The trial process
Please be very clear that Synexus is only involved in running Phase II and Phase III Clinical Studies, but we will outline the entire process for you.
The first step is Pre-Clinical Testing and this can take anything from 1 to 6 years to complete. During this stage scientists determine whether or not a drug is worthy of being tested on humans, and what the potential benefits and side effects may be. If this stage of extensive testing proves the drug to be effective, the pharmaceutical company moves to the next stage, filing an Investigational New Drug (IND) Application with the FDA.
The Investigational New Drug (IND) Application gives very specific details on the chemical structure of the drug, how it operates, Pre-Clinical Testing results and detailed plans of the next stage, involving human testing. If the FDA approves the IND human clinical studies can begin within 30 days and are known as Phase I, Phase II and Phase III Clinical Studies.
The aim of the Phase I Clinical Study is to determine if the drug has enough benefits to warrant further testing. Many drugs do not make it past this stage as researchers look at things like absorption and elimination by the body, effects on organs how the drug mixes with other chemicals and side effects.
The Phase II Clinical Study is the first of the studies Synexus specialise in managing. It's focus is to test the safety and effectiveness of the drug as it pertains to the condition it is intended to treat. This phase can take up to 3 years and 300 participants to complete. Complex measures are taken to remove any bias or fabricated results on behalf of both researchers and patients. If the results of Phase II are positive, the drug may move onto Phase III.
Synexus are also adept at managing Phase III Clinical Studies. Phase III takes the safety and effectiveness testing even further and takes between 2 to 4 years and 1000 or more participants suffering from the targeted disease or condition. Even at this stage, if the study produces negative results, the drug may be quickly dropped from further testing. If the results are clear and undeniably positive, the pharmaceutical company may move to the next step; filing a New Drug Application (NDA) with the FDA.
The NDA is a comprehensive report that must be submitted to the FDA for extensive review. The report details the drugs chemical structure, all information learned from Phase I, II and III study testing. The FDA weighs all this information and determines whether or not the drug is worthy of approval for public consumption. The FDA further requires that the pharmaceutical company submit ongoing reports as use of the drug becomes more common.
As you can see, getting a new drug onto the shelves is not a simple task, and everything is done to restrict the chance of dangerous drugs becoming available.