that the program is valid. The main objective of the validation procedure is to check the SAS program output which was generated by source programmer. SAS clinical is used to support the strategic analyses and used to analyse data sets.
Rules and Regulations of the Pharmaceutical Industry:
There are many rules and regulations which rule the pharmaceutical industry. The SAS programmer should follow that rules.
The rules are categorised into three types.
- Industry laws
- Federal laws and
- Federal guidelines
- Industry laws:
- The pharmaceutical industry driven by the shareholders’ profits and was artificially created, but strategically developed with the same investment group for the entire century.
- New drugs patenting are the key reason for the pharmaceutical industry’s huge profits. Drug manufacturer can achieve despotic profits for these patents.
- The human body is the marketplace of the pharmaceutical industry, but it is considered only as long as the body entertains disease. Thus expanding and maintaining the diseases is one of the growth factors for the pharmaceutical industry.
- The development of goal can be possible with the development of drugs in the process of avoiding or elimination of diseases. To improve theirs for further extending the drug companies are searching for new applications for the drugs’ usage which are already there in the market.
- Federal laws:
- How things and information are handled can be ruled by using federal laws. If these laws become violation, then it leads to the federal government prosecution. Guidelines of federal laws are nothing but the suggestions given by the federal government in the form of formal lists for let to know the industry how to submit and conduct trials for the approval of drugs.
- There is no any penalty or punishments if the guidelines are the failure to follow and sometimes only it leads to the government to refuse the approval of the drug.
- The federal regulation code belongs to drugs and food. Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) plays a major role in the laws of federal regulations.
- Although many communication channels are there, Food and Drug Administration (FDA) reached the expectations and requirements of New Drug Application (NDA).
- Federal guidelines:
- Federal guidelines are nothing but the set of documents published by FDA to know how information can be submitted from clinical trials.
- One of the older guidance document is to provide regulatory submissions in the form of electronic-General considerations.
- This guidance document is used when there is a need in how to structure the data files and them which file is acceptable.
Validation steps for SAS Programming:
The SAS programmer’s validation work is one of the most important tasks in the pharmaceutical industry. It is because the pharmaceutical industry is based on the set of rules governed by the federal laws. Accuracy reporting is one of the crucial parts because the life of many people depend on it. There are many rules and regulations in the process of presenting and analysing clinical data. In the year 1996, The Health Insurance Portability and Accountability Act was implemented for the benefits of people for the group health. HIPAA impact on day to day work has less priority, but it is very important to know that the law exists and should have the general idea of its purpose.
Giving correct Information:
Subject health care’s important decisions depend on the programmer’s output. The information should be appropriate, and there shouldn’t be any mistakes. If there is any incorrect information, then it leads to the risk of people’s lives. Somehow there is pressure from the industry to produce faster output, but the decision making should be controlled based on the health of the people.
Should have a proper plan:
Whenever we are going to start a program first, we should know to have the proper plan. Unless the proper plan the program output couldn’t be the same as we expect. We have to perform the task by gathering all the sources. It helps a lot in recognising data and also to check the original data went correctly or not.
There are mainly two techniques to approach the output validation. They are independent programming, separate and peer review.
Depending upon the times, SAS programming can be unstructured. The data plays a major role and helps in decision making for many organisations. If the structure and format of the validation process are not in the correct process, then it leads to huge results. The SAS programming’s ad hoc nature creates an environment that is not strength to the accuracy and consistency. This leads to the production of the uncontrolled environment.