Introduction to the Drug Development Process

The drug development process within the United States and Europe is a complex process containing multiple interwoven steps that have both social and economic impact. This chapter is not intended to elaborate on all the fine points of drug development, but rather provide the essential information in order for you to see the bigger picture.

In the late seventies, there was a Saturday morning cartoon series named “School House Rock”. It took various academic subjects such as mathematics and grammar and distilled them into musical cartoons which fashioned novel rock and jazz tunes with clever rhymes. Its success was in its ability to take complex and detailed sets of ideas and teach them in a way that the audience did not know they were watching a lesson. It was entertaining yet educational.

The particular cartoon named “I am just a Bill” described the legal process of how a Bill is drafted and then progresses through legal wrangling, finally resulting in becoming a law. It had a tongue and cheek approach in making the main character named Bill, a legal document. It was entertaining since it gave personality to the Bill and showed how he had to jump through many hoops before being approved. The catchy “I am just a Bill” tune kept the audience engaged while describing what otherwise would be a dry and rather boring legal process.

This chapter is analogous in theme and uses the drug, as in “I am just a drug”, to describe the drug development process. It does not include fanciful rock tunes with hooks but does take a similar light hearted approach in fictionalizing a life of a drug as a living breathing character. This approach will accomplish the task keeping the information engaging while also imparting details that are needed to gain perspective in becoming a SAS programmer or statistical analyst.

I am just a little drug but am very fortunate to have large teams working with me including a lead doctor acting as the main investigator, Irving. He has decided that during the clinical trial, I will be compared to a placebo which is a non- active “sugar pill”. In addition, I will also be compared to another drug on the market to see how I compare. These separate trial arms can really show if I truly have the right stuff. The team that Irving hired has spent a tremendous amount of time planning how and whom they are going to include in these trials. They want to make me shine by picking people that fit the profile of the type of conditions for which I am intended to cure.

They had these poor people in the clinical trials go through considerable efforts as a way of measuring if they are getting cured and that I am safe for them. For example, the patient had to have blood drawn and they measured all the vital signs to see if the patient was showing any signs of illness. All the information that is collected is captured through an EDC (Electronic Data Capture) method and is then sent to the research facility for analysis. This is where they laboriously develop SAS programs to slice and dice the information to show that I am safe and do help people.

There were multiple trials that I went through in attempt to prove many different objectives. On my first study, the group of patients was very specific since they were all elderly patients with stage 1 breast cancer. They wanted to see how I would perform on this specific group of diagnosed patients. I only had minimal success in this trial so they put me on a new study where the dosage was increased to 10 mg. I was really nervous since the level of toxicity would increase as well. I have proved however that this increase in dosage did help the patients while not making them sicker.

All the studies that my parents had put me through are organized into these logical phases. When I started out in the studies in Phase I, they were small groups of under 100 healthy volunteers to confirm dosage and safety, but Phase II grew much larger in size. Some of the initial studies in Phase II were referred to as Phase IIA which was designed to confirm how much dosage of me the sick patients could handle. Their reactions were different than the healthy volunteers so this was important to evaluate. Another group of studies in Phase IIB were designed to see how these dose differences affected whether the patients were getting more relief or healthier from their cancerous condition. This was the beginning to see if I can really help sick patients. Barbara who was the lead statistician was very clever in assigning groups of patients into their own distinct treatment groups in a “randomized” fashion for comparison. In this case, I was never introduced to some groups of patients since they had sugar pills instead but this allowed them to see if they were sicker without my assistance.

more to come in chapter 1 of book "Becoming SAS Programmer in Pharmaceutical and Biotech Industry"...
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