Clinical Research - Bioethics


Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medicationsdevicesdiagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.


The term "clinical research" refers to the entire bibliography of a drug/devce/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.

Clinical research is often conducted at academic medical centers and affiliated research study sites. These centers and sites provide the prestige of the academic institution as well as access to larger metropolitan areas, providing a larger pool of medical participants. These academic medical centers often have their internal Institutional Review Boards that oversee the ethical conduct of medical research.

The clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. This has led to a growing field of technologies used for managing the data and operational factors of clinical research. Clinical research management is often aided by eClinical systems to help automate the management and conducting of clinical trials.


Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies.

Phase I includes 20 to 100 healthy volunteers or individuals with the disease/condition.This study typically lasts several months and its purpose is safety and dosage. Phase II includes larger number of individual participants ranging 100-300, and phase III includes Approximately 1000-3000 participants to collect more data about the drug. 70% of drugs advance to the next phase.

Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.


Alice Maria
Journal of Clinical Research and Bioethics
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