Clinical Trials Terminology for SAS Programmers

Introduction
The drug development process is a clinical process that has its own language. It is not required that SAS programmers function as a MD or a regulatory expert, but working knowledge of the terminology is important to be effective. This section will walk through the drug development process from discovery to Phase IV. It will explain a wide range of acronyms such as IND, NDA, GCP and MedDRA. It will also describe some of the terminologies used within the process of clinical trials as a drug is developed and submitted to the FDA. This will give SAS programmers a larger perspective and context to their work during the analysis and reporting of clinical trials data.

This section will tell a fictitious story about a college graduate named James who is starting a new position at a pharmaceutical company. Each new term James encounters is presented in bold and italicized for emphasis. As he enters a new professional world, he meets many people and learns new processes that are filled with unfamiliar vocabulary and acronyms. As James settles into his new job as a SAS programmer, he learns the meaning of these terminologies and becomes more productive in his work.

Getting the Job
After an enjoyable summer of R&R following his graduation from the University of California, James browses through the wanted ads to confront the adult world of employment. James only has a vague notion of what a Pharmaceutical company does in that it performs research and development of drugs. He sees advertisements for Biotechnology companies which is a general term used to explain a technique of using living organisms within biological systems to develop micro-organisms for a particular purpose. The end products from Biotech and Pharmaceutical companies are usually drugs or medical devices. These companies form what is sometimes referred to as the Biopharmaceutical industry.

James was successful at acquiring a job as a Statistical Programmer which requires him to program using the SAS language to analyze clinical data and produce reports for the FDA. He was familiar with the Food and Drug Administration from hearing on the news about certain drugs on the market that were being recalled due to safety issues. He is learning more that this organization sets many of the regulations that affect his job. During his search, he also saw other job titles including: Bioanalyst, Clinical Data Analyst, Statistical Programmer Analyst and SAS Programmer. It turns out that different companies have different names for the same job.

Starting the Job
James started his first day in a small cubicle at Genenco, and his only interaction was with Barbara, a Biostatistician, who was also his boss. James’ degree included many statistical courses but a PhD in statistics was required to function in the position that Barbara had within the biostatistics department at Genencco. After setting James up with a computer account along with the fastest desktop computer that he had ever laid his hands on, Barbara delivered a big binder which contained a Protocol for his first clinical study. It was a monster document that must have been at least a hundred pages. The protocol outlined all the procedures and contained detailed plans of the study. It had the study design containing the statistical methodology and acted as a road map for all team members involved in conducting the study. James’ first task was to read and understand what the study was all about. He was new to clinical trials and was just learning about the concept of a controlled experiment. The protocol explained how the clinical trial had patients grouped into different groups such as those in the placebo controlled group which had no active drug. This is how comparisons are made within the controlled clinical trial.

more to come in the book I am working on "Becoming a SAS Programmer in the Pharmaceutical Industry"....