Clinical Research Methodology

Abstract:

Medical trials occupy a greater part of clinical trials and exceed in number over other types of clinical trials. Although clinical researches or studies other than those falling under the category of trial, lack the commercial aspect, they may contribute to the betterment of clinical practice and may constitute a base for large-scale commercial trials. Explanatory clinical studies are the most widely accepted and executed type of clinical researches/ trials. They explain not only the therapeutic aspects of a drug but also provide with a detailed description on adverse events and pharmacovigilance. Any new drug to be marketed first requires proving its safety, efficacy and the need over existing product range by passing through various phases of clinical trial that follows animal studies. For this reason, randomized controlled trials (RCTs) with placebocontrol and blinding fashion is the only accepted form of clinical trials with few exceptions. Besides explanatory, descriptive clinical research is also useful for certain types of studies such as epidemiological research. While conducting RCTs on humans (either healthy volunteers or patients), various components of the trials viz. study design, patient population, control group, randomization, blinding or non-blinding, treatment considerations and outcome measures are important to strengthen the outcomes of the trial. Similarly, proper utilization of statistics, for sample-size calculation, data collection, compilation and analysis by applying proper statistical tests, signifies the outcomes of the clinical research. The presented article includes a brief, however, an informative review of literature on methods in clinical research including clinical trial.

KEY WORDS: Clinical research methods, Clinical trial methods, Statistics in clinical research.