SAS programming , with discussion , hands on experience with example

SAS programming , with discussion , hands on experience with example Clinical SAS Programming discussion , online classes , free learning experience

12/28/2023

Why to learn SAS?

SAS is software where in they can use it in their domain and it is comparitively easy to learn as SAS® is neither a menu-driven nor a command driven application. Rather it relies on user-written scripts or “programs” that are processed when requested to know what to do. Because it is a script-based application, the key to being successful using SAS is learning the rule and tricks of writing scripts.

• Can process large data set(s)

• Easy to cope with multiple variables

• Can track all the operations on the data set(s)

• Can generate systematic output

• Summary statistics

• Graphs

• Regression results

WHY SAS IS THE ANSWER:

Clinical data is sensitive information that should be treated as a valuable asset as well as a regulated commodity. Not only can improper management of clinical data cause the invalidation of an entire clinical trial, but it may also result in strict remedies, including serious financial penalties, from the FDA.

At the time of this writing, the FDA has not issued revised CFR 21 Part 11 guidance. This indicates that the FDA is still struggling with the difficult issue of Part 11 requirements compliance for a clinical database. However, it is known that the FDA does request that all clinical DBMS prevent unauthorized access to data. This requires that data be password protected and allow updates only by authorized users of the clinical DBMS.

The FDA also requires maintenance of complete audit trails for clinical data. Both the entry and revision of clinical data is to be logged to indicate the user performing the action, the date and time of the action, as well as the reason for change of data.

These requirements and many others are all easy goals when working with the SAS System. In addition to being easy to use, SAS is also the choice of the FDA for receiving and reviewing clinical data. The FDA is still requesting SAS transport data sets as the standard for receiving electronically submitted data. At a minimum, each FDA reviewer is equipped with the SAS System Viewer.

Since the use of SAS is essential to clinical information management, keeping clinical data in SAS makes sense. SAS is the government and the industry standard for performing clinical analysis. Reporting is also effectively accomplished using SAS.

 Who can pursue SAS

Graduates & PGs from any discipline (MBAs, Commerce, Engineering Life sciences, Arts, Medicine, MCAs Statistics etc) can learn SAS.

 Applications

SAS applications are used in
• Financial Services
• Banking
• Insurance
• Retail
• Manufacturing
• Media
• Education
• Communications
• Government
• Hospitality & Entertainment
• SAS Solutions for Small to Medium Businesses
• Aerospace
• Health Insurance
• Automotive
• Energy & Utilities
• Life Sciences
• Government
• Federal Government
• State Government

In the given industries SAS can be used in the following areas

• Customer Relationship Mgmt
• Financial Intelligence
• Human Capital Mgmt
• Profitability Management
• Performance Management
• Risk Management
• Business Intelligence
• Reporting
• Query & Analysis
• Microsoft Office Integration
• Forecasting & Econometrics
• IT Management
• Activity-Based Management
• Compliance (Basel II, Sarbanese Oxly Act etc.)
• Service Intelligence • Supplier Intelligence
• Supply Chain Intelligence
• Web Analytics
•On Demand Solutions
• Data Integration & ETL
• Connectivity & Metadata
• Data Cleansing & Enrichment
• ETL
• Migration & Synchronization
• Data Federation• OLAP
• Integrated Analytics
• Visualization
• Analytics
• Statistics
• Data & Text Mining
• Optimization
• Model Mgmt. and Deployment
• Quality Improvement
• Enterprise Intelligence Platform
• Data Integration & ETL
• Business Intelligence
• Analytics

12/28/2023

What you should know about the ISS/ISE (ISR) ???

There are many reasons to integrate and to summarize all the data from a clinical trial program. Each clinical trial in the program is unique in its objective and design. Some are small safety studies among normal volunteers, while others are efficacy trials in a large patient population.

The primary reason to create an integrated summary is to compare and to contrast all the various study results and to arrive at one consolidated review of the benefit/risk profile.

A second and important reason is to reach a defensible statistical conclusion, through an exploration of the integrated data, that no competing alternative hypothesis that can reasonably account for the observed findings exists.

Third, pooling the data from various studies enables the examination of trends in rare subgroups of patients, such as the elderly, those with differing disease states (mild vs. severe), and those with comorbidities at baseline. Last, providing such a summary in the new drug application is required by the Food and Drug Administration (FDA) and other international authorities.

ISS will have all the clinical trial data, collected form a normal volunteers (from phase 1 study) and patients (all other studies).

ISE will have the clinical trial data only from the phase II and Phase III and phase IV and not of Phase I. The reason behind this is, Phase I study is conducted to identify the safety and not the efficacy of the drug, so the data from the Phase I study will not be there in the ISE.

ISE should have a description of entire efficacy database demographics and baseline characteristics.

ISS should have the details including the extent of the exposure of drug by the patient, different characteristics of patients enrolled in the study, listing the deaths occurred -during the study, How many patients are drop-outs from the study and Potential SAE, other AE and lab results.

ISS is considered as one of the most necessary document required for filing the NDA (new drug application). The safety data from different trials can be integrated by pooling all the safety data together and then to identify the AE, that are rare. The data integration approach for the ISS and ISE are entirely different, whereas pooling the efficacy data from different studies is not required, although pooled data will give more information regarding the efficacy of the drug. Pooling all the safety data is necessary in making the ISS. ISS needs a thorough research because it involves with the safety and safety parameter is considered important than the efficacy in a clinical trial, because study should always benefit patients.

ISR (integrated summary report):

It is a compilation of all the information collected from the safety and efficacy analysis in all the studies. ISS and ISE are different parts of ISR. Both the ISS and ISE reports are necessary for all the new drug applications (NDA) in the United States.

Every clinical trial is different, because each one is conducted for a specific purpose (Phase I for safety in normal population and all other for efficacy in patients).

The reason behind creating the ISR will be to create an integrated report to compare and to differentiate all other study results and to get one conclusion after reviewing the patient benefit/risk profile. It requires by the FDA is the other reason. Last but not the least reason for this is to reach a definite conclusion through thorough checking all the data which is integrated.

07/04/2022

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