Historical Perspective and Fundamentals of Clinical Research

Abstract

‘Research’ may be defined as any activity that generates new knowledge and a better understanding of natural phenomena, while ‘scientific research’ uses scientific methods to explore and discover new facts and uses the new knowledge to solve practical problems and explain natural phenomena.¹Simply put, research is an organized process of finding solutions to perceived problems and usually begins with either a simple observation or an unusual experience. The World Health Organization (WHO) has defined “Health Research”as “a process for obtaining systematic knowledge and technology which can be used for the improvement of the health of individuals or groups. It provides basic information on the state of health and disease of the population, aims to develop tools to prevent and cure illness and mitigate its effects and attempts to devise better approaches to healthcare for the individual and community”.² According to the United States Department of Health and Human Services (DHHS) Definitions (45 CFR 46.102), research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” while the Belmont Report defines research as  “any activity designed to test a hypothesis, permit conclusions to be drawn and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships)”.³According to the DHHS, a human subject is a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information.³

Scientific research dates back to many centuries.⁴The earliest reports are found in the Egyptian papyrus dating back to 17th century BC.  Hippocrates of Kos (460BC – 370 BC was generally regarded as the father of Medicine.Edward Jenner (1749-1823) will be remembered for his invention of the smallpox vaccine which was a scourge at that time; Alexander Fleming (1881-1955) discovered Penicillin which provided cure for bacterial infections; Alfred Nobel (1833-1896) discovered dynamite which was used for blasting rocks and made possible construction of roads through tunnels etc. He instituted the Nobel Prize in 1895 in recognition of academic, cultural and/or scientific advances. The Nobel Prize represents the hallmark of excellence in research and innovation. Fredrick Banting (1891-1944) and Charles Best (1899-1978) discovered insulin in 1921 and won the Nobel Prize for their work in 1923.⁴