Statistical Programmer Work Description

Phase 1 trials are the first in man studies of a new drug in humans. These studies are usually carried out on small samples of subjects. The idea here is to determine the safety of the drug in a small and usually healthy volunteer study population. 

Phase 3 trials are large-scale clinical trials on populations numbering in the hundreds to thousands of patients. These are the critical trials that the drug maker runs to show that its new drug is both safe and efficacious in the target study population. If the phase 3 trials are successful, they will form the keystone elements of a New Drug Application 

Phase 4 trials, or post-marketing trials, are usually conducted to monitor the long-term safety of a new drug after the drug is already available to consumers. 

There are other trial design concepts for you to be aware of. A clinical trial can be carried out at a single site or it can be a multi-center trial. In a single-site trial all of the patients are seen at the same clinical site, and in a multi-center trial several clinical sites are used. Multi-center trials are needed sometimes to eliminate site-specific bias or because there are more patients required than a single site can enroll. 

Trials may be designed to determine equivalence or superiority between therapies. An equivalence trial is designed to show that there is no clinically significant difference between therapies, and a superiority trial is intended to show that one therapy is significantly better than another. 

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