Just like everything else that needs to be tested to ensure that every bell and whistle works, pharmaceutical drugs and the companies that make them, are in need of funding and trails to give the public a reason to use their drug. Its similar to the same process a new car goes through when it’s first introduced, it needs to be tested and corrected in order to determine its gas mileage, its safety rating, and even the price of cars. This works the same way with drug companies and the FDA.
Clinical trial is the most dreaded part of drug discovery. It is feared by every pharmaceutical researcher as well as pharmaceutical companies. The money and the manpower that is put into discovering a drug is dependent on the clinical trials to fructify. It is only after this necessary obstacle that the drug will get into the hands of the customers, and the drug maker will generate profit. Millions of dollars are spent by pharmaceutical companies on discovering a drug from thousands of potential candidates. This discovered drug goes through a phase of development that makes this drug more effective and its production cost effective.
Pharmaceutical education’s sole goal is to pass this one trial which is actually five trials in one. This trial is done to find the efficacy and safety of a potential drug. It does not matter if the drug is for a cough or a cancer; it has to go through this phase to prove itself sufficient to replace the current best medicine in the market. Both the pharmaceutical and biotechnological drugs need to meet the stringent norms of the clinical trials. The clinical trials include four to five clinical trial phases with one pre-clinical trial phase. The pre-clinical trial is carried in vitro and in vivo to gauge the toxicity, efficacy and pharmaco-kinetic characteristics of a drug. The following four phases are conducted in humans, with every phase seeing an ascending number of human test subjects in each phase. The final phases see the participation of patients for whom the drug is manufactured in the first place. It’s only if the drug cures these patients better than its competitors in the market and without any or minimal side effects will it be given the green light. Until Phase IV, the drug is uncertain to be tested on a real patient.