Survival Analysis - SAS

A SIMULATION STUDY OF ESTIMATORS IN STRATIFIED PROPORTIONAL HAZARDS MODELS

RISK EVALUATION AFTER HEART VALVE REPLACEMENT BY SAS PROC PHREG

Everything to know about Clinical Trails

Clinical Trails 

A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest ways to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people of populations in natural settings.

Protocol

All clinical trials must be conducted according to strict scientific and ethical principles. Every clinical trial must have a protocol, or action plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary - including details such as the criteria for patient participation, the schedule of tests, procedures, and medications, and the length of the study.

Phases of Clinical Trials

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Below are the links to papers published in various SAS User Group Meetings which are very informative to any SAS programmer: novice or seasoned


Clinical Trails Basics

SAS Programmer to Clinical SAS Programmer

Clinical Programming for Novice

Clinical Trials terminology for SAS Programmers

Managing Clinical Trials Data using SAS Software 

Clinical Trial Terminology

Clinical Study Design and Methods Terminology

Clinical Trial Terms

Annotate CRF
 
Annotate Case  Report Form Automation System

A Regular Language: The Annotated Case Report Form


Table, Listing and Graphs

Pharmaceutical Programming: From CRFs to Tables, Listings and Graphs, a process overview with real world examples

Creating Tables or Listings with a Zero-Record SAS® Data Set -- Basic Program Structure and Three Simple Techniques

Clinical Trial Reporting Using SAS/GRAPH SG Procedures

Show Your Graphs and Tables at Their Best on the Web with ODS 

Creating Clinical Trial Summary Tables Containing P-Values:A Practical Approach Using Standard SAS Macros

Clinical Trials Validation 

The 5 Most Important Clinical SAS Programming Validation Steps

A Simple Solution for Managing the Validation of SAS Programs That Support Regulatory Submissions   


Clinical Trials Submissions

Data Definition Tables – Definition and Automation


Acknowledgements:
U.S National Library of Medicine