Basics of Clinical Drug Development: Clinical Trial and Drug Development

The development of new drugs typically goes through various complications and requires the involvement of distinct scientific streams. Extensive preclinical studies that provide the initial information about the efficacy, toxicity, safety, and pharmacokinetics of the drug decide whether it goes for the clinical trial. Clinical trial of a drug is executed in four different phases (phase I, II, III, and IV). Different types of trials are based on observational (non-experimental) and experimental designs. In the observational study, there is no intervention or manipulation in a group of people. Experimental design (randomized control trial) proves to be the most convincing and is thought to be the most dependable way to study the effectiveness of treatment. Alongside these experimental designs, descriptive research is also very useful in the case of different studies, i.e., epidemiological studies. Besides all these suitable application of statistics for calculation of sample size, data collection, compiling, and analysis improve the outcomes of the clinical research. In this chapter, we have discussed the different methodologies used in clinical research and clinical trial.